Bentley Bridging Stent Graft Study (BeFab)

Bentley InnoMed

Status: Not yet enrolling

Conditions: Aortic Aneurysm

Treatments: Device: endovascular aortic repair (EVAR)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07295145

PM08-01 BeFab

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients having complex abdominal aortic aneurysms suitable for an endovascular repair with a fenestrated and/or branched aortic endovascular graft in combination with one Bentley bridging stent graft per reno-visceral artery in accordance with the IFU of BeFlared, BeGraft or BeGraft Plus. Use of different products for different target vessels is allowed. Use of stents from other manufacturers for other reno-visceral arteries is allowed.
• Patient is capable and willing to sign the informed consent and agrees to fulfil follow-up requirements
• Patients ≥18 years of age at the time of consent

Exclusion criteria

• Patients with contraindications as listed in the IFUs
• Previous stenting of the target vessel
• Extension/relining of Bentley BSGs
• Prior EVAR procedure