Sam Brusco, Associate Editor01.16.24
W.L. Gore & Associates (Gore) enrolled the first patients in its Gore VBX FORWARD clinical study to compare its VIABAHN VBX balloon expandable endoprosthesis (VBX Stent Graft) to bare metal stenting for patients with complex iliac occlusive disease.
The study seeks to enroll about 244 subjects across 40 sites in the U.S., Australia, New Zealand, and Europe, randomized 1:1 to the VBX stent graft group or control group (BMS) and conduct follow-up visits through five years from the first procedure.
Gore said recently published long-term follow-up of patients treated with the VBX Stent Graft for aortoiliac occlusive disease (AIOD) shows the device’s robustness and durability through five years.
"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. "This trial is designed to answer the question as to whether covered stents are the superior modality among commonly used devices in contemporary practice."
"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," added 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."
Gore first revealed the VBX FORWARD study in June.
The study seeks to enroll about 244 subjects across 40 sites in the U.S., Australia, New Zealand, and Europe, randomized 1:1 to the VBX stent graft group or control group (BMS) and conduct follow-up visits through five years from the first procedure.
Gore said recently published long-term follow-up of patients treated with the VBX Stent Graft for aortoiliac occlusive disease (AIOD) shows the device’s robustness and durability through five years.
"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. "This trial is designed to answer the question as to whether covered stents are the superior modality among commonly used devices in contemporary practice."
"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," added 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."
Gore first revealed the VBX FORWARD study in June.