[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100176099":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":29,"responsibleParty":53,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":85,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Medtronic Endovascular","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug-Coated Balloon (DCB)","EXPERIMENTAL","IN.PACT Admiral: Balloon Angioplasty",[13],"Device: Drug-Coated Balloon (DCB)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard PTA","ACTIVE_COMPARATOR","Standard Percutaneous Balloon Angioplasty (PTA) Balloon: Balloon Angioplasty",[19],"Device: PTA Balloon: Balloon Angioplasty",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm",[9],null,{"type":22,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"PTA Balloon: Balloon Angioplasty",[15],[30,43],{"facility":31,"status":25,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":25},"Washington Hospital","Fremont","California","94538","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-121.98857,37.54827,{"lat":41,"lon":40},{"facility":44,"status":25,"city":45,"state":46,"zip":47,"country":35,"countryCode":36,"cosmosGeoPoint":48,"geoPoint":52,"contacts":25},"Kaiser Permanente Hawaii","Honolulu","Hawaii","96819",{"type":38,"coordinates":49},[50,51],-157.85833,21.30694,{"lat":51,"lon":50},{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100176099","inpact-admiral-drug-coated-balloon-vs-standard-balloon-angioplasty-for-the-treatment-of-superficial-femoral-artery-sfa-and-proximal-popliteal-artery-ppa-100176099",true,"NCT01566461","IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)","Randomized Trial of IN.PACT (Paclitaxel) Admiral Drug-Coated Balloon (DCB) vs. Standard Percutaneous Transluminal Angioplasty (PTA) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and\u002For Proximal Popliteal Artery (PPA)","INPACT SFA II","Inclusion Criteria:\n\n* Age: \\> or equal to 18 years and \\\u003C or equal to 85 years\n* Documented ischemia with Rutherford classification 2, 3, or 4\n* Target lesion in the SFA and\u002For PPA\n* Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria:\n\n  1. 70 - 99% occlusion by visual estimate with lesion length \\> or equal to 4 cm and \\\u003C or equal to 18 cm\n  2. 100% occlusion by visual estimate with lesion length \\\u003C or equal to 10 cm\n  3. Combination lesions must have a total lesion length of \\> or equal to 4 cm and \\\u003C or equal to 18 cm with an occluded segment that is \\\u003C or equal to 10 cm (by visual estimate)\n* Target vessel diameter \\> or equal to 4 mm and \\\u003C or equal to 7 mm\n* Angiographic evidence of adequate distal run-off to the ankle\n* Able to walk without assistive devices\n\nExclusion Criteria:\n\n* Stroke or heart attack within 3 months prior to enrollment\n* Enrolled in another investigational drug, device or biologic study\n* Any surgical procedure or intervention performed within 30 days prior to or post index procedure\n* SFA or PPA disease in the opposite leg that requires treatment at the index procedure\n* Failure to successfully cross the target lesion\n* Angiographic evidence of severe calcification\n* Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices)\n* Known allergies or sensitivity to heparin, aspirin, other anticoagulant\u002Fantiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure\n* Chronic kidney disease",false,"ALL","18 Years","85 Years",{"count":68,"type":69},331,"ACTUAL","INTERVENTIONAL",[72],"NA","The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.",[75,76,77,78],"Femoral Artery Stenosis","Popliteal Artery Stenosis","Femoral Artery Occlusion","Popliteal Artery Occlusion",[80,81,82,83,84],"Drug-Coated Angioplasty Balloon","Drug Coated Angioplasty Balloon","Peripheral Artery Disease","Experimental","Percutaneous Transluminal Angioplasty (PTA)","COMPLETED","2019-01-29",{"date":88,"type":69},"2019-02-12",{"date":90,"type":69},"2012-03",{"date":92,"type":69},"2018-05",{"name":5,"class":6},2]