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.
Study Type
OBSERVATIONAL
Enrollment
109
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.
Sankt Gertrauden-Krankenhaus
Berlin, Germany
RECRUITINGUniversitätsklinikum Frankfurt
Frankfurt, Germany
RECRUITINGUniversity Medical Center Goettingen
Göttingen, Germany
RECRUITINGUniversitätsklinikum Heidelberg
Heidelberg, Germany
RECRUITINGMarienhospital Lünen
Lünen, Germany
NOT_YET_RECRUITINGSt. Franziskus-Hospital GmbH
Münster, Germany
RECRUITINGKrankenhaus Barmherzige Brüder Regensburg
Regensburg, Germany
RECRUITINGUniklinikum Regensburg
Regensburg, Germany
RECRUITINGKlinikum der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Germany
RECRUITINGNoordwest Ziekenhuisgroep Alkmaar
Alkmaar, Netherlands
RECRUITING...and 5 more locations
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.
Time frame: at 12 months after procedure
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.
Time frame: at 12 months after procedure
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
Time frame: at procedure
Freedom for conversion to open surgical repair
Freedom for conversion to open surgical repair of the target lesion.
Time frame: at 30 days post-procedure, 6-, 12-, and 24-months
Patency rate of the target vessel
Patency rate of the target vessel (primary, primary assisted and secondary).
Time frame: at 30 days post-procedure, 6-, 12-, and 24-months
Time to re-vascularization/re-intervention
Time to re-vascularization/re-intervention
Time frame: at 30 days post-procedure, 6-, 12-, and 24-months
Patient reported outcomes
Patient reported outcomes at 30 days post-procedure, 6-, 12-, and 24-months compared to pre-procedure
Time frame: at 30 days post-procedure, 6-, 12-, and 24-months
Clinical success at every follow up visit
Clinical success at every follow up visit, defined as an improvement of Rutherford classification of one class or more compared to the pre-procedure Rutherford classification
Time frame: at 30 days post-procedure, 6-, 12-, and 24-months
Hemodynamic improvement
Hemodynamic improvement defined as increase in Ankle Brachial Index (ABI) of at least 0.10 compared to baseline ABI (pre-procedure) at 30 days post-procedure, 6-, 12-, and 24-months.
Time frame: at 30 days post-procedure, 6-, 12-, and 24-months
Safety endpoints
1. Incidence of Serious Adverse Device Effects (SADE) and procedure related Serious Adverse Events (SAE) 2. 30-day mortality. 3. Overall survival rate 4. Incidence of Major Adverse Events
Time frame: at 30 days post-procedure, 6-, 12-, and 24-months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.