[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614442":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":46,"studyPopulation":47,"armGroups":48,"interventions":66,"overallOfficials":72,"centralContacts":77,"locations":87,"responsibleParty":100,"collaborators":42,"id":102,"slug":42,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":42,"eligibilityCriteria":106,"healthyVolunteers":103,"sex":107,"minAge":108,"maxAge":42,"enrollmentInfo":109,"targetDuration":112,"studyType":113,"phases":42,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":89,"whyStopped":42,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"W.L.Gore & Associates","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":42},[9,13],{"measure":10,"description":11,"timeFrame":12},"Freedom from device-related Serious Adverse Event (SAE) for patients treated with BXB device","No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort","within 30 days after the treatment",{"measure":14,"description":15,"timeFrame":16},"Procedural Success for patients treated with BXB device","Successful access, delivery and deployment of BXB device, and withdrawal of catheters with patent BXB device at end of procedure","at the time of implant",[18,22,25,27,30,33,37,39],{"measure":19,"description":20,"timeFrame":21},"Primary patency for patients treated in Aortoiliac Occlusive Disease (AIOD) through 1 year follow-up","Blood flow through the target vessel without the need for repeat surgical or endovascular procedures","from the time of the index procedure up to 365 days (±window, between days 335 and 455)",{"measure":23,"description":24,"timeFrame":21},"Freedom from major amputation of the BXB device treated limb for patients treated in AIOD","No amputation above the transmetatarsal level of the treated limb",{"measure":26,"description":20,"timeFrame":21},"Primary patency for patients treated in Visceral Occlusive Disease (VAOD)",{"measure":28,"description":29,"timeFrame":21},"Survival for patients treated in VAOD","Patient is free from death of any cause (is alive)",{"measure":31,"description":32,"timeFrame":21},"Freedom from reintervention through 1 year follow-up for patients treated in Isolated Artery Aneurysm (Subclavian, Visceral, Iliac)","Freedom from unanticipated interventions on the target vessel(s) treated with the BXB Device.",{"measure":34,"description":35,"timeFrame":36},"30 Day Mortality for patients treated in IAA","all deaths, regardless of their relationship to the device, procedure, aneurysm, or unrelated medical conditions.","from the time of the index procedure through 30 days",{"measure":38,"description":20,"timeFrame":21},"Treated vessel primary patency through 1 year follow-up for patients treated Trauma or Iatrogenic Vessel Injury",{"measure":40,"description":41,"timeFrame":21},"Device-related adverse events (i.e. thrombosis) for patients treated in Trauma or or Iatrogenic Vessel Injury","Stent thrombosis deemed to be device related as assessed by the Investigator.",null,{"allocation":42,"interventionModel":42,"interventionModelDescription":42,"primaryPurpose":42,"observationalModel":44,"timePerspective":45,"maskingInfo":42},"COHORT","PROSPECTIVE","This is a prospective, multicenter, observational registry to collect real world data of the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) device.\n\nThe registry population will include subjects presenting with clinical conditions consistent with the BXB device indications for use and in accordance with standard of care. The following subject cohorts will be included in the registry:\n\n* De novo or restenotic lesions in the iliac arteries including lesions at the aortic bifurcation \\[Aortoiliac occlusive disease (AIOD)\\],\n* De novo or restenotic lesions in the visceral arteries \\[Visceral artery occlusive disease (VAOD)\\],\n* Isolated visceral, iliac, and subclavian artery aneurysms \\[IAA\\], or\n* Traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) \\[Arterial Injury (AI)\\].\n\nTo satisfy a key objective of the PMCF plan, clinical data will be collected in other indications outside of those listed above (Other cohort).\n\nApproximately 24 clinical investigative sites in Europe, will participate in this registry. 240 subjects will be implanted in this study with a limit of 48 subjects treated \u002F implanted per site. If a site reaches 48 subjects, enrolment will be closed for that site. All subjects will be followed through 12 months (1 year) post-procedure per standard of care. Quality of Life questionnaires will also be collected for all follow-up visits.","The registry population will include subjects presenting with clinical conditions consistent with the BXB device indications for use and in accordance with standard of care. The following subject cohorts will be included in the registry:\n\n* Aortoiliac occlusive disease (AIOD)\n* Visceral artery occlusive disease VAOD)\n* Isolated visceral, iliac, and subclavian artery aneurysms \\[IAA\\]\n* Traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) \\[Arterial Injury (AI)\n* To satisfy a key objective of the PMCF plan, clinical data will be collected in other indications outside of those listed above (Other cohort) The registry has been designed with standard eligibility criteria to enroll subjects for which the registry device is intended to treat. Only subjects who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled.",[49,54,57,60,63],{"label":50,"type":42,"description":51,"interventionNames":52},"Aortoiliac Occlusive Disease: De novo or rest. lesions in the iliac arteries include aortic bifurcat","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.",[53],"Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)",{"label":55,"type":42,"description":51,"interventionNames":56},"Visceral Artery Occlusive Disease (VAOD): De novo or restenotic lesions in the visceral arteries",[53],{"label":58,"type":42,"description":51,"interventionNames":59},"Isolated Artery Aneurysmal Disease (IAA): Isolated visceral, iliac, and subclavian artery aneurysms",[53],{"label":61,"type":42,"description":51,"interventionNames":62},"Trauma or Iatrogenic Vessel Injury: are located in the chest cavity, abdominal cavity, or pelvis",[53],{"label":64,"type":42,"description":51,"interventionNames":65},"Other (subjects not fitting into the categories above)",[53],[67],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":42},"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.",[50,58,64,61,55],[73],{"name":74,"affiliation":75,"role":76},"Daniele Branzan, Prof. Dr.","TUM Klinikum","PRINCIPAL_INVESTIGATOR",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":42,"email":82},"Cagla Selvan","CONTACT","+31 627 294 665","cselvan@wlgore.com",{"name":84,"role":80,"phone":85,"phoneExt":42,"email":86},"Valerie Jeans","+33(0)6 74 74 26 98","vjean@wlgore.com",[88],{"facility":75,"status":89,"city":90,"state":42,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":42},"RECRUITING","Munich","81675","Germany","DE",{"type":95,"coordinates":96},"Point",[97,98],11.57549,48.13743,{"lat":98,"lon":97},{"type":101,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","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":110,"type":111},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)",[116,117,118,119],"Aorto-iliac Occlusive Disease (AIOD)","Visceral Artery Occlusive Disease (VAOD)","Isolated Artery Aneurysms (IAA)","Trauma or Iatrogenic Vessel Injury",[121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137],"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":140,"type":141},"2026-06-02","ACTUAL",{"date":143,"type":141},"2026-05-08",{"date":145,"type":111},"2031-01",{"name":5,"class":6},1]