NCT07295145

Bentley Bridging Stent Graft Study

BeFab: An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of Bentley Bridging Stent Graft Systems

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Bentley InnoMed GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This international, observational multi-centre observational study of the devices BeFlared FEVAR Stent Graft System (BeFlared), BeGraft Stent Graft System (BeGraft), and BeGraft Plus Stent Graft System (BeGraft Plus) will monitor technical success of the implantation, data regarding clinical performance, clinical benefit, as well as potential unknown side effects for the use as bridging stent grafts in combination with fenestrated aortic endovascular grafts.

Conditions

• Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	endovascular aortic repair (EVAR)	The primary goal of EVAR is to bypass the aneurysm sac with the aortic endovascular graft. Through isolation of the aneurysm sac, the blood pressure on the affected aortic tissue is reduced. This prevents aneurysm growth, which is otherwise associated with an elevated risk of rupture. As the pressure on the aneurysm sac is minimized, the current risk of rupture is also mitigated. In case that arteries branch off from the aorta in the area of the aneurysm, or at the proximal and distal sealing zones of the endograft, complex EVAR approaches are employed, which include stenting of the aortic branches (mostly renal and visceral arteries, also called target vessels) in addition to implantation of an aortic endovascular graft. A distinction is made between different variants of complex EVAR procedures, which comprise fenestrated endovascular aneurysm repair (FEVAR), branched endovascular aneurysm repair (BEVAR) and hybrid approaches.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-12-01
• Completion: 2031-12-01
• First posted: 2025-12-19
• Last updated: 2025-12-19