[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535552":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":45,"centralContacts":50,"locations":59,"responsibleParty":80,"collaborators":84,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":10,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":10,"studyType":111,"phases":10,"briefSummary":112,"conditions":113,"keywords":118,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Clinical Centre of Serbia","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Open surgery",null,"Patients with complex TASC C and D aortoiliac occlusive disease undergoing open surgery: aortobifemoral bypass, crossover bypass, axillobifemoral bypass, aortoiliac endarterectomy, iliofemoral bypass",[13],"Procedure: Open surgery",{"label":15,"type":10,"description":16,"interventionNames":17},"Hybrid repair","Patients with complex TASC C and D aortoiliac occlusive disease undergoing simultaneous open surgical femoral artery reconstruction (endarterectomy, bypass, profundoplasty) and stenting of the iliac axis",[18],"Procedure: Hybrid repair",{"label":20,"type":10,"description":21,"interventionNames":22},"Endovascular repair","Patients with complex TASC C and D aortoiliac occlusive disease undergoing total endovascular repair using different material: bare metal stents (self and balloon expandable), stent-grafts (self and balloon expandable), covered endovascular reconstruction of aortic bifurcation (CERAB), simple plain old balloon angioplasty (POBA)",[23],"Procedure: Endovascular repair",[25,34,39],{"type":26,"name":9,"description":11,"armGroupLabels":27,"otherNames":28},"PROCEDURE",[9],[29,30,31,32,33],"Aortobifemoral bypass","Crossover bypass","Axillobifemoral bypass","Aortoiliac endarterectomy","Iliofemoral bypass",{"type":26,"name":15,"description":16,"armGroupLabels":35,"otherNames":36},[15],[37,38],"Iliac stenting","Femoral endarterectomy",{"type":26,"name":20,"description":21,"armGroupLabels":40,"otherNames":41},[20],[42,43,44],"Bare metal stenting","Covered stent","Plain old balloon angioplasty",[46],{"name":47,"affiliation":48,"role":49},"Joao Rocha Neves, MD PhD","Univeristy of Porto","STUDY_DIRECTOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":10,"email":55},"Petar Zlatanovic, MD FEBVS","CONTACT","+381644961020","petar91goldy@gmail.com",{"name":57,"role":53,"phone":10,"phoneExt":10,"email":58},"Mario D'Oria, MD PhD","mario.doria88@outlook.com",[60],{"facility":61,"status":62,"city":63,"state":10,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Clinical Center of Serbia","RECRUITING","Belgrade","11000","Serbia","RS",{"type":68,"coordinates":69},"Point",[70,71],20.46513,44.80401,{"lat":71,"lon":70},[74,76],{"name":75,"role":53,"phone":54,"phoneExt":10,"email":55},"Petar Zlatanovic, MD",{"name":77,"role":53,"phone":78,"phoneExt":10,"email":79},"Lazar Davidovic, PhD MD","+381113663321","vaskularnahirurgija@gmail.com",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Petar Zlatanovic","Principal investigator",[85,87,89,91,94,96],{"name":86,"class":6},"University of Belgrade",{"name":88,"class":6},"University of Trieste",{"name":90,"class":6},"Centro Hospitalar De São João, E.P.E.",{"name":92,"class":93},"Clinical Center Nis, University of Nis","UNKNOWN",{"name":95,"class":93},"Clinical Center Novi Sad, University of Novi Sad",{"name":97,"class":6},"Institute for Cardiovascular Diseases Dedinje","100535552","treatment-of-tasc-c-and-d-aortoiliac-lesions-100535552",false,"NCT06253312","Treatment of TASC C and D Aortoiliac Lesions","Comparison of Open Surgery, Hybrid and Endovascular Repair for Complex TASC C\u002FD Aortoiliac Lesions","Inclusion Criteria:\n\n* All patients (over 18 years of age) with a history of atherosclerotic peripheral arterial disease treated between 1st January 2015 and 1st January 2022\n* All management strategies will be included (endovascular, hybrid, and open)\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Patients who are under 18 years of age\n* Patients who have acute limb ischemia or acute on chronic ischemia\n* Non-atherosclerotic origin of disease: cyclist disease, trauma, dissection\n* Patients who were treated in conservative manner\n* Patients who underwent primary major amputation\n* Patients with limited life expectancy (less than 2 years)","ALL","18 Years","100 Years",{"count":109,"type":110},900,"ESTIMATED","OBSERVATIONAL","Background:\n\nThe treatment of patients with complex aortoiliac disease (AID), classified as Trans-Atlantic Inter-Society consensus II (TASC) class C and D, presents a dilemma for vascular surgeons. Current guidelines recommend either open surgical reconstruction (OR), hybrid repair (HR) combining iliac stenting with femoral endarterectomy, or total endovascular repair (ER). While traditional OR with aortobifemoral bypass (ABF) is associated with excellent long term patency results, it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8%. The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to OR.\n\nAim:\n\nThe aim of this trial is to evaluate the short, mid-, and long-term results of open repair, hybrid and endovascular repair in the treatment patients with complex, TASC C and D, aortoiliac lesions.\n\nMethodology:\n\nThis is a retrospective cohort study planning to include vascular surgery centers from the following countries: Italy, Portugal, Spain, and Serbia. Data will be collected on demographics, baseline comorbidities, anatomy and morphology of the aortoiliac and femoral bifurcation disease, intraoperative, postoperative, and follow-up data. Propensity score analysis will be performed by matching open repair patients in all three groups (open, hybrid, and endovascular repair) controlling for demographics, baseline comorbidities, anatomical and morphological data.\n\nEndpoints:\n\nPrimary endpoints are all-cause mortality and the major adverse limb events (major amputation - below and above the knee, new onset acute limb ischaemia, reintervention of the treated arterial segment). The secondary endpoints are the 30-day complications and primary patency.",[114,115,116,117],"Peripheral Arterial Disease","Aortoiliac Occlusive Disease","Leriche Syndrome","Peripheral Vascular Disease",[119,120,121,122,123,124,125],"peripheral arterial disease","aortoiliac disease","TASC C,D","open surgery","hybrid repair","endovascular repair","atherosclerosis","2024-08-21",{"date":128,"type":129},"2024-08-23","ACTUAL",{"date":131,"type":129},"2024-05-01",{"date":133,"type":110},"2025-09-01",{"name":5,"class":6},1]