The materials science company has defined the study’s primary endpoint as primary patency through one year, while secondary endpoints will address technical success, acute procedural success, clinical success, and additional patency among others
A product image of GORE VIABAHN VBX balloon expandable endoprosthesis. (Credit: PR Newswire/ W. L. Gore & Associates, Inc. MPD Division)
US-based W. L. Gore & Associates (Gore) has started the Gore VBX FORWARD clinical study to evaluate the Gore Viabahn VBX balloon expandable endoprosthesis (VBX Stent Graft) against bare metal stents (BMS) in patients having complex iliac occlusive disease.
According to Gore, the prospective, multicentre, randomised controlled trial will include up to 40 sites in Australia, the US, New Zealand, and Europe.
The materials science company will randomise 244 subjects in a ratio of 1:1 between the VBX Stent Graft group and the BMS control group. The patients’ follow-up will be conducted up to five years from the initial procedure.
Gore has defined the study’s primary endpoint as primary patency through 12 months.
Secondary endpoints will be addressing technical success, acute procedural success, clinical success, and additional patency. They will also target lesion revascularisation outcomes and patient improvement metrics.
The materials science firm expects one-year results from the VBX FORWARD study in 2027.
For the design and execution of the study, Gore has assembled a cross-speciality physician steering committee.
The VBX Stent Graft is said to offer precise delivery and supports positive outcomes in complex aortoiliac applications. It comes in a range of diameters from 5mm to 11mm, plus lengths of 15, 19, 29, 39, 59, and 79mm.
Gore claimed that VBX Stent Graft is the longest balloon expandable stent graft available and can support a range of occlusive disease treatment needs. It also has the largest range of diameter adjustability in a single device.
The device was developed using the small diameter, ePTFE stent graft technology from the GORE VIABAHN Endoprosthesis.
Gore medical products division peripheral business leader Jill Paine said: “Long-term durability and patient outcomes are the cornerstone of research, development and data generation initiatives across the Gore Medical Products Division.
“The VBX FORWARD Study is an important step in our continuing efforts to raise the bar for endovascular treatment outcomes that can positively impact patient lives.
“We hope the results drive much-needed clarity in the iliac occlusive disease treatment algorithm and associated practice guideline recommendations.”