W. L. Gore & Associates, Inc. (Gore) announced today that the first patients have been enrolled in the Gore VBX FORWARD Clinical Study (NCT05811364), 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 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.
The VBX Stent Graft offers precise delivery and supports positive outcomes in complex aortoiliac applications. 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, 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."
The GORE VIABAHN Device family of covered stent grafts, inclusive of the VBX Stent Graft and the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface, offers the flexibility and conformability to safely and confidently address even the most complex cases.