[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-arterial-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-arterial-disease":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,114,0,25,[9,42,73,109,134,166,211,233,264,283,309,333,359,384,406,430,454,479,499,533,565,590,612,642,670],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100610131","phase-3-efficacy-and-safety-of-orforglipron-in-participants-with-peripheral-artery-disease-100610131",false,"NCT07223593","Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease","A Study to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants With Peripheral Artery Disease: A Randomized, Double-Blind, Placebo Controlled Trial","ATTAIN-PAD","Inclusion Criteria:\n\n* Have symptomatic PAD with intermittent claudication of Fontaine Stage II\n* Have an Ankle Brachial Index (ABI) of 0.9 or less\n\nExclusion Criteria:\n\n* Have a body mass index (BMI) less than 23 kilogram per square meter (kg\u002Fm2)\n* Have Hemoglobin A1c (HbA1c) greater than 10%\n* Have walking ability limited by conditions other than PAD\n* Have a planned lower limb surgery or any other surgery affecting walking ability\n* Had peripheral revascularization procedure within 90 days prior to the day of screening or planning to undergo peripheral revascularization during the clinical trial\n* Had stroke, transient ischemic attack, myocardial infarction, coronary or carotid revascularization, or hospitalization for unstable angina pectoris within 60 days prior to screening\n* Have heart failure presently classified as being in New York Heart Association class III - IV","ALL","18 Years",{"count":21,"type":22},1205,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to evaluate the effect and safety of orforglipron once daily in participants with Fontaine II peripheral arterial disease (PAD). Participation in the study will last about 58 weeks.",[28],"Peripheral Arterial Disease","RECRUITING","2026-08-20",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":33},"2025-10-31",{"date":37,"type":22},"2028-06",{"name":39,"class":40},"Eli Lilly and Company","INDUSTRY",159,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100089548","phase-1-fgf-1-for-intramuscular-injection-for-the-treatment-of-peripheral-arterial-disease-100089548","NCT00424866","FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease","A Phase 1, Open Label, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Peripheral Arterial Disease Patients With Intermittent Claudication","Inclusion Criteria\n\n1. Subjects considered eligible to enter the study must sign an informed consent form prior to the initiation of any study procedures. In the event that the subject must be withdrawn and is re-screened for study participation at a later date, a new informed consent form must be signed. Subjects must be competent to give written informed consent.\n2. Age must be ≥50 and ≤75 years of age with a life expectancy of \\> 1 year and leg survival \\> 6 months. Patients \\>75 and ≤80 years of age will be considered if they show no signs of cognitive or muscle function decline and are fully able to comply with the protocol.\n3. Patients must have experienced intermittent claudication for at least 6 months and have been stable for the past 3 months.\n4. Patients must have peripheral arterial disease, as confirmed by a resting ABI ≥0.40 and \\\u003C0.90 based on at least one leg as measured using both the dorsal pedis and posterior tibial arteries.\n5. Stenosis of \\>70% up to total occlusion must be present in the popliteal artery and\u002For in the tibial peroneal trunk or at least 2 tibial arteries above the ankle without inflow limitation of the popliteal artery. Adequate popliteal inflow is defined as continuous flow from the abdominal aorta, iliac, common femoral and superficial femoral with any stenosis \\\u003C 50% as determined either by intra-arterial DSA, CTA or Gd CE-MRA.\n6. The screening Gardner treadmill test peak walking times (PWT) must be \\>1 minute and \\\u003C 12 minutes and limited by pain in one or both calves.\n7. Preexisting medication regime must be stable for 6 weeks preceding dosing.\n\nExclusion Criteria\n\n1. Evidence of critical leg ischemia, i.e. ischemic rest pain or ischemic ulceration\n2. Treadmill walking limited by conditions other than intermittent claudication including arthritis, angina and dyspnea\n3. Lower limb amputation of, or in, either leg including toes\n4. Evidence of limb ischemia from immunologic or inflammatory disorders\n5. Leg surgery or revascularization within past 6 months or peripheral angioplasty within past 3 months or anticipated during study\n6. Participation in any investigational device or drug trial within the past 6 months\n7. Myocardial infarction, unstable angina, stroke or ischemic attack within past 6 months\n8. New York Heart Association (NYHA) class II, III or IV heart failure, restrictive or hypertrophic cardiomyopathy or severe valvular disease\n9. QTc elongation greater than 450 ms in males or 460 ms in females\n10. PT (INR), PTT, urinalysis, thyroid function (T3, T4, TSH) outside normal limits\n11. Hemorrhage or thrombotic events (e.g. deep vein thrombosis) within past 6 months\n12. Thrombocytopenia (\\\u003C100,000\u002Fµl), history of heparin-induced thrombocytopenia\n13. Major surgery with the past 6 months\n14. Positive proliferative retinopathy exam\n15. Present of any type of cancer or history of cancer except past (but not present) basal cell dermal carcinoma not on either leg\n16. Inflammatory or progressive fibrotic or myelofibrotic disorders\n17. Patients experiencing bacterial or viral infection (e.g. hepatitis or HIV) or who may otherwise be febrile\n18. Hemoglobin A1c(HgbA1c) of \\>8%\n19. Type I diabetes\n20. Total fasting cholesterol \\>200\n21. Uncontrolled hypertension (≥160 systolic or ≥100 diastolic pressure) or hypotension (\\\u003C90 systolic or \\\u003C60 diastolic pressure)\n22. Disease or drug (e.g. systemic corticosteroid) immuno-compromised\n23. Hepatic dysfunction as defined either by AST or ALT \\> 2.0 times the upper limit of normal\n24. Serum creatinine of ≥ 2.5 mg\u002Fdl\n25. Proteinuria (urine protein\u002Fcreatinine ratio \\> 3)\n26. Antiproliferative drugs (e.g. thalidomide, hydroxyurea)\n27. Radiation therapy\n28. Implanted devices not compatible with strong magnetic fields\n29. Life expectance of less than 1 year\n30. Females who are premenopausal and not sterilized or using adequate birth control or are either pregnant, intend to become pregnant or are nursing","50 Years","75 Years",{"count":52,"type":22},24,[54,55],"PHASE1","PHASE2","FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.",[28,58,59],"Stenosis","Intermittent Claudication",[28,61,59],"Ischemia","NOT_YET_RECRUITING","2026-08-17",{"date":65,"type":33},"2026-08-19",{"date":67,"type":22},"2028-10-15",{"date":69,"type":22},"2030-12-15",{"name":71,"class":40},"Venturis Therapeutics, Inc.",1,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100651640","dcb-outcomes-after-non-compliant-balloon-vessel-preparation-with-or-without-scoring-in-patients-with-femoropopliteal-arterial-disease-100651640","NCT07764016","DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease","Drug-coated Balloon Angioplasty After Non-Compliant Balloon Vessel Preparation With or Without Scoring for Femoropopliteal Arterial Disease: A Randomized Controlled Trial","DASBAD-NC","Inclusion Criteria:\n\n* ≥18 years of age.\n* Rutherford class 4-5.\n* Estimated life expectancy \\>1 year, per investigator's judgment.\n* Significant atherosclerotic lesions (≥50% stenosis or chronic total occlusion) in the femoropopliteal segment, including in-stent restenosis.\n* Signed informed consent.\n* Willingness to comply with follow-up visits.\n* ≥1 patent infragenicular artery (\\\u003C50% stenosis) at the end of the procedure.\n* Target vessel diameter ≤8 mm.\n\nExclusion Criteria:\n\n* Pregnant or planning pregnancy during the study.\n* Participation in another drug\u002Fdevice trial.\n* Inability to cross the target lesion with a guidewire. Successful crossing is defined as advancement of the guidewire tip distal to the target lesion without vessel perforation or flow-limiting dissection.\n* Inadequate treatment of proximal lesion (\\>30% residual stenosis).\n* Severe calcification of the target vessel \\[group 4 of Fanelli classification17 defined as circumferential calcification (270º-360º)\\], evidenced before contrast injection or digital subtraction angiography.\n* Thrombus in the target vessel.\n* Anastomotic stenosis of a bypass.\n* Use of atherectomy, thrombectomy, laser, or similar devices.\n* Prior or planned above-the-ankle amputation of the target limb.\n* Coagulopathy, hypercoagulable state, bleeding diathesis, platelets \\\u003C80 000\u002FµL or \\>700 000\u002FµL, or other blood disorder.\n* Gastrointestinal bleeding requiring transfusion within 3 months.\n* Contraindication to antiplatelet\u002Fanticoagulant\u002Fthrombolytic therapy.\n* Acute coronary syndrome within 30 days.\n* Stroke or TIA within 90 days.\n* Hypersensitivity\u002Fcontraindication to nitinol.\n* Comorbidities precluding treatment or follow-up (per investigator).\n* Hypersensitivity\u002Fallergy to contrast not manageable medically.\n* Hypersensitivity\u002Fallergy to heparin, aspirin, paclitaxel, clopidogrel, or other antiplatelet\u002Fanticoagulant agents.\n* Contraindication to dual antiplatelet therapy.",{"count":82,"type":22},142,[84],"NA","The aim of this clinical trial is to determine whether vessel preparation with a non-compliant scoring balloon before drug-coated balloon (DCB) angioplasty provides superior procedural and clinical outcomes compared with vessel preparation using a non-compliant plain balloon in patients with chronic limb-threatening ischaemia (CLTI) undergoing femoropopliteal endovascular intervention.\n\nThe main questions the study aims to answer are:\n\n* Does non-compliant scoring balloon vessel preparation reduce the need for bailout stenting during the index procedure?\n* Does it improve primary patency after DCB angioplasty?\n* Does it improve clinically relevant outcomes such as wound healing, freedom from clinically driven target lesion revascularisation, limb salvage and health-related quality of life?\n* Does it provide procedural and economic advantages compared with non-compliant plain balloon vessel preparation?\n\nParticipants will be randomly assigned to undergo vessel preparation using either a non-compliant plain balloon or the DKutting™ non-compliant scoring balloon, followed by angioplasty with the Legflow XP™ drug-coated balloon. Patients will undergo clinical, duplex ultrasound and quality-of-life follow-up for 24 months.",[87,88,89,28],"Femoropopliteal Disease","Drug Coated Balloon","Critical Limb-Threatening Ischaemia",[91,92,87,93,94,95,96,97,98],"Chronic Limb-Threatening Ischaemia (CLTI)","Peripheral Artery Disease (PAD)","Drug-Coated Balloon (DCB)","Vessel Preparation","Scoring Balloon","Non-Compliant Balloon","Primary Patency","Bailout Stenting","2026-08-12",{"date":101,"type":33},"2026-08-14",{"date":103,"type":22},"2026-12",{"date":105,"type":22},"2030-12",{"name":107,"class":108},"Marc Sirvent","OTHER",{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100450437","crush-pad-real-world-outcomes-following-use-of-shockwave-intravascular-lithotripsy-ivl-technology-in-calcified-common-femoral-lesions-100450437","NCT05145478","CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions","CTA_IIT_CRUSH PAD: Real-world Outcomes Following Use of the Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions","Inclusion Criteria:\n\n* Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limbs\n* Subject is a suitable candidate for angiography and endovascular intervention per the latest clinical guidelines\n* Patient is scheduled to undergo treatment with Shockwave Intravascular Lithotripsy (IVL) technology followed by standard of care treatment with DCB, BMS, DES at the physician's discretion.\n\nAngiographic Inclusion Criteria\n\n* Target lesion that is located in a native, de novo common femoral artery\n* Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.\n* Target lesion is ≥70% stenosis by investigator via visual estimate.\n* Target lesion length is ≤50mm for lesions 70-99% stenosed. Target lesion can be all or part of the 50mm treated zone.\n* Chronic total occlusion, lesion length is ≤50mm of the total ≤50 mm target lesion.\n* Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending \\> 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is \\\u003C50mm in length.\n\nExclusion Criteria:\n\n* Subjects with any medical condition that would make him\u002Fher an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.\n* Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.\n* Cognitive impairment as documented in medical records\n* Not speaking English or Spanish\n* Currently a prisoner\n* Pregnancy or nursing\n* Estimated survival less than 12 months at the time of screening\n* Prior history of CFA endarterectomy",{"count":117,"type":22},50,"OBSERVATIONAL","The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.",[121,28,122,123],"Femoral Arterial Calcification","Claudication","Critical Limb Ischemia",[125],"Peripheral Artery Disease",{"date":101,"type":33},{"date":128,"type":33},"2021-12-01",{"date":130,"type":22},"2027-06-01",{"name":132,"class":108},"Yale University",2,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100604025","evero-drug-coated-balloon-dcb-randomized-trial-100604025","NCT07144150","EVERO Drug-coated Balloon (DCB) Randomized Trial","Advance Evero™ 18 Everolimus-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Versus Paclitaxel-coated Ballons in Patients With Femoropopliteal Disease (EVERO Trial)","Inclusion Criteria:\n\n1. Documented PAD with Rutherford classification 2 - 4; and\n2. De novo or restenotic (non-stented) target lesion located in the native superficial femoral artery (SFA), popliteal artery (P1 or P2), or both native SFA and popliteal arteries.\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria\n\n1. Less than 18 years old;\n2. Inability or refusal to give informed consent by the patient or legally authorized representative;\n3. Life expectancy ≤ 12 months, per investigator assessment;\n4. Pregnant (or if absence of pregnancy is not verified by negative pregnancy test within 7 days of planned procedure), lactating, planning to become pregnant within 12 months of the planned procedure, or unwilling to use contraception for 12 months following the planned procedure;\n5. Unable or unwilling to comply with the follow-up schedule; or\n6. Simultaneously participating in another investigational drug or device study unless the patient is at least 30 days beyond the primary endpoint of any previous study.",{"count":142,"type":22},410,[84],"The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero drug-coated balloon \\[DCB\\]) in the treatment of the femoropopliteal artery lesions in patients with peripheral arterial disease (PAD). Specifically, the Randomized-Controlled Trial (RCT) is designed to demonstrate non-inferior safety and non-inferior effectiveness of the Evero DCB when compared to commercially available paclitaxel DCBs (pDCBs).",[146,28],"Peripheral Vascular Disease",[148,149,150,151,152,153,154,155,156],"Intermittent claudication","Paclitaxel","Everolimus","Rapamycin","Drug-coated balloon (DCB)","Percutaneous transluminal angioplasty (PTA)","Femoropopliteal artery","Superficial femoral artery (SFA)","Popliteal artery","2026-08-11",{"date":99,"type":33},{"date":160,"type":33},"2026-04-17",{"date":162,"type":22},"2032-10",{"name":164,"class":40},"Cook Research Incorporated",8,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":18,"minAge":172,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":174,"conditions":175,"keywords":186,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"100618724","case-specific-health-care-professional-clinical-survey-of-liberant-thrombectomy-system-100618724","NCT07335341","Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System","Patient case selection to be included in the clinical assessment will be specific to Liberant and will be made according to the following criteria:\n\n1. Patient treated is age ≥ 22 years at the time of procedure\n2. Use of Liberant in accordance with the device labeling within 72 hours of index procedure","22 Years",{"count":117,"type":22},"The purpose of Case-Specific Health Care Professional (HCP) Clinical Survey of Liberant™ Thrombectomy System, also known as the Liberant Clinical Assessment, is to collect first-in-human clinical data to confirm the safety and performance of the Medtronic Liberant™ thrombectomy system when used for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems",[176,177,178,179,180,181,182,28,183,184,185],"Venous Embolism of Lower Extremities (Diagnosis)","Arterial Embolism and Thrombosis","Acute DVT of Lower Extremity","Chronic DVT of Lower Extremity","DVT","Deep Vein Thrombosis Leg","Thrombus in the Peripheral Venous Vasculature","Acute Limb Ischemia","Lower Extremity Acute Limb Ischemia","LE ALI",[187,188,189,190,191,192,193,194,195,28,196,197,198,199,200,201],"Thrombus in Peripheral Arterial Systems","Thrombectomy","Thrombosis","Venous Thrombosis","Aspiration Thrombectomy","Percutaneous Mechanical Thrombectomy","Arterial Occlusive Diseases","Vascular Diseases","Peripheral Vascular Diseases","Mechanical Thrombectomy","Aspiration","Liberant Thrombectomy System","adverse events","Excipio","Thrombus in Peripheral Venous Systems","2026-08-07",{"date":157,"type":33},{"date":205,"type":33},"2026-02-24",{"date":207,"type":22},"2026-10",{"name":209,"class":40},"Medtronic Endovascular",4,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":4},"100649371","linematrix-biological-vascular-graft-for-infra-renal-arterial-bypass-or-replacement-100649371","NCT07733076","LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement","A Preliminary Study to Evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement","Inclusion Criteria:\n\n* 1.Adults aged ≥18 and ≤80 years, inclusive;\n* 2.Patients evaluated by the investigative staff as requiring infra-renal arterial bypass or arterial replacement, including but not limited to: ischemia, infection, trauma, arterial rupture;\n* 3.For ischemic limbs requiring infra-inguinal arterial bypass, Rutherford stage 3-6; Ankle-Brachial Index (ABI) ≤0.6; Preoperative imaging showing at least one below-knee artery vessel patent to the ankle with good runoff; No whole-segment healthy great saphenous vein available;\n* 4.Patients who are able to communicate effectively with investigative staff, competent and willing to give written informed consent, and are able to comply with entire study procedures including all scheduled follow-up visits.\n\nExclusion Criteria:\n\n* 1.Distal target artery diameter \\\u003C2.5mm;\n* 2.Known or suspected allergy to contrast media, anticoagulant\u002Fantiplatelet drugs, alcohol, or bovine-derived products;\n* 3.Hemoglobin \\\u003C60g\u002FL, platelet count \\\u003C60×10⁹\u002FL;\n* 4.Left ventricular ejection fraction \\\u003C30%;\n* 5.Severe cardiac disease: including New York Heart Association (NYHA) Scale III-IV severe heart failure, or a history of myocardial infarction, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina within 3 months;\n* 6.Stroke within 3 months prior to study entry;\n* 7.Uncontrolled or poorly controlled diabetes (preoperative glycated hemoglobin \\>10%);\n* 8.Active inflammatory vascular disease;\n* 9.Patients with autoimmune diseases or currently receiving immunosuppressive drug therapy;\n* 10.Active malignancy or other severe systemic disease with life expectancy less than 12 months;\n* 11.History of heparin-induced thrombocytopenia type II (HIT-II) or other contraindications to heparin use;\n* 12.AST or ALT \\>2× the upper limit of normal;\n* 13.Coagulation abnormalities (APTT or PT \\>1.5× upper limit of normal);\n* 14.Severe psychiatric disorders that interfere with study compliance;\n* 15.Pregnant or breastfeeding female, intending to become pregnancy, or could not use a highly effective method of birth control during the study period;\n* 16.Patients in another drug or medical device clinical trials has not yet been enrolled before enrollment;\n* 17.There are other factors that deemed unsuitable for study participation by the investigator.","80 Years",{"count":220,"type":22},15,[84],"Single center, single arm study to evaluate the Safety and Efficacy of LineMatrix® Biological Vascular Graft for Infra-renal Arterial Bypass or Replacement",[28],"2026-07-28",{"date":226,"type":33},"2026-07-30",{"date":228,"type":22},"2026-09-30",{"date":230,"type":22},"2028-09-30",{"name":232,"class":108},"Shanghai Zhongshan Hospital",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":18,"minAge":240,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":244,"conditions":245,"keywords":252,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":4},"100648515","heartmate-app-based-remote-monitoring-for-cardiovascular-risk-factor-management-100648515","NCT07721584","HeartMate App-Based Remote Monitoring for Cardiovascular Risk Factor Management","Effect of HeartMate Application-Based Remote Patient Monitoring on Cardiovascular Risk Factor Management: An Exploratory Randomized Controlled Pilot Study","Inclusion Criteria:\n\n1. Adults aged 19 years or older\n2. Patients with cardiac disease judged to require cardiac rehabilitation (e.g., heart failure, valvular heart disease, coronary artery disease, peripheral arterial disease)\n3. Able to be followed for at least 6 weeks during the study period\n4. Able to consent to blood testing and PPG measurement at baseline and endpoint\n5. Able to use a smartphone application\n\nExclusion Criteria:\n\n1. Judged unable to undergo PPG measurement\n2. Atrial fibrillation\n3. Condition or disease making participation in cardiac rehabilitation difficult\n4. Psychiatric illness, cognitive impairment, or expected poor adherence that may affect study participation","19 Years",{"count":242,"type":22},200,[84],"This exploratory pilot randomized controlled trial evaluates whether a HeartMate application-based remote patient monitoring (RPM) and digital cardiac rehabilitation program improves cardiovascular, functional, and psychological outcomes in patients with cardiac disease. A total of 200 participants with cardiovascluar disease requiring rehabilitation are randomly assigned in a 1:1 ratio to an intervention group or a control group. The intervention group uses the HeartMate app-based remote cardiac rehabilitation program for 6 weeks, including a daily heart check using smartphone remote photoplethysmography (rPPG), aerobic and resistance exercise, breathing training, and a cognitive-behavioral 'mind' program, with weekly remote coaching. The control group receives usual outpatient care and lifestyle education materials, with the app installed only for rPPG measurement so that digital-biomarker measurement is identical across groups. Clinical assessments (6-minute walk distance, grip strength, blood pressure, blood lipids and metabolic markers), questionnaires (SF-12, PHQ-9, GAD-7, KOSS-24), and digital biomarkers (rPPG-derived heart rate, heart rate variability, respiration, activity) are collected at baseline and at 6 weeks. The primary outcome is the between-group difference in the change in 6-minute walk distance from baseline to 6 weeks. Because this is an exploratory pilot, the results are intended to estimate the effect size and variance for a future definitive randomized controlled trial, and to assess the validity of digital biomarkers as well as the safety, feasibility, and adherence of the program.",[246,247,248,249,28,250,251],"Cardiovascular Diseases","Heart Failure, Systolic","Coronary Artery Disease","Heart Valve Diseases","Cardiac Rehabilitation","Cardiovascular Risk Factor",[246,253,248,254,28,250,251],"Heart Failure","Heart Valve Diseases;","2026-07-22",{"date":257,"type":33},"2026-07-23",{"date":259,"type":22},"2026-07-14",{"date":261,"type":22},"2028-08-31",{"name":263,"class":108},"Yonsei University",{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100648130","xpad-european-feasibility-study-100648130","NCT07716020","XPAD European Feasibility Study","Prospective, Non-randomized, European Feasibility Clinical Study to Assess the Safety and Performance of the Xeltis Peripheral Artery Disease (XPAD) Bypass Conduit.","Inclusion Criteria:\n\n1. Participants with peripheral artery occlusion who require elective lower-limb bypass surgery\n2. Participant has Rutherford grade 3 or 4 occlusive vascular disease and TASC C or D lesions.\n3. At least 18 years of age at screening\n4. Suitable anatomy while avoiding joints (assessed by a pre-procedural contrasted CT scan or previous angiogram assessed up to 90 days prior to baseline)\n5. Participant has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent\n6. Participant has been informed and agrees to pre- and post-procedure follow-up, including follow-up angiography\n7. Life expectancy of at least 24 months\n\nExclusion Criteria:\n\n1. Participant requires, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure.\n2. Stroke or myocardial infarction event within 6 weeks of the procedure or evidence of prior massive stroke (Modified Rankin Scale 3 or above)\n3. History of acute arterial occlusion requiring an emergent intervention within the last 12 months\n4. Severe chronic renal insufficiency (serum creatinine \\>2.5 mg\u002FdL) or undergoing hemodialysis\n5. Previous renal transplant\n6. Uncontrolled arterial hypertension (BP \\>200 mmHg) at 2 successive readings\n7. Uncontrolled or poorly controlled diabetes\n8. Abnormal blood values that could influence participant recovery and or\u002F graft hemostasis\n9. Reduced liver function, defined as: \\>2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) \\>1.5 or prothrombin time (PT) \\>18 seconds\n10. Any active local or systemic infection\n11. Known heparin- induced thrombocytopenia, active bleeding disorder and\u002For any coagulopathy or thromboembolic disease\n12. Allergies to study device (nitinol) or agents\u002Fmedication, such as contrast agents, aspirin or NOACs, that can't be controlled medically\n13. Previous enrolment in this study\n14. Participant is participating in another study\n15. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives\n16. Any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit\n\nIntra-operative exclusion criteria:\n\n1\\. Unsuitable anatomy to implant the XPAD conduit (e.g. target vessel diameter smaller than anticipated; severe calcification)",{"count":220,"type":22},[84],"A prospective, single arm, non-randomized European feasibility study to evaluate the safety and performance of the XPAD conduit in patients with peripheral arterial occlusive disease (PAOD), scheduled to undergo elective lower-limb, above or below the knee, bypass surgery.",[28],"2026-07-20",{"date":277,"type":33},"2026-07-21",{"date":103,"type":22},{"date":280,"type":22},"2032-12",{"name":282,"class":40},"Xeltis",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":18,"minAge":291,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":133},"100598791","phase-4-vascular-trial-associated-registry-pilot-100598791","NCT07076082","Vascular Trial Associated Registry Pilot","Vascular Trial Associated Registry Pilot: Antiplatelet Therapies for Patients Undergoing Lower Extremity Endovascular Revascularization","VSTAR-P","Inclusion Criteria:\n\n* Age greater than or equal to 45 at time of enrollment\n* Patient is scheduled for a PVI or has recently had a PVI in the last 30 days\n* Patient data is being submitted to Fivos, who is acting as the data collection subcontractor for the VQI-PVI registry.\n* Atherosclerotic vascular disease\n\nExclusion Criteria:\n\n* Patients who cannot consent for themselves\n* Allergy to Clopidogrel\n* Patients unable to stop clopidogrel for other medical reasons\n* Patients on dual pathway inhibition (DPI) with low dose rivaroxaban (2.5mg twice a day) that are unable to stop these medications\n* Allergy to aspirin\n* Nonatherosclerotic vascular disease\n* Patients undergoing open bypass at the same time as the peripheral transcutaneous angioplasty\n* Patients with high bleeding risk (HBR) defined as:\n\n  * History of major bleeding, active bleeding disorder, severe renal impairment (CrCl \\\u003C30), concurrent anticoagulation, platelet count \\\u003C100,000\n  * Recent stroke (within 6 months)\n  * Current warfarin therapy or full dose therapeutic direct oral anticoagulants (DOAC).\n* Patients unwilling or unable to comply with standard of care follow-up visits\n* Pregnant women\n* Prisoners","45 Years",{"count":293,"type":22},350,[295],"PHASE4","The purpose of this investigator-initiated, multicenter, open label, randomized trial is to evaluate 1 month vs. 6 months of dual antiplatelet therapy (DAPT) in patients undergoing lower extremity endovascular revascularization. We hypothesize that extending dual antiplatelet therapy (DAPT) to six months, compared to one month, will improve patency rates of target vessels following peripheral vascular intervention (PVI) without significantly increasing complications, particularly bleeding events.",[28],[299],"Peripheral Vascular Disease (PVD), Peripheral Vascular Intervention (PVI), Dual Antiplatelet therapy (DAPT), Peripheral Arterial Disease (PAD)","2026-07-15",{"date":302,"type":33},"2026-07-16",{"date":304,"type":33},"2025-10-15",{"date":306,"type":22},"2028-10-30",{"name":308,"class":108},"Corewell Health West",{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":329,"leadSponsor":331,"locationsCount":4},"100647153","phase-4-effect-of-secukinumab-on-cardiorenal-outcomes-in-patients-with-cardiorenal-metabolic-syndrome-and-atherosclerotic-cardiovascular-disease-100647153","NCT07704190","Effect of Secukinumab on Cardiorenal Outcomes in Patients With Cardiorenal Metabolic Syndrome and Atherosclerotic Cardiovascular Disease","A Prospective, Randomized, Open-Label, Parallel-Controlled Study to Evaluate the Efficacy and Safety of Targeted Interleukin-17A (IL-17A) Inhibitor (Secukinumab) on Cardiovascular and Renal Endpoints in Patients With Cardiorenal Metabolic Syndrome Complicated With Atherosclerotic Cardiovascular Disease","Inclusion Criteria:\n\n1. Age ≥ 18 years at screening.\n2. Meet at least one metabolic abnormality:\n\n   1. Body mass index ≥ 23 kg\u002Fm²;\n   2. Waist circumference ≥ 80 cm (female) or ≥ 90 cm (male);\n   3. Fasting glucose 100-124 mg\u002FdL (5.6-6.9 mmol\u002FL) or glycated hemoglobin (HbA1c) 5.7-6.4%;\n   4. Serum triglycerides ≥ 3.51 mmol\u002FL;\n   5. Documented hypertension, metabolic syndrome, or diabetes mellitus.\n3. Meet at least one diagnostic criterion for chronic kidney disease:\n\n   1. eGFR ≥15 and \\\u003C60 mL\u002Fmin\u002F1.73 m² (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] creatinine equation);\n   2. UACR ≥ 200 mg\u002Fg with eGFR ≥ 60 mL\u002Fmin\u002F1.73 m² and documented albuminuria.\n4. Have documented atherosclerotic cardiovascular disease (at least one):\n\n   1. Coronary heart disease: history of myocardial infarction, prior coronary revascularization, or ≥50% major epicardial coronary artery stenosis confirmed by cardiac catheterization or coronary coronary computed tomography angiography (CTA);\n   2. Cerebrovascular disease: prior atherosclerotic stroke, prior carotid revascularization, or ≥50% carotid artery stenosis confirmed by imaging;\n   3. Symptomatic peripheral artery disease.\n5. Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Clinical evidence or suspected active infection judged by investigators.\n2. History of myocardial infarction, stroke, transient ischemic attack, or hospitalization for unstable angina within 60 days prior to randomization.\n3. Planned coronary, carotid, or peripheral artery revascularization at randomization.\n4. Major cardiac surgery, non-cardiac major surgery, or major endoscopy within 60 days before randomization, or planned major surgery during the study period.\n5. Current use of systemic immunosuppressive agents (glucocorticoids, small-molecule immunosuppressants, biologic DMARDs, anti-tumor drugs).\n6. Long-term intermittent hemodialysis or peritoneal dialysis.\n7. History or confirmed evidence of active tuberculosis.\n8. History of inflammatory bowel disease.\n9. Active malignancy or carcinoma in situ within the past 5 years.\n10. Uncontrolled hypertension (systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg).\n11. Chronic heart failure classified as New York Heart Association (NYHA) Class IV.\n12. History of bone marrow or solid organ transplantation, or planned organ transplantation during the study.\n13. Known or suspected allergy to secukinumab or related excipients.\n14. Pregnant, lactating females, or females of childbearing potential without adequate effective contraception.\n15. Absolute neutrophil count \\\u003C2 ×10⁹\u002FL or platelet count \\\u003C120 ×10⁹\u002FL, or alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST) \\>2.5 × upper limit of normal.\n16. HbA1c ≥10% (≥86 mmol\u002Fmol).\n17. Any disease condition that may endanger subject safety or impair protocol compliance per investigator judgment.\n18. Subjects with inadequate standard therapy judged by investigators.",{"count":317,"type":22},100,[295],"This is a prospective, randomized, open-label, parallel-controlled clinical trial to evaluate the efficacy and safety of targeted IL-17A inhibition with secukinumab on cardiovascular and renal endpoints in 100 patients with cardiorenal metabolic syndrome and atherosclerotic cardiovascular disease (ASCVD). Eligible subjects will be randomized 1:1 to receive either secukinumab 75 mg subcutaneous injection every 4 weeks for a total of 12 weeks plus standard guideline-directed medical therapy, or standard medical therapy alone. The primary endpoint is the time to first occurrence of 3-point major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) over a 2-year follow-up period. Key indicators include estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR) for renal outcome assessment.",[321,322,323,248,324,325,28,326],"Cardiorenal Metabolic Syndrome","Atherosclerotic Cardiovascular Disease","Chronic Kidney Disease","Hypertension","Type 2 Diabetes Mellitus","Carotid Artery Stenosis",{"date":300,"type":33},{"date":300,"type":22},{"date":330,"type":22},"2028-12-31",{"name":332,"class":108},"Peking University Third Hospital",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":358},"100620152","intravascular-ultrasound-imaging-guidance-for-optimal-revascularization-of-limb-arteries-100620152","NCT07353905","Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries","INVIGOR","Inclusion Criteria:\n\n* Age ≥18 years\n* Symptomatic LE PAD - Rutherford Class 2-5\n* Angiographic evidence of \\>50% stenosis\n* Undergoing LE peripheral artery intervention\n* Target lesion is iliac, femoropopliteal, profunda or supramalleolar below-the-knee arteries (target lesions extending into the abdominal aorta and inframalleolar BTK may be included).\n\nExclusion Criteria:\n\n* Prior intervention at the target lesion within 6 months\n* Target lesion is abdominal aorta or inframalleolar BTK arteries",{"count":293,"type":22},[84],"This study will test whether using ultrasound imaging within blood vessels during minimally invasive treatment of leg arteries in patients with peripheral artery disease leads to better clinical outcomes.",[28,344],"Lower Extremity Arterial Disease",[346,347,348],"Intravascular Ultrasound","Angioplasty","Endovascular Treatment","2026-07-07",{"date":351,"type":33},"2026-07-09",{"date":353,"type":33},"2025-12-12",{"date":355,"type":22},"2028-07",{"name":357,"class":108},"Baylor Research Institute",6,{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":371,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":383},"100540802","the-golazo-peripheral-atherectomy-system-for-a-safe-and-effective-atherectomy-great-trial-100540802","NCT06321575","The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)","The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy","GREAT","General inclusion criteria:\n\n1. Age ≥18 years\n2. Candidate for atherectomy of the peripheral vasculature in the lower limbs\n3. Life expectancy \\>1 year in the opinion of the investigator\n4. Resting ankle brachial index (ABI) ≤0.90, or ≤0.75 after exercise. Subjects with non-compressible arteries shall have a toe brachial index (TBI) assessment.\n5. Target limb Rutherford clinical classification category 3 to 5\n6. Suitable candidate for angiography and endovascular intervention in the opinion of the investigator\n7. Willing and able to comply with the protocol-specified procedures and assessments\n8. Informed consent granted\n\n   Angiographic inclusion criteria:\n9. Target lesion(s) defined as stenosis ≥70% by angiographic visual estimation\n10. Total treated lesion length ≤20 cm by angiographic visual estimation\n11. Target reference vessel diameter (RVD) ≥2.0 mm and ≤4.5 mm by angiographic visual estimation\n12. Target limb will have a minimum of one patent (less than 50% stenosis) below the knee (BTK) vessel crossing the ankle, distal to any target lesion, providing perfusion to the foot at baseline\n\nGeneral exclusion criteria:\n\n1. Active infection in the target limb\n2. History of an endovascular procedure or open vascular surgery on the target limb within the last 30 days\n3. Planned surgical or interventional procedure within 30 days after the index procedure\n4. Lesion in the contralateral limb requiring intervention during the index procedure or within next 30 days\n5. Critical limb ischemia (CLI) with Rutherford clinical classification category 6\n6. Significant acute or chronic kidney disease with a GFR \\\u003C30 and\u002For requiring dialysis\n7. Acute myocardial infarction (non-ST-elevation myocardial infarction or ST-segment elevation myocardial infarction) or other uncontrolled comorbidity in the opinion of the investigator\n8. Myocardial infarction (MI) or stroke within two months of baseline evaluation\n9. Pregnant or lactating\n10. Subject is participating in another clinical investigation of a device, drug, or procedure that has not completed the study treatment or that clinically interferes with the endpoints of this study (post-approval registries are allowed as long as the investigator determines there is no clinical interference with study endpoints)\n11. Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy\n12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count \\\u003C125,000\u002Fmicroliter, known coagulopathy, or international normalized ratio (INR) \\>1.5\n13. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately medicated\n14. History of heparin-induced thrombocytopenia (HIT)\n15. Any thrombolytic therapy within two weeks of enrollment\n16. Target lesion(s) within a native vessel graft or synthetic graft\n17. Significant stenosis or occlusion of inflow not successfully treated before the index procedure\n18. Any evidence or history of intracranial or gastrointestinal bleeding or intracranial aneurysm\n19. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)\n20. One or more of the following complications of the foot:\n\n    1. Osteomyelitis that extends to the metatarsal bones.\n    2. Gangrene involving the plantar skin of the forefoot, midfoot or heel\n    3. Deep ulcer or large shallow ulcer (\\>3cm) involving the plantar skin of the forefoot, midfoot, or heel\n    4. Any heel ulcer with\u002Fwithout calcaneal involvement\n    5. Any wound with calcaneal bone involvement\n    6. Wounds that are deemed to be neuropathic or non-ischemic in nature\n    7. Wounds that require flap coverage or complete wound management for large soft tissue defect\n21. Congestive heart failure with a NYHA functional classification of III or higher\n\n    Angiographic exclusion criteria:\n22. More than 2 lesions to be treated with the investigational device; lesions located within 3 mm may be considered a single tandem lesion\n23. Clinical\u002Fangiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of the investigational device\n24. In-stent restenosis within the target lesion(s)\n25. Potentially unstable or flow-limiting dissection, type C or greater\n26. Clinical\u002Fangiographic evidence of distal embolization\n27. Inability to cross the proximal lesion vessel lumen with a guidewire (not subintimal)",{"count":41,"type":22},[84],"The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 20 investigational sites in the U.S.",[28],[372,373],"Symptomatic Infrainguinal Peripheral Arterial Disease","Endovascular Intervention","2026-07-02",{"date":376,"type":33},"2026-07-06",{"date":378,"type":33},"2024-06-20",{"date":380,"type":22},"2026-11",{"name":382,"class":40},"Avantec Vascular",20,{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":391,"enrollmentInfo":392,"targetDuration":393,"studyType":118,"phases":4,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":405},"100557901","use-of-thermal-imaging-camera-to-assess-perfusion-before-and-after-vascular-intervention-100557901","NCT06544135","Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention","TIC","Inclusion Criteria:\n\n* Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI.\n* Planned lower extremity endovascular intervention\n\nExclusion Criteria:\n\n* Non-arterial ulcers\n* Pregnant","99 Years",{"count":7,"type":22},"1 Year","This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.\n\nThe main question this study aims to answer is:\n\n\\- Are temperature measurements from a forward looking infrared (FLIR) camera of the lower extremity useful in predicting outcome of revascularization procedures?",[28,123,396],"Critical Lower Limb Ischemia","2026-07-01",{"date":374,"type":33},{"date":400,"type":33},"2025-04-14",{"date":402,"type":22},"2027-10",{"name":404,"class":108},"University Hospitals Cleveland Medical Center",3,{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":419,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":72},"100423929","adapted-physical-activity-in-patients-with-lower-limb-peripheral-arterial-disease-100423929","NCT04800276","Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease","Adapted Physical Activity in Patients With Lower Limb Peripheral Arterial Disease (ACTIV'AO)","ACTIV'AO","Inclusion Criteria:\n\n* Patient with Lower Limb Peripheral Arterial Disease with IPSC \\\u003C 0.90, arterial stenosis in the lower limbs and intermittent claudication\n* No contraindication to physical activity\n* Socially insured patients over 18 ;\n* Patient who has signed the consent form.\n\nExclusion Criteria:\n\n* Severe or unstable cardiopulmonary pathologies, contraindicating exercise training\n* Unstable angina or myocardial infarction \\\u003C3 months\n* Severe rheumatological pathology of the lower limbs\n* Amputee of a lower or upper limb fitted with a device\n* Extensive dermatosis of the lower limbs\n* Known NYHA grade III or IV heart failure\n* Known severe respiratory pathology\n* Parkinson's disease, hemiplegia or paraplegia\n* Adults subject to enhanced protection, deprived of their liberty by judicial or administrative decision\n* Persons unable to consent\n* Be in a period of exclusion from other interventional research.\n* Any event (injury, surgery, etc.) occurring during the protocol period that could have an impact on results.",{"count":415,"type":22},70,[84],"The prevalence of peripheral arterial disease is 12.2% in France. Intermittent claudication is the most common symtom of this disease. During physical exercise, such as walking, blood oxygen (O2) requirements increase. The development of atherosclerosis in the lower limbs, causes narrowing of the arteries and limits the increase in blood flow required for muscular effort. Patients then experience muscle pain, the intensity of which gradually increases until it forces them to stop. After stopping, the pain subsides and disappears in less than 10 minutes.\n\nThe location of the pain (calves and\u002For thighs and\u002For buttocks) is related to the location of the ischemia (distal in the calf, proximal in the thigh or buttock, or proximo-distal if several locations). This can have different consequences on the biomechanical parameters of walking and muscle activity. To date, the impact of this localization on physical capacity has never been studied.\n\nThese limitations are very disabling and impact the quality of life of patients.\n\nIn addition, poor lower limb performance is associated with higher mortality. Reducing symptomatology and improving functional abilities is therefore a major issue in patients with peripheral arterial disease. This can be achieved through the practice of an Adapted Physical Activity, an essential recommendation in the care of patients with peripheral arterial disease.\n\nOur main hypothesis is that the physical activity rehabilitation protocol \"Activ'AO\" will improve the functional capacities of patients with peripheral arterial disease who have followed the program with the localization of ischemia with a greater consideration than in patients in the group following a \"standard\" APA protocol. Improvements in functional abilities (such as walking) will lead to improvements in quality of life.",[28],[28,420,421],"Adapted Physical Activity","maximum walking distance","2026-06-30",{"date":397,"type":33},{"date":425,"type":33},"2021-02-11",{"date":427,"type":22},"2026-11-11",{"name":429,"class":108},"Centre Hospitalier le Mans",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":440,"conditions":441,"keywords":444,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":452,"locationsCount":72},"100644498","predictors-of-major-adverse-limb-events-after-endovascular-iliac-stenting-a-real-world-cohort-study-100644498","NCT07672249","Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study","Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study (PREMISE-ILIAC Study)","PREMISE-ILIAC","Inclusion Criteria:\n\nAdult patients aged ≥18 years, of both male and female sex\n\n* Presence of haemodynamically significant stenosis or occlusion of the common iliac artery (CIA) and\u002For external iliac artery (EIA), documented by computed tomography angiography, magnetic resonance angiography, or diagnostic angiography\n* Symptomatic peripheral artery disease, including lifestyle-limiting intermittent claudication (Rutherford category 2-3) or chronic limb- threatening ischaemia (CLTI; Rutherford category 4-6), refractory to optimal medical therapy\n* Treatment with endovascular iliac artery stenting (covered or uncovered; balloon-expandable or self-expanding devices) as the primary revascularisation strategy\n* De novo iliac lesions only\n* Availability of complet\n\nExclusion Criteria:\n\nPrimary open surgical revascularisation of the iliac axis (e.g., aorto- bifemoral bypass or endarterectomy).\n\n* Previous stenting of the target iliac segment (in-stent restenosis cases excluded).\n* Aorto-iliac aneurysmal disease as the primary indication for treatment (including EVAR or fenestrated endografts).\n* Hybrid procedures with concomitant infrainguinal bypass surgery.\n* Incomplete clinical, procedural, or follow-up data preventing assessment of study endpoints.\n* Loss to follow-up without documented clinical outcomes.",{"count":439,"type":22},98,"Peripheral arterial disease involving the iliac arteries is a common manifestation of systemic atherosclerosis and a major cause of lifestyle-limiting claudication and chronic limb-threatening ischemia. Endovascular iliac artery stenting has become the preferred treatment strategy for most iliac lesions, including complex TransAtlantic Inter-Society Consensus II (TASC II) C and D lesions, owing to high technical success rates and lower perioperative morbidity compared with open surgical reconstruction.\n\nDespite widespread adoption of endovascular treatment, available evidence regarding predictors of major adverse limb events (MALE) after iliac artery stenting remains limited, particularly in unselected real-world populations with substantial comorbidity burden. Patient-related factors, including frailty, may contribute to post-procedural outcomes in addition to lesion-related characteristics.\n\nThis retrospective single-center cohort study will evaluate clinical outcomes following endovascular iliac artery stenting in consecutive adult patients treated at IRCCS Galeazzi-Sant'Ambrogio Hospital, Milan, Italy. The study will assess the occurrence of major adverse limb events (MALE), primary patency, peri-procedural complications, target lesion revascularization, restenosis or occlusion, and all-cause mortality. Clinical, anatomical, and procedural factors associated with adverse limb outcomes, including frailty assessed by the modified five-item Frailty Index (mFI-5), will also be investigated.",[28,442,443,59],"Aortoiliac Occlusive Disease","Chronic Limb-Threatening Ischemia",[28,445,446],"Iliac Artery Stenting","Endovascular Revascularization","2026-06-26",{"date":422,"type":33},{"date":450,"type":33},"2026-06-16",{"date":302,"type":22},{"name":453,"class":108},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio",{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":461,"sex":18,"minAge":19,"maxAge":462,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":465,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":477,"locationsCount":72},"100640367","phase-1-the-pharmacokinetics-and-pharmacodynamics-study-of-evategrel-cg-0255-besylateand-plavix-in-healthy-participants-100640367","NCT07619885","The Pharmacokinetics and Pharmacodynamics Study of Evategrel CG-0255 Besylate）and Plavix® in Healthy Participants","A Pivotal Comparative Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of CG-0255 Besylate and Plavix® in Healthy Participants","Inclusion Criteria:\n\n* Participants must be fully informed about the study, willing to participate, and sign the informed consent document prior to any procedure.\n* Healthy male and female participants, aged 18 to 55 years (inclusive) at time of signing informed consent form.\n* Body mass index (BMI) between 18 and 32 kg\u002Fm2 (inclusive) at screening and body weight between 45 and 120 kg (inclusive).\n* Smoking \\\u003C 10 cigarettes (10-20 mg of nicotine\u002Fmonth) or equivalent amount of nicotine products per month within 6 months prior to screening and agree to abstain from tobacco and\u002For nicotine products during the study.\n* Generally normal health, or abnormalities deemed non-clinically significant by the Investigator or designee based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests at the screening and at the admission.\n* For female participants,\n\n  1. Woman of child-bearing potential (WOCBP) must be non-pregnant and non-lactating, and must agree to use highly effective contraceptive methods and abstain from egg collection or donation from the screening period to 3 months after the last dose of the study treatment (CG-0255 Besylate or Plavix®). The male partner of a female participant also needs to use condoms during this period.\n  2. Woman of non-childbearing potential (WONCBP) must be post menopausal (spontaneous amenorrhea for at least 12 consecutive months prior to dosing) with confirmation by documented FSH levels ≥40 mIU\u002FmL; or surgically sterile (bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or bilateral tubal ligation) at least 3 months prior to dosing.\n* Male participants considered fertile must agree to not plan to father a child, not donate sperm and take effective contraceptive methods from the screening period to 3 months after the last dose of the study treatment. The female partner of a male participant also needs to use a highly effective contraceptive method during this period.\n* Male participants (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the screening period to 3 months after the last dose of the study treatment.\n* Participants must be able to communicate well with the Investigator or designee, as well as understand and adhere to the study's requirements.\n\nExclusion Criteria:\n\n* Difficulty with venous blood collection or a history of fainting upon seeing blood or needles.\n* Clinically relevant drug intolerance or allergy or known or suspected hypersensitivity to any component of CG-0255 Besylate or Plavix®, or other related drugs.\n* Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or 5 times half-life, whichever is longer) prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days (or 5 times half-life, whichever is longer) prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.\n* Current or unresolved digestive tract diseases (dyspepsia, gastroesophageal reflux, gastro-hemorrhage, or digestive tract ulcer disease) within the past 6 months, or frequent (\\> 1 time\u002Fweek) digestive tract symptoms including dysphagia, abdominal pain, abdominal distension, acid regurgitation, belching, hematemesis, bloody stool, anorexia, nausea, heartburn, and other symptoms that may increase the risk of bleeding, as determined by the Investigator or designee.\n* Any clinically significant diseases including but not limited to pulmonary, cardiovascular, gastrointestinal, hematological, endocrinological, immunological, dermatological, malignant diseases, mental and nervous systems, and other related diseases or any other condition at the discretion of the Investigator or designee.\n* History of previous or current active bleeding (such as intracranial hemorrhage, gastrointestinal hemorrhage, urethral hemorrhage, hemoptysis, vitreous hemorrhage, bleeding caused by stool and hemorrhoids), transient ischemic attack or stroke, abnormal bleeding (such as prolonged bleeding time after tooth extraction), presence of petechiae and\u002For ecchymosis on physical examination, or suspected vascular malformations (such as aneurysms or early-onset stroke, not exceeding the age limit specified in the inclusion criteria).\n* Hemoglobin \\\u003C120 g\u002FL for males and \\\u003C110 g\u002FL for females at screening.\n* Medication history of NSAIDs (including Aspirin) or other drugs that may affect coagulation function (e.g, oral anticoagulants) within 4 weeks before the screening.\n* Platelet count \\\u003C 120 × 10\\^9\u002FL at screening.\n* Laboratory measures with values above the 1.5 × upper limits of normal (ULN) and deemed clinically significant by the Investigator or designee for the alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST).\n* Clinically significant ECG abnormalities (QTcF interval ≥ 450 ms for male, ≥ 470 ms for female (Fridericia's Correction)) or vital signs abnormalities (systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 50 or over 90mmHg, HR less than 50 or over 100 bpm, or RR less than 10 or over 22 bpm) at screening.\n* Major surgery within 3 months prior to the first dose of study treatment or plans for surgery during the study.\n* Use of prescription, nonprescription or dietary supplements (e.g. food supplements and herbal supplements) within 14 days or 5 times the half life (whichever is longer) prior to the first dose of study treatment (excluding drug products without significant systemic absorption at the discretion of the Investigator or designee), or depot injection or implant within 3 months prior to first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily).\n* Vaccinated within 14 days prior to the first dose of study treatment or planned to be vaccinated during the study.\n* Consuming quinine containing products, including quinine water, tonic water bitter lemon, jello shots, any quinine preparations or Cinchona tree bark reparations (e.g., herbal medications containing Cinchona tree bark), and grapefruit or products containing grapefruit, or participants have engaged strenuous exercise or any other factors affecting drug absorption, distribution, metabolism and excretion within 7 days before the first dose of study treatment.\n* History of drug abuse within 1 year before screening, or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \\[PCP\\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.\n* Positive urine drug screen, urine cotinine test, or alcohol breath test at screening or at the admission.\n* Positive pregnancy test or lactating female participant at screening or at the admission.\n* Donation of plasma within 7 days prior to the first dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to the first dosing.\n* History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).\n* Known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.\n* Excessive drinking of tea, coffee, or caffeine-containing beverage (\\>600 mg\u002Fday) within 30 days before screening; intake of caffeine- or xanthine rich foods or drinks (e.g., coffee, tea, chocolate, cola drinks) within 48 hours prior to the first dose of study treatment, which may metabolize into caffeine or xanthine.\n* Positive screening for human immunodeficiency virus (HIV) antigen and antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening.\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin as calculated per CKD-EPI equation, at screening.\n* Use of any drugs known to induce or inhibit hepatic drug metabolism (including CYP2C19 inducers or inhibitors) within 30 days prior to the first study drug administration or 5 half-lives (whichever is longer) until the end of the study.\n* Participants deemed ineligible to participate in this study by the Investigator or designee.",true,"55 Years",{"count":464,"type":22},136,[54],"CG-0255 is a novel investigational prodrug of the active metabolite of Plavix®， but with different active metabolite conversion routes. This is a randomized, open-label and Plavix®-controlled study to compare the PK and PD of CG-0255 Besylate and Plavix® in healthy participants.",[468,469,470,28],"Acute Coronary Syndromes (ACS)","Recent Myocardial Infarction","Recent Stroke","2026-06-24",{"date":473,"type":33},"2026-06-29",{"date":475,"type":22},"2026-06",{"date":103,"type":22},{"name":478,"class":40},"Shanghai CureGene Pharmaceutical Co., Ltd.",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":461,"sex":18,"minAge":49,"maxAge":50,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":497,"locationsCount":72},"100540630","early-phase-1-impact-of-nrf2-activation-on-macrovascular-microvascular--leg-function--walking-capacity-in-peripheral-artery-disease-100540630","NCT06319339","Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease","Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease","Inclusion Criteria:\n\nPeripheral artery disease (PAD) participants:\n\n* Able to provide written informed consent\n* 50-75 years of age\n* Diagnosed as Fontaine stage II-III\n* History of exercise-induced claudication\n* Females must be postmenopausal (cessation of menses for \\> 24 months)\n* Normal renal function (serum creatinine-estimated glomerular filtration rate \\>= 60 mL\u002Fmin) or evidence of stable renal function within the last 6 months\n* Normal hepatic function (alanine transaminase \\\u003C 87.5 U\u002FL, alkaline phosphatase \\\u003C 260 U\u002FL, total bilirubin 1.8 mg\u002FdL) or evidence of stable hepatic function within the last 6 months\n* Complete blood count:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL, or evidence of stable blood counts within the last 6 months\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL, or evidence of stable blood counts within the last 6 months\n\nAge-matched control participants:\n\n* Able to provide written informed consent\n* 50-75 years of age\n* No evidence of peripheral occlusive disease (ankle-brachial index \\> 0.90)\n* Females must be postmenopausal (cessation of menses for \\> 24 months)\n* Normal renal function (serum creatinine-estimated glomerular filtration rate \\>= 60 mL\u002Fmin), or evidence of stable renal function within the last 6 months\n* Normal hepatic function (alanine transaminase \\\u003C 87.5 U\u002FL, alkaline phosphatase \\\u003C 260 U\u002FL, total bilirubin 1.8 mg\u002FdL ), or evidence of stable hepatic function within the last 6 months\n* Complete blood count:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count \\> 700 million lymphocytes\u002FL, or evidence of stable blood counts within the last 6 months\n\nExclusion Criteria:\n\nPeripheral artery disease (PAD) participants:\n\n* • Pain at rest and\u002For tissue loss due to PAD (Fontaine stage IV PAD)\n* Acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma\n* Limited walking capacity from conditions other than PAD\n* No physical exam to assess exercise limitations in the past year\n* Currently pregnant or nursing\n* Blood work and medical history NOT demonstrating:\n\n  * Normal renal function (serum creatinine-estimated glomerular filtration rate \\>\\> 60 mL\u002Fmin)\n  * Normal hepatic function (alanine transaminase 0-35 IU\u002FL, alkaline phosphatase 30-120 IU\u002FL, total bilirubin 2-17 micromoles\u002FL),\n* Diagnosis of multiple sclerosis or psoriasis\n* Diagnosis of gastrointestinal disorders (e.g., moderate IBS, Crohn's disease, etc.\n* Concomitant use of dimethyl fumarate\n* Hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY\n* Ulcers, gangrene, or necrosis of the foot (Fontaine stage IV PAD)\n* Complete blood count NOT within ranges:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL\n\nAge-matched control participants:\n\n* Positive diagnosis of PAD\n* No physical exam to assess exercise limitations in the past year\n* Any exercise limitations as determined at last physical exam\n* Limited walking capacity from musculoskeletal injury\n* Currently pregnant or nursing\n* Renal function not within normal ranges (serum creatinine-estimated glomerular filtration rate \\>\\> 60 mL\u002Fmin)\n* Hepatic function not within normal ranges (alanine transaminase 0-35 IU\u002FL, alkaline phosphatase 30-120 IU\u002FL, total bilirubin 2-17 micromoles\u002FL)\n* Complete blood count NOT within ranges:\n\n  * Females: red blood cell 4-5 trillion cells\u002FL, hemoglobin 12-15 g\u002FdL, hematocrit 34-45%, white blood cell count 3-10 billion cells\u002FL, platelet count 160-380 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL\n  * Males: red blood cell 4-6 trillion cells\u002FL, hemoglobin 13-17 g\u002FdL, hematocrit 38-49%, white blood cell count 3-10 billion cells\u002FL, platelet count 135-320 billion\u002FL, and normal lymphocyte count 1-4.8 billion lymphocytes\u002FL",{"count":383,"type":22},[488],"EARLY_PHASE1","Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. There will be a follow-up visit to assess blood work after diroximel fumarate.",[125,195,28,491],"Peripheral Arterial Occlusive Disease","2026-06-19",{"date":471,"type":33},{"date":495,"type":33},"2024-11-14",{"date":103,"type":22},{"name":498,"class":108},"University of Nebraska",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":508,"studyType":118,"phases":4,"briefSummary":509,"conditions":510,"keywords":514,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":528,"leadSponsor":530,"locationsCount":72},"100644229","effectiveness-of-an-inpatient-rehabilitation-and-prosthetic-training-model-in-patients-with-vascular-and-metabolic-transfemoral-amputation-100644229","NCT07665775","Effectiveness of an Inpatient Rehabilitation and Prosthetic Training Model in Patients With Vascular and Metabolic Transfemoral Amputation","Effectiveness of an Inpatient Multidisciplinary Rehabilitation and Prosthetic Training Model in Patients With Vascular and Metabolic Transfemoral Amputation Treated at a National Rehabilitation Center: An Ambispective Cohort Study","Inclusion Criteria:\n\n* Unilateral transfemoral amputation secondary to vascular disease or diabetes-related complications.\n* Participation in the INRLGII inpatient prosthetic rehabilitation program.\n* Availability of complete clinical records or willingness to participate in follow-up assessments .\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Current prosthesis user before admission to the INRLGII rehabilitation program.\n* Bilateral major lower-limb amputation.\n* Inability to complete follow-up assessments.\n\nWithdrawal Criteria\n\n* Incomplete or inconsistent clinical information.\n* Loss to follow-up during the 6-month observation period.\n* Participant withdrawal of consent.",{"count":507,"type":22},54,"6 Months","Patients with vascular and metabolic transfemoral amputations experience substantial functional limitations and high rates of prosthetic abandonment. Although multidisciplinary inpatient rehabilitation programs have been associated with improved outcomes, evidence regarding their effectiveness in low- and middle-income countries remains limited.\n\nThis study aims to evaluate the effectiveness of an inpatient rehabilitation and prosthetic training model implemented at the National Institute of Rehabilitation \"Luis Guillermo Ibarra Ibarra\" (INRLGII), Mexico. An ambispective cohort design will be used, including a retrospective review of patients treated between 2013 and 2025 and a prospective cohort enrolled between 2026 and 2029.\n\nThe primary objective is to determine the proportion of patients who achieve functional prosthesis use after hospital discharge. Secondary objectives include identifying clinical, metabolic, functional, and psychosocial factors associated with successful prosthetic use, adherence, and abandonment.",[511,512,28,513],"Diabetes Mellitus","Transfemoral Amputation","Vascular Thrombosis",[512,515,511,516,517,518,519,520,521,522,523,524],"Vascular Amputation","Prosthetic Rehabilitation","Lower Limb Amputation","Prosthesis Use","Prosthetic Adherence","Prosthetic Abandonment","Functional Outcomes","Inpatient Rehabilitation","Multidisciplinary Care","Houghton Scale","2026-06-18",{"date":471,"type":33},{"date":492,"type":22},{"date":529,"type":22},"2030-09",{"name":531,"class":532},"Instituto Nacional de Rehabilitacion","OTHER_GOV",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":539,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":541,"targetDuration":393,"studyType":118,"phases":4,"briefSummary":543,"conditions":544,"keywords":548,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":72},"100640402","radial-access-data-in-vascular-interventions-registry-100640402","NCT07614386","Radial Access Data in Vascular Interventions Registry","Radial Access Data in Vascular Interventions: A Prospective Observational Registry Study","RADIUS","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients undergoing routine percutaneous vascular interventions via radial or ulnar artery access\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Procedures performed without radial or ulnar artery access\n* Incomplete procedural or clinical data\n* Refusal to participate in the registry",{"count":542,"type":22},20000,"The RADIUS study is a prospective observational registry designed to collect real-world data regarding radial and ulnar artery access in percutaneous vascular interventions. The study aims to evaluate procedural characteristics, access-site complications, procedural success, and short-term clinical outcomes associated with transradial and transulnar vascular access.\n\nPatients undergoing routine percutaneous vascular interventions via radial or ulnar artery access at Mersin Medical Park Hospital will be consecutively enrolled. Demographic, clinical, angiographic, procedural, and post-procedural data will be prospectively collected and analyzed.\n\nThe study was initially designed as a single-center registry; however, following Institutional Review Board (IRB) approval, expansion into a multicenter registry with participating centers is planned.\n\nThis study is observational in nature and does not involve any experimental treatment, device, or intervention beyond standard clinical care.",[545,546,547,248,28],"Radial Artery Occlusion","Radial Artery Spasm","Vascular Access Complications",[549,550,551,552,553,554,555,546,556],"Radial access","Ulnar access","Transradial intervention","Coronary angiography","Percutaneous coronary intervention","Vascular complications","Radial artery occlusion","Registry",{"date":558,"type":33},"2026-06-23",{"date":560,"type":33},"2026-05-15",{"date":562,"type":22},"2031-05-20",{"name":564,"class":108},"Mersin Medicalpark Hastanesi",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":572,"enrollmentInfo":573,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":579,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":586,"leadSponsor":588,"locationsCount":72},"100641226","phase-3-evaluating-bu-yang-huanwu-decoction-for-early-diabetic-vascular-disease-100641226","NCT07658807","Evaluating Bu Yang Huanwu Decoction For Early Diabetic Vascular Disease","Evidence-Based Evaluation and New Drug Translation Research of Early Intervention With the Classic Traditional Chinese Medicine Formula Bu Yang Huanwu Decoction for Preventing and Treating Diabetic Lower Extremity Vascular Disease","Inclusion Criteria:\n\n1. Aged 18 to 70 years (inclusive), male or female.\n2. Diagnosed with diabetes mellitus according to the Chinese Diabetes Society (2024) Guidelines.\n3. Glycated hemoglobin (HbA1c) \\\u003C 12%, with recent fasting blood glucose \\\u003C 7.0 mmol\u002FL OR postprandial blood glucose \\\u003C 10.0 mmol\u002FL, and triglycerides \\\u003C 1.7 mmol\u002FL.\n4. Diagnosed with LEAD, meeting the following criteria:\n\n   Rutherford Classification 2, 3, or 4.\n\n   Resting ABI ≤ 0.90, OR for patients with exertional symptoms and resting ABI \\> 0.90, a post-exercise treadmill test showing an ABI decrease of ≥15%.\n\n   Evidence of lower limb arterial stenosis or occlusion confirmed by duplex ultrasound, CTA, MRA, or DSA.\n5. TCM Pattern Diagnosis: Must conform to the TCM syndrome of Qi Deficiency and Blood Stasis, as defined by the study's TCM diagnostic criteria (referencing \"Practical Diagnostic Criteria for Blood Stasis Syndrome\" and \"Integrated Chinese and Western Medicine Peripheral Vascular Disease\"):\n\n   Main Symptom: Lower limb weakness, or feeling of heaviness\u002Fdiscomfort after prolonged walking.\n\n   Secondary Symptoms: Shortness of breath\u002Flassitude in speaking; dry mouth with desire to drink; scaly skin.\n\n   Tongue \\& Pulse: Tongue with teeth marks, pale-purple with petechiae\u002Fecchymosis; thin and choppy pulse.\n\n   (Diagnosis confirmed by meeting 1 main symptom OR 2 secondary symptoms, assessed by a qualified TCM practitioner.)\n6. Voluntarily signs the Informed Consent Form (ICF) and is willing and able to comply with all study procedures and visits.\n\nExclusion Criteria:\n\n1. Known bleeding disorders or history of intracranial hemorrhage.\n2. Current use of anticoagulants (e.g., warfarin, dabigatran, factor Xa inhibitors).\n3. Presence of active infection.\n4. Severe cardiac abnormalities on resting ECG (e.g., heart failure, ventricular tachycardia, ventricular fibrillation, multifocal ventricular contractions, prolonged corrected QT interval).\n5. History of acute coronary syndrome ≤ 12 months requiring dual antiplatelet therapy.\n6. Chronic liver disease (Child-Turcote-Pugh score ≥5) or chronic kidney disease stages 4-5 (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²).\n7. History of malignancy (except cured basal cell carcinoma).\n8. Moderate to severe anemia, polycythemia vera, or any hyperviscosity syndrome.\n9. Planned lower limb revascularization or amputation.\n10. Concurrent or planned use of medicinal products containing Veratrum species.\n11. Pregnant or lactating women, or women of childbearing potential not using highly effective contraception.\n12. Known allergy or hypersensitivity to any component of the study medication (Qilong Capsules, aspirin).\n13. Patients with psychiatric disorders or judged to be uncooperative.\n14. Currently participating in another drug clinical trial or using therapies with similar purported effects.\n15. Any other condition deemed by the investigator to make the participant unsuitable for the trial.","70 Years",{"count":574,"type":22},300,[25],"The goal of this clinical trial is to learn if adding a Traditional Chinese Medicine formula, Bu Yang Huanwu Decoction (specifically the capsule form called Hua Yu Wan Capsule), to standard treatment can help prevent leg pain at rest or foot ulcers in people with diabetic lower extremity vascular disease. The main questions it aims to answer are:\n\nDoes adding Hua Yu Wan Capsule to standard treatment lower the chance of developing leg pain at rest or foot ulcers after one year, compared to standard treatment alone?\n\nIs the treatment combination safe for participants?\n\nResearchers will compare two groups:\n\nGroup 1 (Experimental): Standard treatment (including aspirin, and medicines for blood sugar and cholesterol control) plus Hua Yu Wan Capsule.\n\nGroup 2 (Control): Standard treatment alone.\n\nParticipants in this study will:\n\nBe adults aged 18 to 70 years with diabetes and early to moderate lower extremity vascular disease (confirmed by tests like the Ankle-Brachial Index or ABI).\n\nBe randomly assigned to one of the two treatment groups.\n\nTake their assigned treatment for 6 months.\n\nAttend clinic visits at 1, 3 and 6 months during treatment, and again at 6 and 12 months after treatment ends for check-ups and tests.",[28,578,193],"Diabetic Angiopathies",[28,61,580,581],"Medicine, Chinese Traditional","Randomized Controlled Trial","2026-06-15",{"date":584,"type":33},"2026-06-22",{"date":475,"type":22},{"date":587,"type":22},"2029-01",{"name":589,"class":108},"Xuanwu Hospital, Beijing",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":391,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":598,"briefSummary":599,"conditions":600,"keywords":601,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":608,"leadSponsor":610,"locationsCount":4},"100622588","a-single-arm-trial-to-evaluate-the-safety-and-efficacy-of-the-long--150mm-passeotm-18-luxtm-drug-coated-balloon-in-the-treatment-of-subjects-with-infrainguinal-stenotic-restenotic-or-occlusive-lesions-100622588","NCT07385573","A Single Arm Trial to Evaluate the Safety and Efficacy of the Long (> 150mm) PasseoTM-18 LuxTM Drug-coated Balloon in the Treatment of Subjects With Infrainguinal Stenotic, Restenotic or Occlusive Lesions","LUX-PAD","Inclusion Criteria\n\n* Study participant is ≥ 18 years and ≤ 99 years old\n* Lesion(s) in the infrainguinal arteries:\n\n  * Lesion above the knee (ATK): Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)\n  * Lesion below the knee (BTK): Target lesions involve arteries below the tibial plateau\n* RVD 2-7mm\n* De novo stenotic, restenotic post POBA, or occlusive lesion(s)\n* Target lesion must have angiographic evidence of ≥70% stenosis\n* Lesion length ≥ 3cm\n* Successful crossing of the target lesion with the guide wire\n* Successful predilatation, defined as residual stenosis \\\u003C50% Rutherford Class 2-5\n* Study participant is able to provide consent and has signed and dated the informed consent form\n\nExclusion criteria\n\n* Life expectancy ≤ 1 year\n* Study participant is currently participating in another investigational drug or device study that has not reached its primary endpoint yet.\n* Study participant is pregnant, planning to become pregnant, or father children during the course of the study.\n* Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion).\n* Prior bypass surgery of target vessel\n* Planned major amputation of the target limb\n* Thrombus in the target vessel\n* Known allergy to contrast media that cannot be adequately controlled with premedication\n* Study participant has a single target lesion that involves both ATK and BTK segments",{"count":242,"type":22},[84],"This clinical trial will evaluate the study device, Passeo®-18 Lux® paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of new or recurring cholesterol-related blockages in the arteries of the lower leg.\n\nThe device that is used in this trial has been assessed in several previous studies for safety and effectiveness. The device is already approved for use in Europe. It has a \"CE mark,\" which means it meets the European Union's safety, health and performance standards.\n\nThis trial is being done to gather additional information on how well the device works and how safe it is when used in everyday medical care with specific attention to the longer lengths of the balloon, as it comes in different sizes.",[88,28],[595,602,603],"Passeo-18 Lux Long","Passeo-18","2026-06-08",{"date":606,"type":33},"2026-06-09",{"date":475,"type":22},{"date":609,"type":22},"2032-01",{"name":611,"class":108},"KANDO Research",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":18,"minAge":619,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":23,"phases":622,"briefSummary":623,"conditions":624,"keywords":627,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":639,"leadSponsor":641,"locationsCount":72},"100640379","in-hospital-wearable-based-monitoring-versus-standard-care-in-cardiovascular-disease-inspire-100640379","NCT07622485","In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE)","In-Hospital Efficacy and Safety of Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease: A Stepped-Wedge Cluster Randomized Controlled Trial (INSPIRE Trial)","Inclusion Criteria:\n\nAdults aged 20 years or older\n\n* Hospitalized for cardiovascular disease, with at least one of: acute coronary syndrome; chronic coronary syndrome; acute heart failure (NYHA class III-IV or acute decompensated heart failure); arrhythmia (atrial fibrillation, ventricular tachycardia, complete AV block, or other clinically significant arrhythmia); peripheral arterial or aortic disease; post-cardiovascular-procedure observation (PCI, CABG, valve surgery, or electrophysiology study); or thromboembolic disease\n* Able to provide written informed consent\n* Able to wear the wearable monitoring device\n\nExclusion Criteria:\n\n* Hemodynamically unstable shock (sustained systolic blood pressure \\\u003C 90 mmHg requiring vasopressors; cardiogenic shock; septic shock)\n* Planned or current intensive care unit admission\n* Within 24 hours after cardiopulmonary resuscitation\n* Physical condition precluding device wearing (bilateral upper-limb amputation; severe skin lesion, burn, or open wound at the device site; known allergy to device materials)\n* Severe cognitive impairment or delirium precluding informed consent Extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) in use\n* Continuous renal replacement therapy (CRRT) in use (patients on CRRT may participate if hemodynamically stable and device wearing is technically feasible)\n* Unable to communicate in Korean for study explanation and the consent process\n* Previously enrolled in this study (re-admitted patients are not re-enrolled; each participant is enrolled only at the first admission)\n* Considered inappropriate for participation by the investigator","20 Years",{"count":621,"type":22},1500,[84],"Patients hospitalized with cardiovascular disease require timely detection of clinical deterioration to prevent adverse outcomes. Standard inpatient care relies on intermittent nursing vital-sign measurements performed every 4 to 8 hours, which can miss hemodynamic or arrhythmic events occurring between measurements. This trial evaluates whether digital wearable-based monitoring - wireless continuous measurement of vital signs and electrocardiography with a real-time alerting system - reduces major adverse cardiovascular events (MACE) compared with standard intermittent monitoring in patients hospitalized for cardiovascular disease. The trial uses a stepped-wedge cluster-randomized design in which four inpatient ward zones (clusters) are sequentially transitioned from standard care to wearable monitoring over five periods.",[246,625,253,626,28],"Acute Coronary Syndrome","Cardiac Arrhythmia",[628,629,630,631,632,633,634],"wearable device","continuous monitoring","remote monitoring","stepped-wedge cluster trial","major adverse cardiovascular events","digital health","inpatient monitoring","2026-06-01",{"date":637,"type":33},"2026-06-03",{"date":397,"type":22},{"date":640,"type":22},"2029-12-31",{"name":263,"class":108},{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":648,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":650,"targetDuration":4,"studyType":23,"phases":652,"briefSummary":653,"conditions":654,"keywords":656,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":666,"leadSponsor":668,"locationsCount":72},"100618804","shortwave-diathermy-in-home-treatment-for-indianapolis-va-only-patients-diagnosed-with-peripheral-artery-disease-and-peripheral-neuropathy-100618804","NCT07336381","Shortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy","An Exploratory Clinical Study Using the Replexa+ Device in Veterans With Lower Extremity Peripheral Artery Disease Experiencing Peripheral Neuropathy","Replexa+","Inclusion Criteria:\n\n1. Diagnosis of peripheral artery disease (PAD).\n2. Participants must exhibit PAD severity, defined by the following manifestation and corresponding Rutherford classifications:\n\n   Claudication of the index limb (Rutherford Category 2 or 3- documented as pain with walking) in conjunction with one or more of the following:\n   * ankle brachial index (ABI) greater than or equal to 0.6 mmHg, as measured no more than 6 months prior to screening\n   * resting toe brachial index (TBI) greater than or equal to 0.4, as measured no more than 6 months prior to screening\n\n   Note: In cases where ankle and toe systolic pressures are unavailable due to calcification and\u002For toe amputation, collection of angiographic data is acceptable to determine locations of blockages or reduced perfusion.\n3. Diagnosis of peripheral neuropathy, as evidenced by review of medical records.\n4. Competent to give consent.\n5. Age 18 years or older.\n\nExclusion Criteria:\n\n1. Impaired skin integrity in the location(s) to be treated.\n2. Current wounds or ulcerations.\n3. Diagnosis of active bleeding tendencies, hemorrhage, or thrombosis.\n4. 2+ pitting edema in either lower extremity.\n5. Active infection defined as elevated white blood cell count \\>11,500\u002FµL or fever \\>101.5 degrees Fahrenheit or currently taking antibiotic medication(s) for an active infection.\n6. Existence of metal hardware in the area(s) to be treated: Any patient with implanted electronic or metal device such as a pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, IUD, surgical staples or implanted metallic leads.\n7. Pregnant individuals.\n8. Presence of renal disease (creatinine \\> 2.5 mg\u002Fdl and estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin) or patients on chronic hemodialysis.\n9. History of skeletal tuberculosis.\n10. Patients, in the investigator's opinion, whose index limb condition is rapidly deteriorating and may require major amputation within 30 days of screening.\n11. Conditions that impair cognitive function.\n12. Severe concomitant disease(s), or any additional condition(s) which the investigator feels constitute(s) criteria for exclusion of a particular subject.",{"count":651,"type":22},10,[84],"This research project is designed to see if treatment with the Replexa+ shortwave diathermy device daily for 3 months will improve blood flow in the lower legs and feet of patients diagnosed with peripheral artery disease and peripheral neuropathy.",[28,655],"Peripheral Neuropathy",[657,658,659,660,661],"peripheral artery disease","peripheral neuropathy","lower extremity artery disease","lower extremity neuropathy","PAD","2026-05-27",{"date":664,"type":33},"2026-05-29",{"date":397,"type":22},{"date":667,"type":22},"2027-12-31",{"name":669,"class":108},"Indiana University",{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":674,"acronym":4,"eligibilityCriteria":675,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":676,"targetDuration":4,"studyType":23,"phases":678,"briefSummary":679,"conditions":680,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":690},"100501600","the-gore-vbx-forward-clinical-study-a-comparison-of-the-gore-viabahn-vbx-balloon-expandable-endoprosthesis-to-bare-metal-stenting-for-patients-with-complex-iliac-occlusive-disease-100501600","NCT05811364","The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease","Inclusion Criteria:\n\n* Age ≥ 18 years at time of informed consent signature\n* Informed Consent Form (ICF) is signed by the subject\n* Subject can comply with protocol requirements, including follow-up\n* Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)\n* Patient has de novo or restenotic lesion(s) found in the common and\u002For external iliac artery(ies)\n* Patient has: Unilateral or bilateral single or multiple lesions (\\>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length\n* Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm\n* Patient has a sufficient (\\\u003C50% stenotic) common femoral artery and at least one sufficient (\\\u003C50% stenotic) femoral artery (deep or superficial).\n* Patient has at least one sufficient (\\\u003C50% stenotic) infrapopliteal run-off vessel.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year\n* Patient is pregnant at time of informed consent.\n* Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).\n* Patient has severe chronic renal insufficiency (serum creatinine level \\> 2.5mg\u002FdL) and not undergoing hemodialysis.\n* Patient has evidence of a systemic infection.\n* Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.\n* Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).\n* Patient has previous stenting in the iliac arteries.\n* Patient has previous surgical bypass in the target limb.\n* Patient is currently participating in another investigative clinical study unless received written approval by the sponsor.\n* Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery.\n* Patient has an abdominal aortic artery lesion or aneurysm.\n* Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament.\n* Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery).\n* Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral \u002F tibial revascularization).",{"count":677,"type":22},244,[84],"The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.",[442,28],"2026-05-11",{"date":683,"type":33},"2026-05-13",{"date":685,"type":33},"2023-10-17",{"date":687,"type":22},"2032-01-31",{"name":689,"class":40},"W.L.Gore & Associates",43]