FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial.

Background: The recommendations for the use of and selection of covered stent grafts in patients with aortoiliac occlusive disease are limited.

Objective: The GORE VBX FORWARD clinical study aims to demonstrate the superiority of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX device) for primary patency when compared to bare metal stenting (BMS) for the treatment of complex iliac artery occlusive disease.

Methods: A prospective, multicenter, randomized control study in the United States, European Union, United Kingdom, Australia, and New Zealand will enroll patients with symptomatic, complex iliac artery occlusive disease.