NCT05805111

Prospective, Non-Randomised Clinical Trial to Investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System Treating Aortic-iliac Occlusive Disease

CERAB - Prospective, Non-Randomised Clinical Trial to Investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System Treating Aortic-iliac Occlusive Disease With CERAB

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 109 (estimated)
• Sponsor: Marc Bosiers, MD · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, investigational study to evaluate safety and performance of the BeGraft Aortic balloon expandable covered Stent Graft System and the BeGraft Peripheral balloon expandable covered stent Graft System (Bentley InnoMed GmbH, Hechingen, Germany) implanted as covered stents in CERAB procedures (Covered Endovascular Reconstruction of Aortic Bifurcation) for extensive aorto-iliac occlusive disease. The objective of this clinical investigation is to evaluate the safety and performance of the BeGraft Aortic covered stent Graft System \& the BeGraft Peripheral covered stent Graft System (Bentley Innomed, Hechingen, Germany) in CERAB configuration (Covered Endovascular Reconstruction of Aortic Bifurcation) for Aorto-iliac Occlusive Disease.

Conditions

• Aorto-iliac Occlusive Disease

Interventions

Type	Name	Description
DEVICE	endovascular intervention	Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) is a new, minimally invasive technique, for treating extensive and/or recurrent aorto-iliac occlusive disease. The technique rebuilds the diseased aortic bifurcation and iliac arteries through the use of stent-grafts introduced through the groin or arm arteries.

Timeline

• Start date: 2024-04-05
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2023-04-07
• Last updated: 2025-06-15

Locations

15 sites across 2 countries: Germany, Netherlands