First Patients Enrolled in Study Comparing Stents for Complex Iliac Occlusive Disease

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.

"Our team is pleased to be among the first to enroll patients in this important study," said Fakhir Elmasri, MD, Interventional Radiologist, Lakeland Vascular Institute, Lakeland, Florida. "Our first patient presented with complex, bilateral iliac disease and was randomized to treatment with VBX Stent Grafts. I look forward to seeing the results of the study to inform device selection for durable outcomes in the future."

"While stenting is common when treating complex iliac occlusive disease, the question around whether to use a covered or bare metal stent remains a source of debate," said Prakash Krishnan, MD, Interventional Cardiologist, The Mount Sinai Hospital, New York City. "This trial is designed to answer the question as to whether covered stents are the superior modality among commonly used devices in contemporary practice."

The VBX FORWARD Study aims to enroll an estimated 244 subjects across 40 sites in the United States, 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," said Melissa Kirkwood, MD, Professor and Chief of Vascular Surgery, University of Texas Southwestern Medical Center, Dallas, Texas and VBX FORWARD 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."

The VBX Stent Graft offers precise delivery and supports positive outcomes in complex aortoiliac applications.¹ Recently published long-term follow-up of patients treated with the VBX Stent Graft for aortoiliac occlusive disease (AIOD) demonstrates the robustness and durability of the device through five years.¹

"Today marks important progress in our continuing effort to raise the bar on endovascular treatment outcomes that demonstrate a positive impact on the lives of patients who suffer from this disease," said Eric Zacharias, Medical Products Division Leader, W. L. Gore & Associates. "Not only can the results from this randomized controlled trial help determine which stent choice demonstrates better patency in patients with complex iliac occlusive disease, but it also aims to provide the quality of evidence necessary to inform practice guideline recommendations."

1. Holden A, Takele E, Hill A, et al. Long-term follow-up of subjects with iliacocclusive disease treated with the Viabahn VBX Balloon-ExpandableEndoprosthesis. Journal of Endovascular Therapy. In press.