W L Gore & Associates today announced that it is initiating the EMBRACE registry to capture real-world data about the Gore Viabahn VBX balloon expandable endoprosthesis used as a bridging stent in conjunction with a branched/fenestrated stent graft.
This multicentre, retrospective and prospective registry is being conducted to evaluate the clinical performance and safety of the VBX stent graft as a bridging stent. Up to 15 sites in Europe will be required to enrol a minimum of 220 patients that have had treatment with the VBX stent graft. These patients will have prospective follow-up visits up to five years from the initial procedure.
The primary efficacy endpoint will be the target vessel patency at 12 months. Other secondary endpoints will address technical success, reinterventions and target vessel instability from a performance perspective, and aneurysm-related mortality and major adverse events from a safety perspective. One-year results of the registry are expected mid-2023 and results are intended to be published and presented at major congresses thereafter.
“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,” said Luca Bertoglio (Spedali Civili Brescia, Brescia, Italy), coordinating investigator of the registry. “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.”
The VBX stent graft offers precise delivery and supports positive outcomes in complex aortoiliac applications, Gore claims in a press release. The device was developed utilising the small diameter, ePTFE stent graft technology from the Gore Viabahn endoprosthesis. The VBX stent graft is available in a range of diameters from 5 to 11mm and lengths of 15, 19, 29, 39, 59 and also 79mm. It also offers a range of diameter adjustability in a single device, with a maximum post-dilated diameter up to 16mm with 8L or 11mm devices.