RecruitingNCT05805111

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


Sponsor

Marc Bosiers, MD

Enrollment

109 participants

Start Date

Apr 5, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called endovascular intervention for people with aorto iliac occlusive disease. The study is currently recruiting participants at 15 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEendovascular 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

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NCT05805111


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