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Bentley Bridging Stent Graft Study

NCT07295145 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-12-19

No results posted yet for this study

Summary

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.

Conditions

  • Aortic Aneurysm

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 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.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Bentley InnoMed GmbH

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-12-31
Completion
2031-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07295145 on ClinicalTrials.gov