[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100206865":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":29,"responsibleParty":64,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":25,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":86,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":25,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Ospedale San Donato","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PEB","ACTIVE_COMPARATOR","PEB angioplasty plus provisional nitinol stent implantation",[13],"Device: PEB",{"label":15,"type":16,"description":17,"interventionNames":18},"PES","EXPERIMENTAL","Systematic PES angioplasty",[19],"Device: PES",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Systematic Paclitaxel eluting stent angioplasty",[15],[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Cardiovascular Department, Ospedale S.Donato","RECRUITING","Arezzo","AR","52100","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],11.88068,43.46276,{"lat":42,"lon":41},[45,49,52,55,57,59,60,62],{"name":46,"role":47,"phone":25,"phoneExt":25,"email":48},"Francesco Liistro, MD","CONTACT","francescoliistro@hotmail.com",{"name":50,"role":51,"phone":25,"phoneExt":25,"email":25},"Leonardo Bolognese, MD, FESC","PRINCIPAL_INVESTIGATOR",{"name":53,"role":54,"phone":25,"phoneExt":25,"email":25},"Giovanni Falsini, MD","SUB_INVESTIGATOR",{"name":56,"role":54,"phone":25,"phoneExt":25,"email":25},"Paolo Angioli, MD",{"name":58,"role":54,"phone":25,"phoneExt":25,"email":25},"Kenneth Ducci, MD",{"name":46,"role":51,"phone":25,"phoneExt":25,"email":25},{"name":61,"role":54,"phone":25,"phoneExt":25,"email":25},"Simone Grotti, MD",{"name":63,"role":54,"phone":25,"phoneExt":25,"email":25},"Italo Porto, MD",{"type":51,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Leonardo Bolognese, MD","Director","100206865","phase-4-paclitaxel-eluting-balloon-angioplasty-with-provisional-use-of-nitinol-stent-versus-systematic-implantation-of-paclitaxel-eluting-stent-for-the-treatment-of-femoropopliteal-de-novo-lesions-100206865",false,"NCT01969630","Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions","Inclusion Criteria:\n\n* intermittent claudication or critical limb ischemia\n* de novo stenosis ≥ 50% or occlusion of at least 40 mm in length located in femoropopliteal arteries\n* presence of a clear healthy segment between the lesion in superficial femoral and common femoral artery and between popliteal and tibioperoneal trunk\n* presence of at least 1 patent tibial vessel with distal run-off (below-the-knee artery was considered patent if free from obstructive lesions determining angiographic stenosis \\>70%)\n\nExclusion Criteria:\n\n* life expectancy \\\u003C1 year\n* contraindication for combined antiplatelet therapy or known allergy to nickel or paclitaxel\n* need for major amputation (MA) at the time of enrolment\n* Failure to recanalize intended below-the-knee arteries in CLI patients at risk of major amputation","ALL","18 Years",{"count":76,"type":77},250,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty",[83],"Peripheral Artery Disease",[85],"femoropopliteal lesions","UNKNOWN","2013-10-21",{"date":89,"type":77},"2013-10-25",{"date":91,"type":25},"2013-10",{"name":5,"class":6},1]