Enrollment Begins in Study of CERAB Technique With Bentley’s Covered Stents to Treat AIOD

April 8, 2024—Bentley InnoMed GmbH announced that the first patient was enrolled in an investigator-initiated study on the treatment of aortoiliac occlusive disease (AIOD) with the covered endovascular reconstruction of the aortic bifurcation (CERAB) technique using a combination of the Bentley BeGraft aortic stent graft system and the BeGraft peripheral stent graft system.

According to the company, the CERAB technique with the BeGraft aortic and two BeGraft peripheral stents provides a treatment option for high-risk patients for whom open surgery is unsuitable.

Approximately 16 sites in Germany and the Netherlands will participate in the CERAB study, which will enroll 109 patients with a follow-up period of 24 months. The study, which is approved by the German and Dutch competent authorities, is being conducted by the Foundation for Cardiovascular Research and Education and supported by Bentley.

The first patient in the study was treated by Ioannis Passaloglou, MD, Chief Physician of Vascular Surgery at St. Gertrauden Hospital in Berlin, Germany, who successfully performed the CERAB procedure. Dr. Passaloglou is the coordinating investigator of the multicenter clinical study.

“We are happy to contribute to the clinical investigation on the endovascular treatment of AIOD,” commented Dr. Passaloglou in Bentley’s press release. “The CERAB technique has shown great results so far, and in combination with the Bentley stents, the treatment has major advantages compared to the ‘kissing stent’ technique or the open approach.

“Although the procedure is still off-label, the complication rate is lower and the patients’ recovery faster. Together with further clinical data, it may become the new gold standard for treating AIOD and to increase the patency rates in the long-term.”

Also in the press release, Dr. Martin Schirling, Clinical Affairs Manager at Bentley, advised, “This prospective clinical trial will support the on-label certification of the Bentley BeGraft aortic and BeGraft peripheral for the treatment of AIOD. We assume that it will further prove the long-lasting positive therapeutic effects of the CERAB technique leading to a reduced perioperative mortality and morbidity versus open surgical procedures for patients severely suffering from AIOD.”