Gore Initiates VBX FORWARD Study Comparing Viabahn VBX Stent Graft to Bare-Metal Stents

June 13, 2023—Gore & Associates announced the initiation of the Gore VBX FORWARD clinical study, which is evaluating the company’s Viabahn VBX balloon-expandable endoprosthesis compared to bare-metal stents (BMS) for patients with complex iliac occlusive disease.

According to the company, the prospective, multicenter, randomized controlled trial will include up to 40 sites in the United States, Australia, New Zealand, and Europe. An estimated 244 patients will be randomized 1:1 to the VBX stent graft group or the BMS control group. Follow-up will be conducted up to 5 years from the initial procedure.

The study’s primary endpoint will be primary patency through 1 year. Secondary endpoints will address technical success, acute procedural success, clinical success, additional patency and target lesion revascularization outcomes, and patient improvement metrics. The 1-year results of the study are expected in 2027 and are intended to be published and presented at major congresses thereafter.

A cross-specialty physician steering committee, with a diverse range of practice experience and perspective, has been assembled to provide joint leadership with Gore on the design and execution of this study, advised the company.

Melissa Kirkwood, MD, who is Professor and Chief of Vascular Surgery at University of Texas Southwestern Medical Center in Dallas, Texas, is a member of the VBX FORWARD study steering committee.

“There [are] limited randomized long-term, head-to-head outcomes data available to guide stent choice for the treatment of iliac occlusive disease,” commented Dr. Kirkwood in the company’s press release. “The VBX FORWARD study represents an opportunity to positively impact practice guidelines in this area. 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 BMS.”

Professor Michel M.P.J. Reijnen, MD, a vascular surgeon at Rijnstate in Arnhem, the Netherlands, is also a member of the steering committee. Prof. Reijnen stated in the press release, “Iliac occlusive disease can be challenging to treat, with tortuous anatomy, severe stenosis, and calcified occlusions presenting treatment risks such as perforation and rupture. 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.”

According to the company, the VBX stent graft was developed utilizing the small-diameter expanded polytetrafluoroethylene stent graft technology from the Gore Viabahn endoprosthesis. The VBX stent graft is available in a range of diameters from 5 to 11 mm and lengths of 15, 19, 29, 39, 59, and 79 mm to cover a variety of occlusive disease treatment needs.

Gore noted that in April 2023, long-term (5-year) follow-up clinical data underscoring the robustness and durability of the Viabahn VBX device to treat patients with iliac occlusive disease were published by Andrew Holden, MD, et al online in Journal of Endovascular Therapy.