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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-05

Study Completion Date

2027-07-31

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.

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Detailed Description

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Conditions

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Aorto-iliac Occlusive Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

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.

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.

1. Failure of recanalization
2. A relevant accessory renal artery (\>3 mm) in the infrarenal aorta is present, that might be occluded during the procedure.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No