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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovascular intervention | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | at 12 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at procedure |
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General Inclusion criteria
Angiographic inclusion criteria:
General Exclusion criteria:
Angiographic exclusion criteria
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Patients with aorto-iliac occlusive disease, who have been diagnosed by means of Rutherford Becker Classification between 2 and 5.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sankt Gertrauden-Krankenhaus | Recruiting | Berlin | Germany |
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| Freedom for conversion to open surgical repair |
Freedom for conversion to open surgical repair of the target lesion. |
| 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). | at 30 days post-procedure, 6-, 12-, and 24-months |
| Time to re-vascularization/re-intervention | Time to re-vascularization/re-intervention | 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 | 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 | 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. | at 30 days post-procedure, 6-, 12-, and 24-months |
| Safety endpoints |
| at 30 days post-procedure, 6-, 12-, and 24-months |
| Universitätsklinikum Frankfurt | Recruiting | Frankfurt | Germany |
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| University Medical Center Goettingen | Recruiting | Göttingen | Germany |
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| Universitätsklinikum Heidelberg | Recruiting | Heidelberg | Germany |
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| Marienhospital Lünen | Not yet recruiting | Lünen | Germany |
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| St. Franziskus-Hospital GmbH | Recruiting | Münster | Germany |
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| Krankenhaus Barmherzige Brüder Regensburg | Recruiting | Regensburg | Germany |
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| Uniklinikum Regensburg | Recruiting | Regensburg | Germany |
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| Klinikum der Landeshauptstadt Stuttgart gKAöR | Recruiting | Stuttgart | Germany |
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| Noordwest Ziekenhuisgroep Alkmaar | Recruiting | Alkmaar | Netherlands |
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| Ziekenhuis Rijnstate Arnhem | Recruiting | Arnhem | Netherlands |
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| Martini Ziekenhuis | Recruiting | Groningen | Netherlands |
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| UMCG Groningen | Recruiting | Groningen | Netherlands |
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| Maastricht UMC+ | Recruiting | Maastricht | Netherlands |
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| HMC (Haaglanden Medisch Centrum) | Recruiting | The Hague | Netherlands |
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