[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"femoropopliteal-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:femoropopliteal-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100651640","dcb-outcomes-after-non-compliant-balloon-vessel-preparation-with-or-without-scoring-in-patients-with-femoropopliteal-arterial-disease-100651640",false,"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.","ALL","18 Years",{"count":20,"type":21},142,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Femoropopliteal Disease","Drug Coated Balloon","Critical Limb-Threatening Ischaemia","Peripheral Arterial Disease",[32,33,27,34,35,36,37,38,39],"Chronic Limb-Threatening Ischaemia (CLTI)","Peripheral Artery Disease (PAD)","Drug-Coated Balloon (DCB)","Vessel Preparation","Scoring Balloon","Non-Compliant Balloon","Primary Patency","Bailout Stenting","NOT_YET_RECRUITING","2026-08-12",{"date":43,"type":44},"2026-08-14","ACTUAL",{"date":46,"type":21},"2026-12",{"date":48,"type":21},"2030-12",{"name":50,"class":51},"Marc Sirvent","OTHER",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100614646","evaluation-of-the-clinical-outcomes-of-the-embolic-protection-system-in-preventing-distal-embolism-during-femoropopliteal-debulking-procedures-100614646","NCT07282301","Evaluation of the Clinical Outcomes of the Embolic Protection System in Preventing Distal Embolism During Femoropopliteal Debulking Procedures","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Rutherford classification 2-5\n3. Patients with chronic femoropopliteal obstruction or thromboembolism who require debulking prior to other endovascular treatments.\n4. Patients who understand the purpose of this study, participate in the study voluntarily, sign the informed consent and are willing to receive follow-up visits\n5. The guidewire needs to pass through the lesion\n6. Life expectancy \\>24 months\n7. Moderate to severe calcified lesions confirmed by imaging\n8. For patients who receive intervention in both lower extremities, they may be enrolled in order of time of endovascular therapy\n9. For combined aortoiliac artery lesions, recanalization of blood flow through endoluminal reconstruction of the vessel without more than 50% residual stenosis.\n\nExclusion Criteria:\n\n1. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or cardiac infarction within 3 months prior to enrollment\n2. Patients with known allergy to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.\n3. Patients who have been treated with drugs that interfere with this clinical trial or intraoperatively with other special vascular bed preparation devices, such as plaque volume reduction devices, special balloons, etc., within the last 3 months;\n4. Pregnant and lactating women\n5. Patients who are unable or unwilling to participate in this trial\n6. patients with Berger's disease\n7. Patients who have undergone arterial bypass on the treated side",{"count":59,"type":21},150,"OBSERVATIONAL","Patients with femoropopliteal arterial lesions requiring debulking procedures. The objective of this study is Evaluation of the clinical outcomes of the Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures (The EPISODE study).",[27],[64,65,66],"Embolic Protection System","Distal embolism","Debulking","RECRUITING","2025-12-02",{"date":70,"type":44},"2025-12-15",{"date":72,"type":44},"2025-10-20",{"date":74,"type":21},"2026-12-31",{"name":76,"class":51},"RenJi Hospital",1]