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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

VBX 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.”