NCT05811364

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortoiliac Occlusive Disease
• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis	Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
DEVICE	Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent	Treatment of target lesions in the common and/or external iliac arteries by stenting with a commercially available bare metal stent that is approved for treatment of the disease.

Timeline

• Start date: 2023-10-17
• Primary completion: 2028-03-30
• Completion: 2032-01-31
• First posted: 2023-04-13
• Last updated: 2025-04-16

Locations

7 sites across 4 countries: United States, Germany, Netherlands, New Zealand

Regulatory

• FDA-regulated device study