Clinical Trial

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

Recruiting
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Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-03-30; most recent amendment 2026-05-11.
Status change: Not Yet Recruiting → Recruiting 2023-11-07
Trial Details
NCT Number NCT05811364
Lead Sponsor W.L.Gore & Associates
Conditions Aortoiliac Occlusive Disease, Peripheral Arterial Disease
Enrollment 244 participants
Start Date 2023-10-17
Primary Completion 2028-03-30 (estimated)
Study Completion 2032-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-13