[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651640":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":36,"centralContacts":37,"locations":36,"responsibleParty":44,"collaborators":48,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":36,"enrollmentInfo":64,"targetDuration":36,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":85,"whyStopped":36,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":36},{"fullName":5,"class":6},"Hospital de Granollers","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-compliant plain balloon (PBA)","ACTIVE_COMPARATOR","* Vessel preparation using non-compliant plain balloon\n* Definitive treatment: drug-coated balloon angioplasty (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany).",[13],"Device: Non-compliant Plain Balloon angioplasty (PBA)",{"label":15,"type":10,"description":16,"interventionNames":17},"Scoring balloon (SB)","* Vessel preparation using non-compliant scoring balloon (DKutting™; Manufacturer: DK Medical Technology Co., Ltd., Suzhou, China)\n* Definitive treatment: drug-coated balloon angioplasty (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany) as definitve treatment.",[18],"Device: Non-compliant Scoring Balloon Angioplasty (SB)",[20,28],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Non-compliant Plain Balloon angioplasty (PBA)","The intervention consists of preparing the artery with a non-compliant plain balloon before using the DCB (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany).",[9],[26,27],"Control group","Group 0",{"type":21,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Non-compliant Scoring Balloon Angioplasty (SB)","The intervention consists of preparing the artery with a non-compliant scoring balloon (DKutting™; Manufacturer: DK Medical Technology Co., Ltd., Suzhou, China) before using the DCB (Legflow XP™; Manufacturer: Cardionovum GmbH Bonn, Germany) as definitve treatment.",[15],[33,34,35],"Treatment group","Intervention group","Group 1",null,[38],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Marc Sirvent, PhD","CONTACT","+34938425000","2575","msirvent@fphag.org",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Marc Sirvent","PhD, MD, FEBVS, Head of the Department of Angiology and Vascular Surgery, Hospital General de Granollers",[49,52],{"name":50,"class":51},"DK Medical Technology (Suzhou) Co., Ltd.","INDUSTRY",{"name":53,"class":51},"Cardionovum GmbH","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":65,"type":66},142,"ESTIMATED","INTERVENTIONAL",[69],"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.",[72,73,74,75],"Femoropopliteal Disease","Drug Coated Balloon","Critical Limb-Threatening Ischaemia","Peripheral Arterial Disease",[77,78,72,79,80,81,82,83,84],"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":88,"type":89},"2026-08-14","ACTUAL",{"date":91,"type":66},"2026-12",{"date":93,"type":66},"2030-12",{"name":46,"class":6}]