[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634355":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":27,"locations":18,"responsibleParty":37,"collaborators":18,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":18,"eligibilityCriteria":44,"healthyVolunteers":41,"sex":45,"minAge":46,"maxAge":18,"enrollmentInfo":47,"targetDuration":18,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":63,"overallStatus":77,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":18},{"fullName":5,"class":6},"W.L.Gore & Associates","INDUSTRY",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"GORE® VIABAHN® FORTEGRA Venous Stent","EXPERIMENTAL",[12],"Device: GORE® VIABAHN® FORTEGRA Venous Stent",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"DEVICE","Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.",[9],null,[20,24],{"name":21,"affiliation":22,"role":23},"Erin Murphy, MD","Atrium Health Sanger Heart and Vascular Institute","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":26,"role":23},"Parag Patel, MD","Medical College of Wisconsin",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Carl Conway","CONTACT","617 595 2277","cconway@wlgore.com",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},"Chaz Wolf","928 814 9198","cwolf@wlgore.com",{"type":38,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100634355","the-gore-viabahn-fortegra-venous-stent-post-approval-study-100634355",false,"NCT07538609","The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study","Preoperative Inclusion Criteria:\n\n* Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an investigator\u002Fsub-investigator.\n* Patient is at least 18 years of age.\n* Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.\n* Patient is able to provide informed consent themself.\n\nIntraoperative Inclusion Criteria:\n\n* Patient can accommodate an appropriately sized GORE® VIABAHN® FORTEGRA Venous Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.\n* Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.\n* Patient has adequate landing zones free from significant disease requiring treatment beyond the proximal and distal margins of the lesion.\n* Patient has adequate inflow\u002Foutflow to\u002Ffrom the target lesion(s), per investigator\u002Fsub- investigator discretion.\n* Lesion can be traversed with a guidewire.\n\nIntraoperative Exclusion Criteria:\n\n* Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.","ALL","18 Years",{"count":48,"type":49},150,"ESTIMATED","INTERVENTIONAL",[52],"NA","This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.",[55,56,57,58,59,60,61,62],"Venous Thromboses","Venous Disease","Venous Leg Ulcer","Venous Stasis","Venous Ulcer","Venous Stenosis","Venous Occlusion","Vein Thrombosis",[64,65,66,60,67,68,69,70,71,72,56,73,74,75,76],"Vein Stent","VIAFORT","Venous Thrombosis","Gore","Venous occlusion","VIABAHN FORTEGRA","FORTEGRA","Deep Venous Insufficiency","Deep venous","DVT Treatment","Venous Stent","Venous insufficiency treatment options","Venous disease treatment options","NOT_YET_RECRUITING","2026-05-11",{"date":80,"type":81},"2026-05-14","ACTUAL",{"date":83,"type":49},"2026-10-07",{"date":85,"type":49},"2031-05",{"name":5,"class":6}]