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Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease

NCT06872905 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 158

Last updated 2026-03-30

No results posted yet for this study

Summary

The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).

Conditions

  • Aortoiliac Occlusive Disease

Interventions

DEVICE

GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Leigh Ann O'Banion, M.D. · University of California, San Francisco

  • Michele Antonello, M.D. · Azienda Ospedaliero-Universitaria di Padova

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-30
Primary Completion
2027-08-16
Completion
2027-08-16
FDA Device
Yes

Countries

  • United States
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

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 NCT06872905 on ClinicalTrials.gov