NCT07295145|Not Yet Recruiting
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
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BeFab
BeFab: An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of Bentley Bridging Stent Graft Systems
Sponsor study identifier
observational
150
0 countries
N/A
Study Start
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 3, 2025
Actual (reported)December 19, 2025
Actual (reported)January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adult patients having complex abdominal aortic aneurysms
First Submitted
December 3, 2025
First Posted
December 19, 2025
Study Start
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2027
EstimatedReady for Recovery Pilot Trial
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 19, 2025
Record last verified: 2025-10
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Source: ClinicalTrials.gov.
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