Bentley’s BeGraft Peripheral Stent Graft System Studied to Gain On-Label Indication for FEVAR

November 8, 2021—Bentley InnoMed GmbH announced that patient enrollment in a study of the safety and performance of the company’s BeGraft peripheral stent graft system as a dedicated bridging stent for fenestrated endovascular aneurysm repair (FEVAR) procedures for complex aortic aneurysms.

In March 2021, the company announced the commencement of the BGP FEVAR study, which is designed to provide clinical evidence for on-label use in this indication. Since then, more than 50 patients have been enrolled in the study. A complete cohort of 100 patients will be included in the study to generate data on approximately 250 to 300 BeGraft devices in fenestrations. Recruitment is expected to be completed in the first quarter of 2022 with 24 months of follow-up.

All participating centers in the study are in Germany and include Nuremberg, Münster, Munich, Regensburg, Aachen, Stuttgart, and Giessen.

The coordinating investigator and study lead is Professor Eric Verhoeven, MD, who is Professor of Vascular Surgery at the General Hospital Nuremberg, Paracelsus Medical University, Nuremberg, Germany. To date, the majority of patients have been treated in Nuremberg by Prof. Verhoeven, and by Professor Nikolaos Tsilimparis, MD, at Klinikum der Universität München.

“Recruitment has been excellent so far,” commented Prof. Verhoeven in the company’s announcement. “Study investigators and patients have grasped the opportunity to help build an evidence base to support use of this intervention. To date, over 50 patients have been recruited from nine centers across Germany. If we continue at this pace, we are confident that we will complete patient enrolment in the first quarter of the coming year.”

Prof. Verhoeven continued, “The Bentley BeGraft stent fills an unmet medical need in the treatment of complex aortic aneurysms. FEVAR is currently a well-established, minimally invasive option for people with abdominal aortic aneurysms who are not eligible for a traditional endovascular aortic aneurysm repair, but the usage of the bridging stents has always been done off-label in these procedures.”

According to Bentley, the study’s main outcomes will be technical success of device introduction and deployment, bridging stent patency at 12 months, and the absence of procedure-related complications and bridging stent–related endoleaks at 12 months. Overall clinical outcomes including 30-day mortality, and health-related quality of life will also be assessed alongside adverse events.

The study, which is approved by the German Federal Institute for Drugs and Medical Devices, is being run by the Foundation for Cardiovascular Research and Education (FCRE) in collaboration with Bentley.

The company advised that FCRE is also conducting a prospective, single-arm, multicenter clinical study in collaboration with Bentley to obtain an indication for the use of the BeGraft peripheral plus stent graft system as a bridging stent in branched endovascular aortic repair (BEVAR) for the treatment of complex thoraco-abdominal aortic aneurysms. The trial aims to perform 100 BEVAR procedures with an average of 2.5 bridging stents per procedure. Bentley announced the beginning of the BGP+ BEVAR trial in September 2020.