NCT06872905

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 158 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed description

A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.

Conditions

• Aortoiliac Occlusive Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-30
• Primary completion: 2027-08-16
• Completion: 2027-08-16
• First posted: 2025-03-12
• Last updated: 2026-03-30

Locations

19 sites across 5 countries: United States, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated device study