[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607328":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":20,"responsibleParty":53,"collaborators":11,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":11,"overallStatus":73,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"BrosMed Medical Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"VaSecure Drug-Coated Peripheral Balloon Dilatation Catheter","EXPERIMENTAL",null,[13],"Device: drug coating balloon angioplasty",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","drug coating balloon angioplasty","The subjects underwent drug coating balloon angioplasty to treat femoropopliteal artery stenosis or occlusive lesions",[9],[21,39],{"facility":22,"status":11,"city":23,"state":24,"zip":11,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Xuanwu Hospital Capital Medical University","Beijing","Beijing Municipality","China","CN",{"type":28,"coordinates":29},"Point",[30,31],116.39723,39.9075,{"lat":31,"lon":30},[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"Lianrui Guo","CONTACT","010-83199270","Guolianrui@xwhosp.org",{"facility":40,"status":11,"city":41,"state":42,"zip":11,"country":25,"countryCode":26,"cosmosGeoPoint":43,"geoPoint":47,"contacts":48},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","Chognqing",{"type":28,"coordinates":44},[45,46],106.55771,29.56026,{"lat":46,"lon":45},[49],{"name":50,"role":36,"phone":51,"phoneExt":11,"email":52},"Fenghe Li","023-89011876","Lifenghe@163.com",{"type":54,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100607328","a-post-market-study-of-drug-coated-peripheral-balloon-dilatation-catheter-in-treating-femoropopliteal-artery-stenosis-or-occlusive-lesions-100607328",false,"NCT07187128","A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.","Inclusion Criteria:\n\n1. Aged 18 to 85 years, gender not restricted;\n2. Rutherford grade 2 to 5\n3. Target lesions located in the superficial femoral artery (SFA) and\u002For proximal popliteal artery requiring percutaneous transluminal angioplasty (PTA), with the following characteristics:\n\n   * Diameter stenosis ≥70% by visual estimation or\n   * Chronic total occlusion (CTO)\n4. At least one native below-the-knee artery supplying the foot on the affected side preoperatively;\n5. The guidewire can successfully pass through the target lesion site within the vascular lumen;\n6. Agree to participate in this clinical study and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Absence of proximal inflow tract or persistent lack of proximal inflow after pretreatment\n2. Type D or higher dissection occurring after target lesion predilation;\n3. Residual diameter stenosis \\>50% following target lesion predilation;\n4. Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.;\n5. Abnormal function of vital organs (liver\u002Fkidney\u002Fbrain) deemed unsuitable for intervention by investigators;\n6. Documented allergy to aspirin, clopidogrel, heparin, paclitaxel\u002Fstructural analogs, or contrast agents;\n7. Patients currently undergoing dialysis or immunosuppressive therapy;\n8. Presence of detectable thrombus in lower extremity arteries requiring intraoperative thrombolysis;\n9. History of stroke or ST-elevation myocardial infarction within 6 months prior to procedure;\n10. Pregnancy or lactation women;\n11. Currently participation in other drug\u002Fmedical device clinical trials without completion;\n12. Patients deemed by the investigator to be unsuitable for participation in this study.","ALL","18 Years","85 Years",{"count":65,"type":66},150,"ESTIMATED","INTERVENTIONAL",[69],"NA","T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions.",[72],"Femoropopliteal Artery Stenoses or Occlusive Lesions","NOT_YET_RECRUITING","2025-09-15",{"date":76,"type":77},"2025-09-22","ACTUAL",{"date":76,"type":66},{"date":80,"type":66},"2028-12-30",{"name":5,"class":6},2]