Bentley’s Study of BeGraft Peripheral Bridging Stent in FEVAR Completes Enrollment

July 21, 2022—Germany-based Bentley InnoMed announced that recruitment has been completed in the BGP Stent as Bridging Stent in FEVAR study.

The study is evaluating the safety and performance of fenestrated endovascular aortic aneurysm repair (FEVAR) using the company’s BeGraft peripheral balloon-expandable covered stent as a bridging stent in complex aortic aneurysms.

None of the commercially available covered stents are currently indicated as a dedicated bridging stent in FEVAR procedures, advised the company. The study is being conducted to bring on-label use in this indication a step closer, stated Bentley.

The open-label study has enrolled 100 patients as planned per the study’s protocol. The study is led by Professor Eric Verhoeven, MD, who is Professor of Vascular Surgery at the General Hospital Nuremberg, Paracelsus Medical University, in Nuremberg, Germany.

The study’s two performance endpoints include technical success of the procedure and bridging stent patency after 1 year. Safety will be evaluated at 1 year that will comprise the absence of procedure-related complications and bridging stent–related endoleaks. The 1-year results are expected during the second half of 2023, advised Bentley.

According to the company, the study is a collaboration between the Foundation for Cardiovascular Research and Education (Belgium) and Bentley and is approved by the German competent authority BfArM, the Federal Institute for Drugs and Medical Devices.

The German participating centers are the University Hospitals Aachen; University Clinic of Gießen & Marburg; University Clinic Hamburg-Eppendorf; LMU Munich; University Clinic Regensburg; University Heart Center Freiburg-Bad Krozingen; St. Franziskus Hospital Münster; Stuttgart Hospital; and Nuremberg Hospital.

Prof. Verhoeven, who has used bridging stents for more than 20 years at his Nuremberg clinic, commented in the company’s press release, “We already know the patency is very good with the BeGraft as bridging stent, and we know how to handle this device. Although we have not yet analysed the data, I’m not expecting any surprises other than the confirmation that the Bentley BeGraft covered stents do well in this indication.”

Regarding the potential on-label approval of the BeGraft peripheral in this context, Prof. Verhoeven stated, “If you can use something on label, many surgeons, particularly in relation to hospital policy, and in relation to the legal ramifications, would not, out of choice, use an off-label product.”