Study Seeks Evidence for On-Label Use of Bentley’s BeGraft Stent for FEVAR

March 19, 2021—Bentley InnoMed GmbH announced that the first patient to undergo fenestrated endovascular aortic repair (FEVAR) with the company’s BeGraft peripheral balloon-expandable covered stent was treated in the open-label BeGraft FEVAR study. According to the company, the study aims to investigate the safety and performance of the BeGraft device as a bridging stent in FEVAR for complex aortic aneurysms.

The study, which is approved by the German Federal Institute for Drugs and Medical Devices, is being run in collaboration with Bentley and the Foundation for Cardiovascular Research and Education. All participating centers in the study are in Germany and include Nuremberg, Münster, Munich, Regensburg, Aachen, Stuttgart, and Giessen.

The BeGraft FEVAR study’s Coordinating Investigator and Lead is Professor Eric Verhoeven, MD, Professor of Vascular Surgery at the General Hospital Nuremberg, Paracelsus Medical University, in Nuremberg, Germany.

According to Prof. Verhoeven, the initial patient was referred for FEVAR with a 6-cm juxtarenal abdominal aortic aneurysm. He commented, “This patient has an absolute indication due to the diameter, and we cannot use standard endovascular aortic repair (EVAR) to seal below the renal arteries because there is no sealing zone available.” Two additional patients are enrolled for treatment in the coming week, noted Prof. Verhoeven.

In the press release, Bentley outlined the study as follows. A total of 100 patients will be included to generate data on approximately 250 to 300 BeGrafts in fenestrations. Recruitment will take 12 months, with 24-month follow-up. The main outcomes will be technical success (successful 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. Initial results of the BeGraft in FEVAR trial are anticipated in mid-2023.

The company noted that all of the numerous covered stents on the market, including BeGraft, are used off-label as bridging stents in FEVAR. However, there is a lack of consensus around what to use, and there is no gold standard or solid evidence to support their use. Prof. Verhoeven stated, “Bentley is the first company to try to obtain an on-label approval for the BeGraft stent in FEVAR and shift from off-label to on-label use.”

Bentley advised that FEVAR is currently a well-established, minimally invasive option for patients with abdominal aortic aneurysms who are not eligible for a traditional EVAR. These patients, who represent approximately 10% of all patients, usually have an aneurysm that is too close to the renal arteries, and until recently, they would require open surgery or no treatment at all. Open surgery is more invasive, and mortality is higher.

In 2016, Prof. Verhoeven et al published results of a study that showed mortality in patients who had undergone FEVAR at his center, General Hospital Nuremberg, was 0.7% (European Journal of Vascular & Endovascular Surgery; 2016;51:775-781). There was also a reduced duration of in-hospital recovery with FEVAR compared to open surgery.

Prof. Verhoeven observed, “For me, it’s clear that the BeGraft has an advantage as it goes into a 6-F guiding sheath rather than a 7-F sheath. The slightly lower profile is important, as a 6-F guiding sheath tracks difficult anatomy better than a 7 F. Also, the BeGraft comes in many lengths and in short intervals, like a 27/28-mm length, which is often ideal for more difficult renal arteries.”

Bentley noted that it is also conducting a prospective, single-arm, multicenter clinical study to obtain an indication for the use of the BeGraft Peripheral Plus as a bridging stent in branched endovascular aortic repair (BEVAR) for the treatment of complex thoracoabdominal aortic aneurysms. This trial began in September 2020 and aims to carry out 100 BEVAR procedures with an average of 2.5 bridging stents per procedure.