September 21, 2020
First Patient Recruited in Trial to Obtain Indication for Bentley BeGraft Peripheral Plus in BEVAR
September 21, 2020—Bentley announced the recruitment of the first patient into a trial investigating the company’s BeGraft Peripheral Plus stent graft system as a bridging stent in branched endovascular aortic repair (BEVAR) for the treatment of complex aortic aneurysms.
According to the company, this prospective, single-arm, multicenter clinical trial will be the first trial dedicated to the on-label use of a bridging stent in BEVAR procedures.
The BeGraft Plus, launched in Europe in 2018, combines high radial force and flexibility and is kink-resistant. The system includes two layers of microporous expanded polytetrafluoroethylene (ePTFE) tubing based on two cobalt-chromium stents. It has a “sandwich” design wherein the outer ePTFE layer provides fixation of the outer stent, guarantees sealing properties, protects the inner layer, and prevents endoleaks, while the inner ePTFE layer seals the aneurysm and the inner stent supplies fixation of the inner and outer ePTFE layers.
The trial will include patients seeking elective repair of thoracoabdominal aortic aneurysm with BEVAR and aims to perform 100 BEVAR procedures using an average of 2.5 bridging stents per procedure.
The primary efficacy endpoint is technical success, defined as the successful introduction and deployment of the BeGraft Plus as a bridging stent in BEVAR, and at 12 months, bridging stent patency (absence of restenosis [≥ 50% stenosis]) or sole target vessel occlusion based on CTA. The primary safety endpoint is the absence of procedure-related complications and bridging stent–related endoleaks at 12 months.
“Until now, we have not had a dedicated indicated bridging stent to connect branched endografts with renal and visceral arteries. There are many devices that could be used for this, but all in an off-label setting,” commented Coordinating Investigator Professor Martin Austermann in the press release.
He continued, “It’s great news that we could start a trial in collaboration with the Foundation for Cardiovascular Research and Education and Bentley for this indication, it has been an unmet need for such a long time.” Prof. Austermann is a vascular surgeon at St. Franziskus Hospital and Assistant Professor of Vascular Surgery, University of Münster, in Münster, Germany.