W L Gore & Associates (Gore) is commencing the EMBRACE Registry as a study of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent Graft).
The prospective, retrospective and multicentre study has been designed to assess the safety and clinical performance of the VBX Stent Graft for use as a bridging stent with a branched/fenestrated stent graft to treat aortic aneurysms involving the renal-mesenteric arteries.
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The study will involve up to 15 sites in Europe, which will each enrol a minimum of 220 participants who have received treatment with the VBX Stent Graft.
The study participants will have five years’ worth of follow-up visits after the initial procedure.
The target vessel patency at 12 months will be the trial’s primary efficacy endpoint.
Other secondary endpoints of the trial will address reinterventions, technical success and target vessel instability from a performance perspective, as well as aneurysm-related mortality and Major Adverse Events from a safety perspective.
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By GlobalDataGore expects to receive one-year results from the trial in the middle of the year.
The VBX Stent Graft was developed using the ePTFE stent graft technology from the GORE VIABAHN Endoprosthesis.
It provides precise delivery and supports positive outcomes in complex aortoiliac applications.
The device is currently offered in diameters of 5mm to 11mm and lengths of 15mm, 19mm, 29mm, 39mm, 59mm or 79mm.
EMBRACE Registry coordinating investigator and Spedali Civili Brescia, Italy, Vascular Surgery associate professor Luca Bertoglio said: “Currently, all stents are used off-label during fenestrated and branched endovascular procedures.
“This study will evaluate the VBX Stent Graft clinical performance and eventually support device indication expansion for on-label use.
“The EMBRACE Registry will track the real-world effectiveness and safety of the device, with minimal inclusion and exclusion criteria, and I look forward to the results and seeing the long-term value of this device.”
