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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Aorto-iliac Occlusive Disease

Intervention / Treatment
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* Device: endovascular intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has been identified with an aorto-iliac occlusive lesion, with clinical necessity for treatment. 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 and capable to provide written consent to participate to the trial and confirmed to attend the expected follow-up visits. Patient's anatomy is eligible for CERAB treatment, without the need for chimneys and can be treated with a Ø 12 mm BGA. The aorto-iliac lesion begins at least 1 cm below the patent renal arteries without a need for treatment. A maximum of 3 BeGraft Peripheral (Ø 7 or 8 mm) per limb in the external iliac artery can be used. In case a Ø 7 mm is used to extent, the distal ends must be flared to Ø 8 mm to ensure proper flow. The target lesion has angiographic evidence of stenosis >50% or occlusion of the limb. Patient's common femoral artery and deep femoral artery are patent. Exclusion Criteria: Patient is currently participating in another investigational drug or device trial that has not completed the entire follow up period. Patient has planned any surgical intervention/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. Patient with acute aortic or iliac occlusive disease. Patient has an acute systemic infection at time of screening or in period of 30 days prior to screening. Patient has fresh thrombus at time of screening or in period of 14 days prior to screening. Patient has a CERAB procedure that is staged. Female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated. Patients with known hypersensitivity to the stent material (L605) and/or PTFE. An aneurysm in the abdominal aortic and iliac segments where CERAB will be placed is present. Patient has access vessel that is too tortuous, narrow or any other reason that would lead to failure of introducing and advancing an introducer sheath. Patient has or had aortic coarctation. Patient had aortic injury/trauma related interventions previously. Patient had suprarenal/visceral segment reconstructions previously. A relevant accessory renal artery (>3 mm) in the infrarenal aorta is present, that might be occluded during the procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | Incidence of Serious Adverse Device Effects (SADE) and procedure related Serious Adverse Events (SAE) 30-day mortality. Overall survival rate Incidence of Major Adverse Events | at 30 days post-procedure, 6-, 12-, and 24-months |