Aorto-iliac Occlusive Disease
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Marc Bosiers, MD
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion criteria 1. Patient has been identified with an chronic aorto-iliac occlusive lesion, with clinical necessity for treatment. 2. The patient has been diagnosed with symptomatic peripheral artery disease, defined by Rutherford Becker Classification score 2 to 5. 3. Patient has a projected life-expectancy of at least 24 months. 4. Patient is ≥18 years old. 5. Patient is willing/capable and provides written consent to participate to the trial and confirmed to attend the expected follow-up visits. Angiographic inclusion criteria: 1. Patient's anatomy is eligible for CERAB treatment, without the need for chimneys and can be treated with a Ø 12 mm BGA. 2. The aorto-iliac lesion begins at least 1 cm below the patent renal arteries without a need for treatment. 3. A maximum of 3 BeGraft Peripheral (Ø 7 or 8 mm) per limb in the iliac artery can be used. In case a Ø 7 mm is used to extend, the overlapping end must be post-dilated to ensure proper flow. 4. The target lesion has angiographic evidence of stenosis \>50% or occlusion. 5. Patient's common femoral artery and deep femoral artery are patent. General
Exclusion criteria
1. Patient is currently participating in another interventional drug trial or device trial that has not completed the entire follow up period. 2. Patient has planned any surgical intervention/procedure, that is not related to the study procedure, within 30 days after the study procedure. 3. Patient had a Myocardial infarction or stroke within a period of 3 months prior to the study procedure. 4. Patient had surgery (e.g. bypass surgery or stenting) in target vessels previously. 5. Patient has an acute severe systemic infection at time of screening or in period of 30 days prior to screening. 6. Patient has fresh thrombus at time of screening or in period of 14 days prior to screening. 7. Patient has a CERAB procedure that is staged. 8. Female patient with childbearing potential not taking adequate contraceptives. 9. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated. 10. Patients with known hypersensitivity to the stent material (L605) and/or PTFE. 11. Patients who are placed in an institution due to an institutional or court order. 12. An aneurysm in the abdominal aortic and iliac segments where CERAB will be placed is present. 13. Patient has or had aortic coarctation. 14. Patient had aortic injury/trauma related interventions previously. 15. Patient had suprarenal/visceral segment reconstructions previously. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from clinically-driven target lesion revascularization | at 12 months after procedure | 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 | at 12 months after procedure | Incidence of Serious Adverse Device Effects (SADE) and procedure related Serious Adverse Events (SAE) at 12 months follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patency rate of the target vessel | at 30 days post-procedure, 6-, 12-, and 24-months | Patency rate of the target vessel (primary, primary assisted and secondary). |
| Time to re-vascularization/re-intervention | at 30 days post-procedure, 6-, 12-, and 24-months | Time to re-vascularization/re-intervention |
| Patient reported outcomes | at 30 days post-procedure, 6-, 12-, and 24-months | Patient reported outcomes at 30 days post-procedure, 6-, 12-, and 24-months compared to pre-procedure |
| Technical success rate after procedure | at 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 |
| Hemodynamic improvement | at 30 days post-procedure, 6-, 12-, and 24-months | 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. |
| Safety endpoints | at 30 days post-procedure, 6-, 12-, and 24-months | 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 |
| Clinical success at every follow up visit | at 30 days post-procedure, 6-, 12-, and 24-months | 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 |
| Freedom for conversion to open surgical repair | at 30 days post-procedure, 6-, 12-, and 24-months | Freedom for conversion to open surgical repair of the target lesion. |
Countries
Germany, Netherlands
Outcome results
None listed