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

NCT07279649 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2026-02-05

No results posted yet for this study

Summary

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)

Conditions

  • Aorto-iliac Occlusive Disease (AIOD)
  • Visceral Artery Occlusive Disease (VAOD)
  • Isolated Artery Aneurysms (IAA)
  • Trauma or Iatrogenic Vessel Injury

Interventions

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.

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Daniele Branzan, Prof. Dr. · TUM Klinikum

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2031-01-31
Completion
2031-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07279649 on ClinicalTrials.gov