BeGraft covered stents for rebuilding blocked aorto-iliac arteries with CERAB

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

This project will see if BeGraft aortic and peripheral covered stents used in a CERAB procedure can restore blood flow and reduce symptoms in adults with symptomatic aorto-iliac occlusive disease.

Quick facts

• Study type: Observational
• Enrollment: 109 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: FCRE (Foundation for Cardiovascular Research and Education) (Academic / other)
• Locations: 15 sites (Berlin and 14 other locations)
• Trial ID: NCT05805111 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomised, multi-center observational study enrolling adults with symptomatic aorto-iliac occlusive disease (Rutherford 2–5) who are anatomically eligible for Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) using the BeGraft Aortic and BeGraft Peripheral balloon-expandable covered stent graft systems. Devices are implanted in a CERAB configuration without chimney grafts, with angiographic criteria including lesion start at least 1 cm below the renal arteries and suitability for a 12 mm BeGraft Aortic. Up to three BeGraft Peripheral stents per iliac limb may be used, and overlapping segments require post-dilation when a 7 mm extension is used. Patients will be followed prospectively at scheduled visits to document device safety and performance across several German vascular centers.

Who should consider this trial

Good fit: Adults (≥18 years) with symptomatic peripheral artery disease (Rutherford 2–5), a life expectancy of at least 24 months, and anatomy suitable for CERAB using the BeGraft devices without chimney grafts are ideal candidates.

Not a fit: Patients whose lesions involve or require treatment of the renal arteries, who need chimney grafts, who have vessel anatomy unsuitable for a 12 mm BeGraft Aortic, or who have limited life expectancy are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the approach could restore arterial flow, relieve claudication or ischemic symptoms, and reduce the need for open surgical reconstruction in patients with extensive aorto-iliac occlusive disease.

How similar studies have performed: Covered balloon-expandable stents and CERAB reconstruction have shown promising results in prior cohort studies and registries, but prospective data specifically on the BeGraft systems in this configuration are limited.

Eligibility 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 exclusion criteria

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.

Where this trial is running

Berlin and 14 other locations

• Sankt Gertrauden-Krankenhaus — Berlin, Germany (Recruiting)
• Universitätsklinikum Frankfurt — Frankfurt, Germany (Recruiting)
• University Medical Center Goettingen — Göttingen, Germany (Recruiting)
• Universitätsklinikum Heidelberg — Heidelberg, Germany (Recruiting)
• Marienhospital Lünen — Lünen, Germany (Not_yet_recruiting)
• St. Franziskus-Hospital GmbH — Münster, Germany (Recruiting)
• Krankenhaus Barmherzige Brüder Regensburg — Regensburg, Germany (Recruiting)
• Uniklinikum Regensburg — Regensburg, Germany (Recruiting)
• Klinikum der Landeshauptstadt Stuttgart gKAöR — Stuttgart, Germany (Recruiting)
• Noordwest Ziekenhuisgroep Alkmaar — Alkmaar, Netherlands (Recruiting)
• Ziekenhuis Rijnstate Arnhem — Arnhem, Netherlands (Recruiting)
• Martini Ziekenhuis — Groningen, Netherlands (Recruiting)
• UMCG Groningen — Groningen, Netherlands (Recruiting)
• Maastricht UMC+ — Maastricht, Netherlands (Recruiting)
• HMC (Haaglanden Medisch Centrum) — The Hague, Netherlands (Recruiting)

Conditions Aorto-iliac Occlusive Disease