The study compares Gore’s balloon-expandable endoprosthesis to bare metal stenting for patients with complex iliac occlusive disease. It aims to inform practice guidelines around the best modalities suited for patients with this condition.
Dr. Fakhir Elmasri and a team at Lakeland Vascular Institute (Lakeland, Florida) were among the first to enroll patients. Elmasri, an interventional radiologist, said the results should inform device selection for durable outcomes in the future. Dr. Prakash Krishnan at Mount Sinai (New York) said the study could answer the question around superior modalities.
Gore plans to enroll an estimated 244 subjects across 40 sites in the U.S., Australia, New Zealand and Europe. The trial randomizes patients 1:1 for the VBX stent graft group or the bare metal stenting control. According to a news release, the study includes five-year follow-up after the initial procedure.
The VBX stent graft offers precise delivery and supports positive outcomes in complex aortoiliac applications, Gore says.
“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.”