Gore has announced that the first patients have been enrolled in the Gore VBX FORWARD clinical study, a global prospective, multicentre, randomised 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 enrol patients in this important study,” said Fakhir Elmasri, interventional radiologist at Lakeland Vascular Institute (Lakeland, USA). “Our first patient presented with complex, bilateral iliac disease and was randomised 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 [BMS] remains a source of debate,” added Prakash Krishnan, interventional cardiologist at The Mount Sinai Hospital (New York, USA). “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 enrol an estimated 244 patients across 40 sites in the USA, Australia, New Zealand and Europe, randomising 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, professor and chief of vascular surgery at the University of Texas Southwestern Medical Center in Dallas, USA, 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.”
A Gore press release details that the VBX stent graft offers precise delivery and supports positive outcomes in complex aortoiliac applications. It details that 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.
“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 at Gore when the news was released on 16 January. “Not only can the results from this randomised 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.”
