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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sankt Gertrauden-Krankenhaus
  Berlin, Germany Recruiting
• Universitätsklinikum Frankfurt
  Frankfurt, Germany Recruiting
• University Medical Center Goettingen
  Göttingen, Germany Recruiting
• Universitätsklinikum Heidelberg
  Heidelberg, Germany Recruiting
• St. Franziskus-Hospital GmbH
  Münster, Germany Recruiting
• Krankenhaus Barmherzige Brüder Regensburg
  Regensburg, Germany Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.