[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Marc Sirvent\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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",""]