Bentley Bridging Stent Graft Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Richard A Griesbach, Dr

Role: CONTACT

Phone: +49 7471 9999 117

Email: [email protected]

Other Identifiers

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PM08-01 BeFab

Identifier Type: -

Identifier Source: org_study_id