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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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 25 to 26v8
  2. Trial sites expanded: 19 → 25 locationsv7
  3. Study sites: 18 to 19v6
  4. Study sites: 8 to 18v5
  5. Study sites: 6 to 8v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 3 to 6v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 3
    • Start date changed from estimate of May 26, 2025 to May 30, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06872905
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Aortoiliac Occlusive Disease
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov