[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618997":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":50,"centralContacts":54,"locations":63,"responsibleParty":82,"collaborators":84,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":10,"enrollmentInfo":98,"targetDuration":10,"studyType":101,"phases":10,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":113,"whyStopped":10,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Cordis US Corp.","INDUSTRY",[8,14,18,23,27,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART 120\u002F150.",null,"The Cordis S.M.A.R.T.TM Nitinol Stent System (SMART 120\u002F150) is indicated in enabling treatment in patients with atherosclerotic disease of the superficial femoral artery (SFA).",[13],"Device: S.M.A.R.T.™ Nitinol Stent System (SMART 120\u002F150)",{"label":15,"type":10,"description":16,"interventionNames":17},"Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART 120\u002F150.","The Cordis S.M.A.R.T.TM Nitinol Stent System (SMART 120\u002F150) is indicated in enabling treatment in patients with atherosclerotic disease of the proximal popliteal artery (PPA).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Subjects with stenotic lesions of the iliac artery treated with SMART CONTROL.","The Cordis S.M.A.R.T.TM CONTROLTM Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of the iliac artery.",[22],"Device: S.M.A.R.T.™ CONTROL ™ Nitinol Stent System",{"label":24,"type":10,"description":25,"interventionNames":26},"Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART CONTROL.","The Cordis S.M.A.R.T.TM CONTROLTM Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of the superficial femoral artery (SFA).",[22],{"label":28,"type":10,"description":29,"interventionNames":30},"Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART Flex.","The Cordis S.M.A.R.T.TM Flex Stent is indicated in enabling treatment of patients with symptomatic vascular stenotic and\u002For occlusive diseases in the superficial femoral artery (SFA).",[31],"Device: S.M.A.R.T.™ Flex Vascular Stent System",{"label":33,"type":10,"description":34,"interventionNames":35},"Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART Flex.","The Cordis S.M.A.R.T.TM Flex Stent is indicated in enabling treatment of patients with symptomatic vascular stenotic and\u002For occlusive diseases in the proximal popliteal artery (PPA).",[31],[37,42,46],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"DEVICE","S.M.A.R.T.™ Nitinol Stent System (SMART 120\u002F150)","The Cordis S.M.A.R.T.™ Nitinol Stent System is intended to deliver a self-expanding endovascular stent to the peripheral vasculature via a sheathed delivery system. The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T. ™ Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of the superficial femoral artery and proximal popliteal artery.",[15,9],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"S.M.A.R.T.™ CONTROL ™ Nitinol Stent System","The Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System is intended to deliver a self-expanding endovascular stent to the iliac and\u002For superficial femoral arteries via a sheathed delivery system. The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T. ™ CONTROL™ Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of iliac and\u002For superficial femoral arteries.",[19,24],{"type":38,"name":47,"description":48,"armGroupLabels":49,"otherNames":10},"S.M.A.R.T.™ Flex Vascular Stent System","The Cordis S.M.A.R.T.™ Flex Stent is a single-use device consisting of an endovascular stent and sheath delivery system, intended to deliver a self-expanding endovascular stent to the superficial femoral artery (SFA). The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T.™ Flex Stent is indicated in enabling treatment of patients with symptomatic vascular stenotic and\u002For occlusive diseases in the superficial femoral artery and proximal popliteal artery.",[33,28],[51],{"name":52,"affiliation":5,"role":53},"Nusrath Sultana","STUDY_DIRECTOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":10,"email":59},"Kwame Ofori","CONTACT","832-407-3326","kwame.ofori@cordis.com",{"name":61,"role":57,"phone":10,"phoneExt":10,"email":62},"Rajesh Nathan","rajesh.nathan@cordis.com",[64],{"facility":65,"status":10,"city":66,"state":10,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Hospital Clinico San Carlos","Madrid","28040","Spain","ES",{"type":71,"coordinates":72},"Point",[73,74],-3.70256,40.4165,{"lat":74,"lon":73},[77,79],{"name":78,"role":57,"phone":10,"phoneExt":10,"email":10},"Martin Lagos, Prof",{"name":80,"role":81,"phone":10,"phoneExt":10,"email":10},"Isaac M Lopez, MD","PRINCIPAL_INVESTIGATOR",{"type":83,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[85],{"name":86,"class":87},"Rede Optimus Hospitalar SA","NETWORK","100618997","post-market-clinical-follow-up-of-smart-family-of-stents-in-treating-iliac-and-femoropopliteal-artery-disease-100618997",false,"NCT07338890","Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease","Post-Market Clinical Follow-Up Study of the S.M.A.R.T.™ Nitinol Stent System, S.M.A.R.T.™ CONTROL™ Nitinol Stent System and S.M.A.R.T. ™ Flex Vascular Stent System in the Treatment of Iliac and Femoropopliteal Artery Disease (REAL-SMART)","REAL-SMART","Inclusion Criteria: For data mining purposes, the following criteria will apply in determining which subjects to include in the study:\n\n* Subjects treated with SMART 120\u002F150, SMART CONTROL or SMART Flex according to the respective Instructions for Use for treatment in the iliac, superficial femoral and\u002For proximal popliteal arteries.\n* If an EC-approved informed consent waiver is not obtained, then documented informed consent from the subject or legal representative granting permission to share the subject's clinical data It is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment\u002Fprocedure or until time of death, whichever came first.\n\nIt is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment\u002Fprocedure or until time of death, whichever came first. Subjects not included because follow-up information is unavailable will be documented, wherever possible, with respect to demographics and presenting disease state to determine whether they are similar to subjects with follow-up that are enrolled.\n\nExclusion Criteria: For data mining purposes, the following criteria will apply in determining which subjects to exclude in the study:\n\n* Women who were pregnant or lactating at the time of the procedure.\n* Pediatric subjects (\\\u003C18 years of age) at the time of the procedure.","ALL","18 Years",{"count":99,"type":100},240,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to evaluate long-term safety and performance per the intended use of the S.M.A.R.T.™ Nitinol Stent System (SMART 120\u002F150), S.M.A.R.T.™ CONTROL™ Nitinol Stent System (SMART CONTROL) and S.M.A.R.T.™ Flex Vascular Stent System (SMART Flex) in the treatment of iliac and femoropopliteal artery disease.",[104,105,106],"Superficial Femoral Artery Stenosis","Iliac Artery Stenosis","Popliteal Artery Stenosis",[104,105,106,108,109,110,111,112],"SMART CONTROL Nitinol Stent System","SMART FLEX Vascular Stent System","SMART Nitinol Stent System","SFA Stenosis","PPA Stenosis","NOT_YET_RECRUITING","2026-01-04",{"date":116,"type":117},"2026-01-14","ACTUAL",{"date":119,"type":100},"2026-01-31",{"date":121,"type":100},"2026-05-30",{"name":5,"class":6},1]