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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
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
Conditions
Interventions
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