GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorW.L.Gore & Associates

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Life expectancy <12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites.

Trial design

Treatments tested in this trial

  • Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)

Treatment groups

240 Participants
are divided into 5 treatment groups

Sponsors and collaborators