Recruitment is now complete with more than 100 patients as planned per protocol in the branched endovascular aortic aneurysm repair (BEVAR) study that uses Bentley's BeGraft peripheral PLUS balloon expandable covered stent (Bentley InnoMed, Hechingen, Germany) as a bridging stent in complex aortic aneurysms repairs.
Sebastian Büchert (CEO, Bentley) mentioned, “At Bentley we became aware that a significant share of the BeGraft peripheral PLUS is being used as a bridging stent for the treatment of thoracoabdominal aneurysms in BEVAR procedures. Since none of the available covered stents are holding this indication, Bentley aims to step up and bring this off-label application on-label.”
The study, which is led by Dr. Martin Austermann, Surgeon of Vascular Surgery at the St. Franziskus Hospital in Münster, Germany, is evaluating the safety and performance of the BeGraft peripheral PLUS as a bridging stent in BEVAR procedures. When successful, this would bring the on-label use in this indication a step closer.
Dr. Austermann explained: "In BEVAR interventions, bridging stents are not supported by the native vessel wall, so the risk of failure is high. Although we have not yet analysed study data, the BeGraft peripheral PLUS with its special design met the requirements of high radial force combined with flexibility quite well. At first glance the data is promising, and with the potential indication for on-label usage as a bridging stent in BEVAR procedures, it will change the approach from the physicians' perspective."
The study endpoints include technical success of the procedure and patency of the bridging stent after one year. Safety will be evaluated for the one-year time point and will include the absence of procedure related complications and endoleaks associated with the bridging stents. Results are expected in the second half of 2024.
The study is a collaboration between the Foundation for Cardiovascular Research and Education (FCRE, Belgium) and Bentley. It has been approved by the German competent authority BfArM. Participating German centres are the St. Franziskus Hospital Münster, University Hospitals Aachen, University Clinic Hamburg-Eppendorf, LMU Munich, University Clinic Regensburg, Stuttgart Hospital, University Hospital Leipzig, University Hospital Heidelberg, University Hospital Schleswig-Holstein-Kiel and the Nuremberg Hospital.
ClinicalTrials.gov Identifier: NCT03982940
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