[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614442":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":60,"collaborators":10,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":73,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"W.L.Gore & Associates","INDUSTRY",[8,14,17,20,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Aortoiliac Occlusive Disease: De novo or rest. lesions in the iliac arteries include aortic bifurcat",null,"Device: Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) Intent to treat with Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) in the treatment of Peripheral Artery Disease as part of routine clinical practice.",[13],"Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)",{"label":15,"type":10,"description":11,"interventionNames":16},"Visceral Artery Occlusive Disease (VAOD): De novo or restenotic lesions in the visceral arteries",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Isolated Artery Aneurysmal Disease (IAA): Isolated visceral, iliac, and subclavian artery aneurysms",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Trauma or Iatrogenic Vessel Injury: are located in the chest cavity, abdominal cavity, or pelvis",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"Other (subjects not fitting into the categories above)",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"DEVICE","Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)","This registry will collect data for eligible commercially available BXB device(s). The BXB device(s) will not be provided to the sites by the Sponsor. The BXB device implant procedure will be performed according to standard practice of the enrolling institution.",[9,18,24,21,15],[33],{"name":34,"affiliation":35,"role":36},"Daniele Branzan, Prof. Dr.","TUM Klinikum","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Cagla Selvan","CONTACT","+31 627 294 665","cselvan@wlgore.com",{"name":44,"role":40,"phone":45,"phoneExt":10,"email":46},"Valerie Jeans","+33(0)6 74 74 26 98","vjean@wlgore.com",[48],{"facility":35,"status":49,"city":50,"state":10,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":10},"RECRUITING","Munich","81675","Germany","DE",{"type":55,"coordinates":56},"Point",[57,58],11.57549,48.13743,{"lat":58,"lon":57},{"type":61,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100614442","gore-viabahn-vbx-balloon-expandable-endoprosthesis-post-market-clinical-follow-up-pmcf-observational-registry-re-prove-100614442",false,"NCT07279649","GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Informed Consent Form (ICF) is signed by subject\n3. Suitable for endovascular treatment with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) device\n4. Willingness of the subject to adhere to institutional standard of care follow-up requirements\n\nExclusion Criteria:\n\n1. Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or subject requires enrollment into more than one cohort) (Note: Only the first treatment will be enrolled if concurrent procedures are performed that would require enrollment into more than one cohort).\n2. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.\n3. Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.\n4. Life expectancy \\\u003C12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites.\n5. Known intolerance to anticoagulant and \u002F or antiplatelet therapy at the time of the index procedure\n6. Subject has a known allergy to contrast or the Reduced Profile VBX Stent (BXB) device components at the time of index procedure that cannot be adequately mitigated.\n7. Pregnant or breast-feeding subject at time of informed consent signature.\n8. Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).","ALL","18 Years",{"count":71,"type":72},240,"ESTIMATED","12 Months","OBSERVATIONAL","Collect real-world post-market clinical follow-up data on subjects treated with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)",[77,78,79,80],"Aorto-iliac Occlusive Disease (AIOD)","Visceral Artery Occlusive Disease (VAOD)","Isolated Artery Aneurysms (IAA)","Trauma or Iatrogenic Vessel Injury",[82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98],"Peripheral Vascular Disease","Peripheral Arterial Disease","Aneurysm","Cardiovascular Disease","Trauma","Injury","Iliac","BXB","Aortoiliac occlusive disease","Visceral artery occlusive disease","Iliac arteries","visceral arteries","subclavian artery aneurysms","iatrogenic vessel injuries","FEVAR","BEVAR","CERAB","2026-05-29",{"date":101,"type":102},"2026-06-02","ACTUAL",{"date":104,"type":102},"2026-05-08",{"date":106,"type":72},"2031-01",{"name":5,"class":6},1]