[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560153":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":56,"studyPopulation":57,"armGroups":52,"interventions":58,"overallOfficials":63,"centralContacts":68,"locations":74,"responsibleParty":153,"collaborators":52,"id":155,"slug":52,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":156,"sex":162,"minAge":163,"maxAge":52,"enrollmentInfo":164,"targetDuration":52,"studyType":167,"phases":52,"briefSummary":168,"conditions":169,"keywords":52,"overallStatus":77,"whyStopped":52,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Braile Biomedica Ind. Com. e Repr. Ltda.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":52},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Incidence of Device-Related Serious Adverse Events (Device Safety)","Absence of major serious adverse events occurring within 30 days after the index procedure, defined as device- or procedure-related death, acute myocardial infarction (AMI), or above-the-metatarsal amputation in the treated leg due to a vascular event","30 days post-index procedure",{"measure":14,"description":15,"timeFrame":16},"Number of Patients with Technical Success (Device Performance)","Technical success with the absence of serious adverse events related to the device","Intraoperative",{"measure":18,"description":19,"timeFrame":20},"Number of Patients Without Rupture or Dissection of the Treated Vessel (Combined Safety and Performance Outcome)","Absence of rupture or dissection of the treated vessel within 30 days after the procedure","30 days post index procedure",[22,25,28,32,35,38,41,45,49],{"measure":23,"description":24,"timeFrame":16},"Rate of Technical Success","Defined as the successful deployment of the endoprosthesis at the intended site with patency and absence of significant device deformities (e.g., kinks, stent eversion, twisting)",{"measure":26,"description":27,"timeFrame":20},"Rate of Procedural Success","Defined as the absence of serious adverse events related to the device within 30 days",{"measure":29,"description":30,"timeFrame":31},"Incidence of Adverse Events","Defined as device- or procedure-related death, bleeding or hematoma, myocardial infarction (MI), thrombosis, arterial rupture or dissection, or amputation above the metatarsal in the treated leg due to a vascular event","30 days, 3, 6, 9, and 12 months",{"measure":33,"description":34,"timeFrame":16},"Conversion Rate to Open Surgery","Rate of patients who required conversion to open surgery",{"measure":36,"description":37,"timeFrame":20},"Primary Patency Rate","Defined as the absence of restenosis \\> 50% within 30 days",{"measure":39,"description":40,"timeFrame":31},"Number of Patients with Clinical Success","Defined by symptom improvement",{"measure":42,"description":43,"timeFrame":44},"Rate of Target Vessel Patency","Absence of restenosis \\> 50%","3, 6, 9, and 12 months",{"measure":46,"description":47,"timeFrame":48},"Limb Salvage Rate","When patients with rest pain experienced pain relief and those with foot ulcers showed improved perfusion, avoiding the need for amputation","30 days, 6, 9, and 12 months",{"measure":50,"description":51,"timeFrame":31},"Need for Endovascular Reintervention at the Target Lesion","Percentage of patients who required additional endovascular procedures at the same anatomical site as the initial intervention",null,{"allocation":52,"interventionModel":52,"interventionModelDescription":52,"primaryPurpose":52,"observationalModel":54,"timePerspective":55,"maskingInfo":52},"COHORT","PROSPECTIVE","Multicenter study aimed at collecting post-market clinical data on the VESTO® vascular stent for the treatment of patients with iliac peripheral arterial occlusive disease requiring endovascular intervention. The objective of the study is to evaluate the short-term (12-month) safety and clinical performance of the Vesto® vascular stent in patients with iliac peripheral arterial occlusive disease.","Patients with iliac peripheral artery obstructive disease requiring endovascular treatment.",[59],{"type":60,"name":61,"description":62,"armGroupLabels":52,"otherNames":52},"DEVICE","Vascular Stent - Vesto Endoprosthesis","Vascular Stent Implant - Vesto Endoprosthesis",[64],{"name":65,"affiliation":66,"role":67},"Fabio Cypreste Oliveira","Hospital Santa Helena","PRINCIPAL_INVESTIGATOR",[69],{"name":70,"role":71,"phone":72,"phoneExt":52,"email":73},"Glaucia Basso","CONTACT","+55 (17) 2136-7005","glaucia.basso@braile.com.br",[75,92,103,115,128,141],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Hospital Ana Nery","RECRUITING","Salvador","Estado de Bahia","40301-155","Brazil","BR",{"type":84,"coordinates":85},"Point",[86,87],-38.49096,-12.97563,{"lat":87,"lon":86},[90],{"name":91,"role":67,"phone":52,"phoneExt":52,"email":52},"André Brito",{"facility":66,"status":77,"city":93,"state":94,"zip":95,"country":81,"countryCode":82,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Goiânia","Goiás","74083-100",{"type":84,"coordinates":97},[98,99],-49.25389,-16.67861,{"lat":99,"lon":98},[102],{"name":65,"role":67,"phone":52,"phoneExt":52,"email":52},{"facility":104,"status":77,"city":105,"state":105,"zip":106,"country":81,"countryCode":82,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Hospital Universitário Pedro Ernesto (HUPE-UERJ)","Rio de Janeiro","20551-030",{"type":84,"coordinates":108},[109,110],-43.18223,-22.90642,{"lat":110,"lon":109},[113],{"name":114,"role":67,"phone":52,"phoneExt":52,"email":52},"Cristina Rigetti",{"facility":116,"status":77,"city":117,"state":118,"zip":119,"country":81,"countryCode":82,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"HCFMB-UNESP - Hospital das Clínicas da Faculdade de Medicina de Botucatu da Universidade Estadual Paulista","Botucatu","São Paulo","18618-970",{"type":84,"coordinates":121},[122,123],-48.445,-22.88583,{"lat":123,"lon":122},[126],{"name":127,"role":67,"phone":52,"phoneExt":52,"email":52},"Marcone Sobreira",{"facility":129,"status":130,"city":131,"state":118,"zip":132,"country":81,"countryCode":82,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Hospital de Clínicas da Universidade Estadual de Campinas","NOT_YET_RECRUITING","Campinas","13083-888",{"type":84,"coordinates":134},[135,136],-47.06083,-22.90556,{"lat":136,"lon":135},[139],{"name":140,"role":67,"phone":52,"phoneExt":52,"email":52},"Ana Terezinha Guillaumon",{"facility":142,"status":77,"city":143,"state":118,"zip":144,"country":81,"countryCode":82,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto","Ribeirão Preto","14015-010",{"type":84,"coordinates":146},[147,148],-47.81028,-21.1775,{"lat":148,"lon":147},[151],{"name":152,"role":67,"phone":52,"phoneExt":52,"email":52},"Edwaldo Joviliano",{"type":154,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100560153",false,"NCT06573437","Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease","Clinical Performance of the VESTO® Vascular Stent for Treatment of Iliac Peripheral Obstructive Arterial Disease - Post Market Clinical Trial Iliac Stent Trial","VESTO-ILIAC","Inclusion Criteria:\n\n1. 18 years of age or older;\n2. TASC-II aortoiliac lesion classification of modified class A, B, C, or D;\n3. Rutherford classification score of 2 to 5;\n4. Access site compatibility with the device delivery system;\n5. Compliance with the device's instructions for use (IFU);\n6. Patient availability for appropriate follow-up times for the duration of the study;\n7. Patient informed about the nature of the study, agreeing to its provisions, and signing the informed consent form.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to heparin, contrast media, or stent components;\n2. Patient with blood dyscrasia;\n3. Pregnant or breastfeeding women;\n4. Patient currently participating in an investigational drug or device study;\n5. Patient undergoing chemotherapy or radiation therapy;\n6. Patient with a stent or graft located in the target limb;\n7. Patient who underwent angioplasty or bypass surgery within 30 days prior to inclusion in this study;\n8. Patient with a life expectancy of less than 12 months;\n9. Inability to undergo dual antiplatelet therapy (DAPT)","ALL","18 Years",{"count":165,"type":166},100,"ESTIMATED","OBSERVATIONAL","This study will validate the efficacy and safety of the VESTO® Vascular Stent for treating patients with iliac peripheral arterial obstructive disease in a post-market clinical trial",[170],"Peripheral Arterial Disease","2025-03-21",{"date":173,"type":174},"2025-03-26","ACTUAL",{"date":176,"type":174},"2024-06-21",{"date":178,"type":166},"2026-08",{"name":5,"class":6},6]