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.
The patient has been diagnosed with symptomatic peripheral artery disease, defined by Rutherford Becker Classification score 2 to 5.
Patient has a projected life-expectancy of at least 24 months.
Patient is ≥18 years old.
Patient is willing/capable and provides written consent to participate to the trial and confirmed to attend the expected follow-up visits.
Patient is currently participating in another interventional drug trial or device trial that has not completed the entire follow up period.
Patient has planned any surgical intervention/procedure, that is not related to the study procedure, within 30 days after the study procedure.
Patient had a Myocardial infarction or stroke within a period of 3 months prior to the study procedure.
Patient had surgery (e.g. bypass surgery or stenting) in target vessels previously.
Marc Bosiers, MD
Lead sponsor
FCRE (Foundation for Cardiovascular Research and Education)
Sponsor institution