[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100205169":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":25,"locations":33,"responsibleParty":46,"collaborators":25,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":77,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Medtronic Endovascular","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MDT-2113 Drug-Eluting Balloon","EXPERIMENTAL","Paclitaxel drug-eluting angioplasty balloon",[13],"Device: MDT-2113 Drug-Eluting Balloon",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard angioplasty balloon","ACTIVE_COMPARATOR","Standard PTA balloon without Paclitaxel drug-elution",[19],"Device: Standard angioplasty balloon",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":31,"role":32},"Osamu Iida, MD","Kansai Rosai Hospital, Amagasaki, Hyogo, Japan","PRINCIPAL_INVESTIGATOR",[34],{"facility":35,"status":25,"city":36,"state":37,"zip":25,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":25},"Kansai Rosai Hospital","Amagasaki","Hyōgo","Japan","JP",{"type":41,"coordinates":42},"Point",[43,44],135.41667,34.71667,{"lat":44,"lon":43},{"type":47,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100205169","mdt-2113-drug-eluting-balloon-vs-standard-pta-for-the-treatment-of-atherosclerotic-lesions-in-the-superficial-femoral-artery-andor-proximal-popliteal-artery-100205169",false,"NCT01947478","MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and\u002For Proximal Popliteal Artery","Randomized Trial of MDT-2113 Drug-Eluting Balloon (DEB) vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and\u002For Proximal Popliteal Artery","MDT-2113 SFA","Inclusion Criteria:\n\n* Age: ≥ 20 years and ≤ 85 years\n* Documented ischemia with Rutherford classification 2, 3, or 4\n* Able to walk without assistive devices\n* Target lesion is in the SFA and\u002For PPA above the knee\n* Target lesion consists of a single de novo or non-stented restenotic lesion (or tandem lesions) or is a combination lesion that meets the following criteria:\n\n  1. ≥ 70% and \\\u003C 100% occluded with total lesion length ≥ 40 mm and ≤ 200 mm\n  2. 100% occluded with total lesion length ≤100 mm\n  3. Combination lesions must have total lesion length ≥40 mm and ≤200 mm with an occluded segment that is ≤ 100 mm in length (by visual estimates)\n* Reference vessel diameter ≥ 4 mm and ≤7 mm (by visual estimate)\n* Angiographic evidence of adequate distal run-off through the foot\n\nExclusion Criteria:\n\n* Stroke or STEMI within the 3 months prior to enrollment\n* Either local or systemic thrombolytic therapy within the 48 hours prior to the index procedure\n* Inability to tolerate oral anticoagulation therapy (blood thinners such as warfarin) while on concomitant dual antiplatelet therapy (DAPT)\n* Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant\u002Fantiplatelet therapies or to paclitaxel, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure\n* Chronic renal insufficiency\n* Subject is enrolled in another investigational device, drug, or biologic study\n* Any major surgical procedure or intervention performed within the 30-day period prior to or post index procedure\n* Contralateral SFA\u002FPPA disease requiring treatment in the same setting as index procedure\n* Failure to successfully cross the target lesion\n* Angiographic evidence of severe calcification\n* Target lesion known in advance of enrollment to require treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices, cutting balloons, scoring balloons; use of embolic protection devices is also prohibited","ALL","20 Years","85 Years",{"count":60,"type":61},100,"ACTUAL","INTERVENTIONAL",[64],"NA","The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery (PPA) as compared to treatment with standard percutaneous transluminal angioplasty (PTA).",[67,68,69,70],"Femoral Artery Stenosis","Popliteal Artery Stenosis","Femoral Artery Occlusion","Popliteal Artery Occlusion",[72,73,74,75,76],"Drug-Eluting Angioplasty Balloon","Drug Coated Angioplasty Balloon","Peripheral Artery Disease","Experimental","Percutaneous Transluminal Angioplasty (PTA)","COMPLETED","2019-01-29",{"date":80,"type":61},"2019-01-31",{"date":82,"type":61},"2013-09",{"date":84,"type":61},"2018-04",{"name":5,"class":6},1]