W. L. Gore & Associates announced that it will present the results of the Gore REVISE clinical study, the only randomized, controlled study of stent-grafts to investigate both stenotic and thrombotic occlusive arteriovenous (AV) access patients.
The results showed that the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface is superior to percutaneous transluminal angioplasty (PTA) – the current standard of care for treating stenoses or thrombotic occlusions.
The results of the Gore REVISE Clinical study will be presented at the 10th Annual Scientific Meeting of the American Society of Diagnostic and Interventional Nephrology (ASDIN) in Phoenix.
The multicenter, randomized-controlled trial evaluated the safety and effectiveness of the GORE VIABAHN Endoprosthesis in treating stenoses or thrombotic occlusions of a synthetic AV access graft at the venous anastomosis.
The study compared the results of two patient groups, one treated with the GORE VIABAHN Device and the other receiving PTA.
Key Points from the Gore REVISE Clinical Study:
• Statistical superiority over the PTA group in target lesion primary patency over a 24 month follow-up period (p = 0.008)
• Non-inferiority in terms of freedom from major device, treatment, or procedure related adverse events as compared to the PTA group (p
• Greater primary patency for both thrombotic and non-thrombotic patients as compared to PTA
• A reduction in the number of repeat interventions per patient as compared to the PTA group necessary to maintain access secondary patency
• No reported fractures crossing the elbow
"The results of our study clearly demonstrate the superior clinical benefit of using a stent-graft for AV graft revisions as opposed to PTA alone," said Dr. Tom Vesely, MD, Interventional Radiologist at the Vascular Access Center in Frontenac Grove, Mo., and Medical Director of the Gore REVISE Clinical Study. "In addition to its proven clinical benefit, the GORE VIABAHN Endoprosthesis is both flexible and durable, allowing it to conform to the anatomy of a moving arm and cover every curve. The device provides physicians with an endovascular tool to treat even the most challenging venous anastomotic locations."
The GORE VIABAHN Endoprosthesis is the lowest profile, most flexible, self-expanding, small-diameter, endoprosthesis available and the only stent or stent-graft to receive approval for the superficial femoral artery (SFA), iliac artery, and AV Access. It is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner and attached to an external nitinol stent structure. The ePTFE luminal surface of the GORE VIABAHN Endoprosthesis features the CARMEDA BioActive Surface (CBAS Heparin Surface) for sustained anti-thrombotic bioactivity.
"With the Gore REVISE Clinical Study, we wanted to set out and prove not only that the GORE VIABAHN Endoprosthesis can successfully treat stenoses or thrombotic occlusions, but that the device is superior to the current standard of care," said Ray Swinney, Business Unit Leader for the Gore Peripheral Interventional Business Unit. "Investing in clinical studies such as REVISE allows Gore to provide physicians with superior technology that is supported by trusted clinical data. In doing so, we can help physicians better serve the needs of their patients, particularly those with challenging anatomies that may not have been eligible for stent-graft procedures until now."