Bentley Bridging Stent Graft Study (BeFab)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Aneurysm
• Intervention / Treatment: Device: endovascular aortic repair (EVAR)

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Richard A Griesbach, Dr; Phone Number: +49 7471 9999 117; Email: r.griesbach@bentley.global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients having complex abdominal aortic aneurysms

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target vessel instability at 12 months, defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention	12 months post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedure time		during procedure
Target vessel instability defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention		1 month, 24 months, 36 months, 48 months, and 60 months post index procedure
Procedure-related complications		during procedure, at discharge and 1 month and 12 months post index procedure
Bridging stent-related complications		during procedure, and 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
technical success defined as correct positioning and deployment of bridging stent grafts		during procedure
Primary patency rate defined as uninterrupted patency with no occlusion		1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Secondary patency rate		1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Freedom from secondary procedures		1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Freedom from bridging stent related endoleaks		1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Post-procedure Major adverse event rate		1 month post procedure
Freedom from aneurysm-related death		1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Freedom from aortic aneurysm maximum diameter increase		1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure
Device implantation time		during procedure
total patient radiation dose		during procedure
total time of fluoroscopy		during procedure
total volume of received contrast medium		during procedure
Patient blood loss		during the procedure
duration of ICU stay		1 month post index procedure
duration of total hospital stay		1 month and 12 months post index procedure
mortality rate at 30 days		1 month post index procedure
Quality of life score	EQ5D	1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure

Collaborators and Investigators

• Sponsor: Bentley InnoMed GmbH
• Collaborators: NAMSA

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Vascular Grafting; Prosthesis Implantation; Blood Vessel Prosthesis Implantation; Endovascular Aneurysm Repair
• Other Study ID Numbers: PM08-01 BeFab

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No