[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"femoropopliteal-artery-stenoses-or-occlusive-lesions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:femoropopliteal-artery-stenoses-or-occlusive-lesions":26},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"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":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Femoropopliteal Artery Stenoses or Occlusive Lesions","NOT_YET_RECRUITING","2025-09-15",{"date":30,"type":31},"2025-09-22","ACTUAL",{"date":30,"type":20},{"date":34,"type":20},"2028-12-30",{"name":36,"class":37},"BrosMed Medical Co., Ltd","INDUSTRY",2]