[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479000":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":47,"collaborators":25,"id":49,"slug":25,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":25,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":25,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":25,"overallStatus":34,"whyStopped":25,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DCB","EXPERIMENTAL","participants in this group will be received drug-coated balloon angioplasty",[13],"Device: paclitaxel-coated balloon angioplasty or bare mental stents implantation",{"label":15,"type":16,"description":17,"interventionNames":18},"stenting","ACTIVE_COMPARATOR","participants in this group will be received primary selective stenting",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","paclitaxel-coated balloon angioplasty or bare mental stents implantation","paticipants who enrolled in this study will received paclitaxel-coated balloon angioplasty plus bailout stenting or primary bare mental stents implantation randomly",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Leng Ni, MD","CONTACT","86-1069152501","nileng@163.com",[33],{"facility":5,"status":34,"city":35,"state":25,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Beijing","100730","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},{"type":48,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100479000",false,"NCT05517291","DCB Versus Primary Selective Stenting in TASC C\u002FD Femoropopliteal Artery Disease","Paclitaxel Coated Balloon Angioplasty Versus Primary Selective Stenting in the Treatment of TASC C\u002FD Chronic Femoropopliteal Artery Occlusive Disease: A Multicenter Randomized Clinical Trial","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 a de novo TASC C\u002FD femoropopliteal artery lesions which does not exceed to the segment P1 of popliteal artery.\n* The total length of target lesion ≤30cm.\n* Reference vessel diameter \\>4 mm and \\\u003C6.5 mm by visual assessment.\n* Patent inflow artery with stenosis \\\u003C30% 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* Acute thrombus in the target vessels.\n* Vessel stenosis or occlusion due to Buerger's disease or autoimmune arteritis.\n* Subject received prior stents implantation with in-stent restenosis or occlusion.\n* Reintervention of the target lesion \\\u003C90 days before the study procedure.\n* Acquired thrombophilia or uncontrolled hypercoagulation states.\n* Life expectancy \\\u003C12 months.\n* Severe renal（SCr≥2.5 mg\u002Fdl）or hemodialysis dependence.\n* Pregnancy, suspected pregnancy, or breastfeeding during study period.\n* Contraindication to contrast media or any study-required medication (antiplatelet, anticoagulant, or thrombolytic agents, etc.).\n* Hypersensitivity to nitinol and\u002For paclitaxel.","ALL","18 Years","85 Years",{"count":59,"type":60},200,"ESTIMATED","INTERVENTIONAL",[63],"NA","This study aims to compare the mid- and long-term outcomes between paclitaxel-coated balloon and primary selective stenting in the treatment of TASC C\u002FD femoropopliteal artery occlusive disease.",[66,67],"Safety Issues","Efficacy, Self","2022-12-04",{"date":70,"type":71},"2022-12-06","ACTUAL",{"date":73,"type":71},"2022-09-18",{"date":75,"type":60},"2027-12-31",{"name":5,"class":6},1]