[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624182":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":26,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DCB","ACTIVE_COMPARATOR","Participants in this group will be received drug-coated balloon angioplasty",[13],"Device: paclitaxel-coated balloon angioplasty",{"label":15,"type":16,"description":17,"interventionNames":18},"DCB+DP","EXPERIMENTAL","Participants in this group will be received drug-coated balloon angioplasty with debulking procedures.",[19],"Device: paclitaxel-coated balloon angioplasty with debulking procedures",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","paclitaxel-coated balloon angioplasty","No debulking procedures were taken",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"paclitaxel-coated balloon angioplasty with debulking procedures","The patient underwent DCB treatment along with debulking procedures (such as laser or plaque rotational atherectomy, etc.).",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Leng Ni, MD","CONTACT","86-1069152501","nileng@163.com",[38],{"facility":5,"status":26,"city":39,"state":26,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Beijing","100730","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":5,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":52,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100624182","early-phase-1-a-comparative-analysis-of-mid--to-long-term-outcomes-paclitaxel-coated-balloon-with-debulking-versus-paclitaxel-coated-balloon-alone-in-the-treatment-of-chronic-femoropopliteal-artery-occlusions-100624182",false,"NCT07406308","A Comparative Analysis of Mid- to Long-Term Outcomes: Paclitaxel-Coated Balloon With Debulking Versus Paclitaxel-Coated Balloon Alone in the Treatment of Chronic Femoropopliteal Artery Occlusions","A Comparative Analysis of Mid- to Long-Term Outcomes of Paclitaxel-Coated Balloon Angioplasty With Adjunctive Debulking Versus Paclitaxel-Coated Balloon Angioplasty Alone for the Treatment of Chronic Femoropopliteal Artery Occlusions","DCB-Debulk-COM","Inclusion Criteria:\n\n* Subject age 18-85yrs.\n* Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.\n* Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.\n* Rutherford category 2-5.\n* Subject has atherosclerotic de novo, non-stented restenotic, or in-stent restenotic\u002Focclusive lesions in the superficial femoral artery (SFA) and\u002For popliteal artery (P1 segment).\n* Patent inflow artery with stenosis \\\u003C30% by visual estimation (or by core lab assessment if available) and at least 1 infrapopliteal artery to the ankle (\\\u003C50% diameter stenosis).\n* A guidewire has successfully traversed the target treatment segment.\n\nExclusion Criteria:\n\n* Subject presents with acute arterial embolism or thrombosis requiring thrombectomy or thrombolysis for limb ischemia.\n* Subject has arterial occlusion caused by thromboangiitis obliterans (Buerger's disease) or other forms of immune-mediated vasculitis.\n* Subject has undergone surgery on the target vessel within the past 3 months, or has experienced repeated failures of endovascular therapy and is deemed unsuitable for further endovascular intervention.\n* Subject has an uncontrolled thrombophilia or hypercoagulable state.\n* Subject has a severe systemic disease (e.g., malignancy) with a life expectancy of less than 1 year.\n* Subject has contraindications or intolerance to antiplatelet\u002Fanticoagulant medications, such as aspirin, clopidogrel, or heparin.\n* Subject is pregnant or breastfeeding.\n* Subject meets one or more of the following conditions: chronic renal insufficiency (SCr ≥ 2.5 mg\u002FdL) or on regular dialysis; cardiovascular or cerebrovascular surgery within the past 1 month; or severe sequelae from a major stroke.\n* Subject has a known allergy to nitinol alloy, paclitaxel, or contrast agents.","ALL","18 Years","85 Years",{"count":65,"type":66},408,"ESTIMATED","INTERVENTIONAL",[69],"EARLY_PHASE1","This study aims to compare mid-to long-term outcomes of paclitaxel-coated balloon angioplasty with adjunctive debulking versus paclitaxel-coated balloon angioplasty alone for the treatment of chronic femoropopliteal artery diseases.",[72],"Femoropopliteal Artery Occlusion",[72,74,75],"Drug-Coated Balloon","debulking procedures","NOT_YET_RECRUITING","2026-02-05",{"date":79,"type":80},"2026-02-12","ACTUAL",{"date":82,"type":66},"2026-04-20",{"date":84,"type":66},"2028-05-30",{"name":5,"class":6},1]