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.
Patients with aorto-iliac occlusive disease, who have been diagnosed by means of Rutherford Becker Classification between 2 and 5.
Case-only
Prospective
endovascular intervention
DeviceCovered 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.
Freedom from clinically-driven target lesion revascularization
Freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as freedom from repeat endovascular revascularization to maintain or re-establish patency within the treated lesion.
Incidence of Serious Adverse Device Effects
Incidence of Serious Adverse Device Effects (SADE) and procedure related Serious Adverse Events (SAE) at 12 months follow up.
Technical success rate after procedure
Technical success rate after procedure defined as successful introduction and deployment of the study devices BeGraft Aortic covered stent Graft System \& the BeGraft Peripheral covered stent Graft System (Bentley Innomed, Hechingen, Germany) for CERAB procedures
Freedom for conversion to open surgical repair
Freedom for conversion to open surgical repair of the target lesion.
Patency rate of the target vessel
Patency rate of the target vessel (primary, primary assisted and secondary).
Time to re-vascularization/re-intervention
Time to re-vascularization/re-intervention
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Marc Bosiers, MD
Lead sponsor
FCRE (Foundation for Cardiovascular Research and Education)
Sponsor institution
