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Not yet recruiting NCT07295145

Bentley Bridging Stent Graft Study

— Observational Aortic Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endovascular aortic repair (EVAR).
Who it may be relevant to
Registry conditions: Aortic Aneurysm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 z

Primary outcome measures

  • Target vessel instability at 12 months, defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention [Time frame: 12 months post index procedure]
Secondary outcome measures (12)
  • Target vessel instability defined as bridging stent-specific occlusion, stenosis, endoleak Type Ic/IIIc, or re-intervention [Time frame: 1 month, 24 months, 36 months, 48 months, and 60 months post index procedure]
  • Procedure-related complications [Time frame: during procedure, at discharge and 1 month and 12 months post index procedure]
  • Bridging stent-related complications [Time frame: 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 [Time frame: during procedure]
  • Primary patency rate defined as uninterrupted patency with no occlusion [Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure]
  • Secondary patency rate [Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure]
  • Freedom from secondary procedures [Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure]
  • Freedom from bridging stent related endoleaks [Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure]
  • Post-procedure Major adverse event rate [Time frame: 1 month post procedure]
  • Freedom from aneurysm-related death [Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure]
  • Freedom from aortic aneurysm maximum diameter increase [Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure]
  • Device implantation time [Time frame: during procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07295145 · PM08-01 BeFab

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗