W. L. Gore and Associates (Gore) has begun a clinical trial to compare the Gore VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) to bare metal stenting in patients with complex iliac occlusive disease.
The Gore VBX FORWARD study will enrol patients at up to 40 sites in Australia, New Zealand, Europe and the US.
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The multicentre, prospective controlled study will randomise 244 subjects in a 1:1 ratio to the VBX Stent Graft group or the control group.
Upon completion of the initial procedure, follow-up visits will be carried out for up to five years, with primary patency through one year being the primary endpoint of the study.
Acute procedural success, clinical success, technical success, patient improvement metrics, additional patency and target lesion revascularisation outcomes are the secondary endpoints.
The company is expected to reveal one-year results from the trial in 2027.
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By GlobalDataVBX FORWARD Study steering committee member Melissa Kirkwood said: “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.”
The company has developed the VBX Stent Graft to enable accurate delivery and support positive outcomes in complex aortoiliac applications.
The device was created using the small diameter ePTFE stent graft technology from the GORE VIABAHN Endoprosthesis.
It comes in various diameters ranging from 5mm to 11mm and 15, 19, 29, 39, 59 and 79mm lengths.
Gore medical products division peripheral business leader Jill Paine said: “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.”
