Gore announces clinical study comparing VBX balloon expandable endoprosthesis to bare metal stents

Gore Viabahn VBX balloon expandable endoprosthesis

Gore announced today the initiation of the Gore VBX FORWARD clinical study to compare the VBX stent graft to bare metal stenting for patients with complex iliac occlusive disease.

This prospective, multicentre, randomised controlled trial will include up to 40 sites in the USA, Australia, New sealand and Europe. An estimated 244 subjects will be randomised 1:1 to the VBX stent graft group or the control group (BMS) and will have follow-up visits up to five years from the initial procedure.

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

A cross-specialty physician steering committee, bringing 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.

“There is limited randomised long-term head-to-head outcomes data available to guide stent choice for the treatment of iliac occlusive disease. 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 bare metal stents,” said Melissa Kirkwood (University of Texas Southwestern Medical Center, Dallas, USA) and VBX FORWARD study steering committee member.

“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,” said Michel M.P.J. Reijnen, (Rijnstate, Arnhem, The Netherlands) and VBX FORWARD study steering committee member.

The VBX stent graft offers precise delivery and supports positive outcomes in complex aortoiliac applications. Recently published five-year long-term follow-up aortoiliac occlusive disease (AIOD) clinical data underscores the robustness and durability of the device. The device was developed utilising the small diameter, ePTFE stent graft technology from the GORE VIABAHN Endoprosthesis. The VBX Stent Graft is available in a range of diameters from 5 –11mm and lengths of 15, 19, 29, 39, 59 and 79mm, currently the longest balloon expandable stent graft available, to cover a variety of occlusive disease treatment needs. The VBX stent graft also offers the largest range of diameter adjustability in a single device.


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