Prospective, Multicentre Physician Initiated Trial Investigating the BeGraft Stent Graft as Bridging Stent in Fenestrated Endovascular Aortic Repair for Complex Aortic Aneurysms.

Abstract

To report the early results of a physician initiated clinical trial evaluating the safety and performance of the BeGraft Stent Graft (Bentley InnoMed, Hechingen, Germany) in fenestrated endovascular aortic aneurysm repair (FEVAR). This prospective, multicentre, single arm, physician initiated trial enrolled patients undergoing FEVAR for complex aortic aneurysms between March 2021 and July 2022 in nine high volume German centres. The BeGraft Stent Graft was used outside its initial intended use as a bridging stent graft (BSG) for FEVAR. The primary endpoints were technical success, BSG patency, and absence of procedure related complications and BSG related endoleaks at 12 months. One hundred and three patients were prospectively enrolled. Three hundred and fifty BSGs were implanted as investigational devices and were included in the analysis. Technical success was 98.3%. Two BSG occlusions were reported in the first 12 months. Primary patency at 12 months was 99.3%. The absence of procedure related complications was 88.3%. Freedom from BSG related endoleaks at 12 months was 99.6%. Freedom from BSG related re-interventions was 97.1%. Two device deficiencies occurred in two patients: one disconnection between the BSG and the balloon before deployment, and one BSG fracture at one year. No BSG migration > 10 mm was recorded during the trial period. This study demonstrated favourable short term outcomes of the BeGraft Stent Graft as a BSG in FEVAR with good primary patency and low rates of BSG related complications.