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NCT Number: NCT07295145

Bentley Bridging Stent Graft Study

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.

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Key information

Conditions

Aortic Aneurysm Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular Aortic Repair (EVAR)

Device

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Procedure-related complications

    Time frame: during procedure, at discharge and 1 month and 12 months post index procedure

  3. 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

  4. technical success defined as correct positioning and deployment of bridging stent grafts

    Time frame: during procedure

  5. 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

  6. Secondary patency rate

    Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure

  7. Freedom from secondary procedures

    Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure

  8. Freedom from bridging stent related endoleaks

    Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure

  9. Post-procedure Major adverse event rate

    Time frame: 1 month post procedure

  10. Freedom from aneurysm-related death

    Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure

  11. 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

  12. Device implantation time

    Time frame: during procedure

  13. Total procedure time

    Time frame: during procedure

  14. total patient radiation dose

    Time frame: during procedure

  15. total time of fluoroscopy

    Time frame: during procedure

  16. total volume of received contrast medium

    Time frame: during procedure

  17. Patient blood loss

    Time frame: during the procedure

  18. duration of ICU stay

    Time frame: 1 month post index procedure

  19. duration of total hospital stay

    Time frame: 1 month and 12 months post index procedure

  20. mortality rate at 30 days

    Time frame: 1 month post index procedure

  21. Quality of life score

    Time frame: 1 month, 12 months, 24 months, 36 months, 48 months, and 60 months post index procedure

    EQ5D

Study contacts

Contact information is provided by the study sponsor or research team.

Richard A Griesbach, Dr

CONTACT

[email protected]

+49 7471 9999 117

Sponsors and collaborators

Lead sponsor

Bentley InnoMed GmbH

Industry

Collaborators

  • NAMSA

Registry information

Official study title

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

Acronym: BeFab

Important dates

Study start
2026
Primary completion
2027
Study completion
2031
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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