Early Results from the BeSafe Multicentre Prospective Study Evaluating a New Dedicated Bridging Stent for Fenestrated Endovascular Aneurysm Repair.

Abstract

This study aimed to report the early outcomes of fenestrated endovascular aneurysm repair (FEVAR) performed with the BeFlared bridging stent (Bentley, Hechingen, Germany), a new dedicated bridging stent mounted on a stepped balloon. The study included consecutive patients treated by FEVAR exclusively performed with BeFlared as the bridging stent at 11 high volume centres between November 2024 and April 2025. Patient demographics, target vessel (TV) anatomy, and post-operative patient and stent outcomes were collected prospectively in an electronic database. Computed tomography angiography (CTA) imaging was performed within the first post-operative month. The composite primary endpoint was the freedom from target vessel instability (TVI) rate. Eighty-four patients were included (75 men, 73.2 ± 7.3 years). TV catheterisation failed in two of 312 (0.6%) TVs. BeFlared stenting was successful in all cases after TV catheterisation (n = 310). During the procedure, 13 BeFlared stents (4.2%) required secondary inflation and additional stents were implanted in six TVs (1.9%). The mean procedural time was 162 ± 60 minutes. On completion angiography, all stents were patent and one renal type Ic endoleak was noted (0.3%). Post-operative CTA confirmed the intra-operative type Ic endoleak (0.3%), which is pending re-intervention, and additionally revealed one renal stent stenosis (0.3%). There were no stent occlusions, kinking, fracture, or stent related secondary procedures, resulting in a 99.3% freedom from TVI at one month. In this first multicentre, prospective clinical report involving 84 patients treated across 11 expert centres, the BeFlared bridging stent demonstrated favourable early safety and effectiveness.