[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522426":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":38,"locations":46,"responsibleParty":64,"collaborators":11,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":11,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Paracelsus Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Autologous Bypass","ACTIVE_COMPARATOR",null,[13],"Procedure: Conventional Autologous Bypass",{"label":15,"type":10,"description":11,"interventionNames":16},"FRAMED Infrainguinal Venous Bypass",[17],"Procedure: FRAMED Infrainguinal Venous Bypass",[19,23],{"type":20,"name":15,"description":21,"armGroupLabels":22,"otherNames":11},"PROCEDURE","The harvested vein graft will be covered with a mesh.",[15],{"type":20,"name":9,"description":24,"armGroupLabels":25,"otherNames":11},"The harvested vein graft will be used without a mesh coating.",[9],[27,31,35],{"name":28,"affiliation":29,"role":30},"Stephan Koter, MD, PD","Senior Physician","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":34},"Stephanie Rassam, MD","Resident Physician","STUDY_DIRECTOR",{"name":36,"affiliation":37,"role":30},"Klaus Linni, MD, PD, FEBVS","Head of Division",[39,43],{"name":32,"role":40,"phone":41,"phoneExt":11,"email":42},"CONTACT","+43 572550 57506","s.rassam@salk.at",{"name":28,"role":40,"phone":44,"phoneExt":11,"email":45},"+43 572550 55677","s.koter@salk.at",[47],{"facility":48,"status":49,"city":50,"state":11,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University Hospital of Salzburg, Paracelsus Medical University","RECRUITING","Salzburg","5020","Austria","AT",{"type":55,"coordinates":56},"Point",[57,58],13.04399,47.79941,{"lat":58,"lon":57},[61],{"name":62,"role":40,"phone":11,"phoneExt":11,"email":63},"Klaus Linni, MD PD","k.linni@salk.at",{"type":30,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Klaus Linni","Head of Division of Vascular and Endovascular Surgery, MD PD","100522426","framed-infrainguinal-venous-bypass-versus-conventional-autologous-bypass-trial-100522426",false,"NCT06082466","FRAMED Infrainguinal Venous Bypass Versus Conventional Autologous Bypass Trial","Framed IVB","Inclusion Criteria\n\n* Age at least 18 years\n* Informed consent form with signature\n* Rutherford Category 3 (\\\u003C200m) or chronic critical ischemia (Rutherford Category 4-6)\n* Assured inflow and recipient artery.\n\nExclusion Criteria\n\n* Pregnant or breastfeeding women\n* Active infection or sepsis\n* Acute ischemia\n* Endovascular procedure in the region to be treated.\n* Vein with outer diameter \\\u003C3.5 mm or \\>8 mm under pressure.\n* Spliced Veins.\n* Known allergy to the cobalt-chromium alloy (ASTM 1058) or its components (Cobalt-Chromium-Iron-Nickel-Molybdenum).\n* Vasculitis\n* Coagulopathy\n* Radiation therapy near the anastomosis","ALL","18 Years",{"count":77,"type":78},110,"ESTIMATED","INTERVENTIONAL",[81],"NA","The purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.",[84,85,86,87,88],"Peripheral Arterial Occlusive Disease","Femoropopliteal Artery Occlusion","Femoropopliteal Stenosis","Critical Limb-Threatening Ischemia","Claudication, Intermittent",[90,91,92],"Extraluminal Bypass Stenting","Autologous Vein Graft","Bypass Extremity Graft","2023-11-20",{"date":95,"type":96},"2023-11-21","ACTUAL",{"date":98,"type":96},"2023-09-11",{"date":100,"type":78},"2027-09",{"name":5,"class":6},1]