The FORWARD study evaluates the methods in the treatment of complex iliac occlusive disease. Gore’s prospective, multicenter, randomized controlled trial includes up to 40 sites in the U.S., Australia, New Zealand and Europe. The company estimates a total of 244 subjects randomized 1:1 between VBX stent graft and the bare metal stent control. Patients follow-up spans up to five years from the initial procedure.
Gore defines the primary endpoint as primary patency through one year. Secondary endpoints address technical success, acute procedural success, clinical success and additional patency. They also look at target lesion revascularization outcomes and patient improvement metrics.
The company expects one-year results in 2027.
Gore seeks head-to-head data
Dr. Melissa Kirkwood of the University of Texas Southwestern Medical Center said limited long-term head-to-head data exists to guide stent choice for iliac occlusive disease. Kirkwood serves on the VBX FORWARD study steering committee.
“The VBX FORWARD Study represents an opportunity to positively impact practice guidelines in this area,” Kirkwood said. “I look forward to seeing and sharing the data on the full range of clinical scenarios where the VBX stent graft may offer an advantage over bare metal stents.
VBX offers precise delivery and supports positive outcomes in complex aortoiliac applications, Gore says. It comes in a range of diameters from 5 mm to 11 mm, plus lengths of 15, 19, 29, 39, 59 and 70 mm. Gore said it marks the longest balloon expandable stent graft available. The company also said it has the largest range of diameter adjustability in a single device.
“Covered stents are an integral tool for decreasing the risk of complications in these complex cases and delivering durable outcomes, and the VBX FORWARD Study is thoughtfully designed to further explore those advantages,” said Dr. Michel M.P.J. Reijnen, vascular surgeon, Rijnstate Arnhem, The Netherlands and VBX FORWARD study steering committee member.