Gore has announced that the first patients have been enrolled in the Gore VBX FORWARD clinical study, a global prospective, multicenter, randomized controlled trial to compare the Gore Viabahn VBX balloon expandable endoprosthesis (VBX stent graft) to bare metal stenting for patients with complex iliac occlusive disease.
The trial aims to enroll an estimated 244 patients across 40 sites in the U.S., Australia, New Zealand and Europe, randomizing them 1:1 to the VBX stent graft group or the control group (BMS) and conduct follow-up visits through five years from the initial procedure.
“Treating complex iliac occlusive disease often comes with significant challenges, including tortuous anatomy and calcified lesions with the potential for rupture,” remarked Melissa Kirkwood, MD, professor and chief of vascular surgery at the University of Texas Southwestern Medical Center in Dallas, Texas, and study steering committee member. “The outcomes of this important trial will help determine whether the VBX stent graft, with its unique and versatile design, plays a meaningful role in addressing these challenges.”
A Gore press release details that the VBX stent graft offers precise delivery and supports positive outcomes in complex aortoiliac applications. It states that recently published long-term follow-up of patients treated with the stent graft for aortoiliac occlusive disease (AIOD) demonstrates the robustness and durability of the device through five years.
