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The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 7 to 43v5
  2. Primary completion date: Apr 30, 2027 to Mar 30, 2028
    • Study sites: 8 to 7
    • Study completion date: Apr 30, 2031 to Jan 31, 2032
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 7 to 8
    • Start date changed from estimate of Jul 31, 2023 to Oct 17, 2023
    v3
  4. Site contacts updated at 1 of 7 sitesv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
Trial Details
NCT Number NCT05811364
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Aortoiliac Occlusive Disease, Peripheral Arterial Disease
Related terms Peripheral Arterial Disease
Enrollment 244 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov