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RECRUITING
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

Sponsor: Marc Bosiers, MD

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

109

Start Date

2024-04-05

Completion Date

2027-07

Last Updated

2025-06-15

Healthy Volunteers

No

Interventions

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.

Locations (15)

Sankt Gertrauden-Krankenhaus

Berlin, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

University Medical Center Goettingen

Göttingen, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Marienhospital Lünen

Lünen, Germany

St. Franziskus-Hospital GmbH

Münster, Germany

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, Germany

Uniklinikum Regensburg

Regensburg, Germany

Klinikum der Landeshauptstadt Stuttgart gKAöR

Stuttgart, Germany

Noordwest Ziekenhuisgroep Alkmaar

Alkmaar, Netherlands

Ziekenhuis Rijnstate Arnhem

Arnhem, Netherlands

Martini Ziekenhuis

Groningen, Netherlands

UMCG Groningen

Groningen, Netherlands

Maastricht UMC+

Maastricht, Netherlands

HMC (Haaglanden Medisch Centrum)

The Hague, Netherlands