GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)
Key facts
- Where
- Munich, GermanySee the site
Where in Germany
- TUM KlinikumMunich, GermanyContact: Cagla SelvanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- W.L.Gore & Associates
- Trial code
- NCT07279649
- Record updated
- 2 June 2026
- Original description
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)Read full original descriptionShow less
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)
Inclusion: Age ≥18 years; Informed Consent Form (ICF) is signed by subject; Suitable for endovascular treatment with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) device; Willingness of the subject to adhere to institutional standard of care follow-up requirements.
Exclusion: 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); Participation in concurrent research study or registry which may confound registry results, unless approved by Gore; Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II; Known intolerance to anticoagulant and / or antiplatelet therapy at the time of the index procedure; 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; Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders); Life expectancy <12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites; Pregnant or breast-feeding subject at time of informed consent signature.