Prospective, Non-Randomised Clinical Trial to investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System treating Aorto-iliac Occlusive Disease with CERAB (Covered Endovascular Reconstruction of Aortic Bifurcation)

• Conditions: 10003216; aorto-iliac occlusive disease; blockage of iliac and aortic arteries

• Registration Number: NL-OMON56642
• Lead Sponsor: FCRE - Foundation for Cardiovascular Research and Education

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Patient has been identified with an 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 and capable
to provide written consent to participate to the trial and confirmed to attend
the expected follow-up visits. 6. Patient*s anatomy is eligible for CERAB
treatment, without the need for chimneys and can be treated with a Ø 12 mm BGA.
7. The aorto-iliac lesion begins at least 1 cm below the patent renal arteries
without a need for treatment. 8. 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. 9.
The target lesion has angiographic evidence of stenosis >50% or occlusion of
the limb. 10. Patient*s common femoral artery and deep femoral artery are
patent.

Exclusion Criteria

1. Patient is currently participating in another investigational drug or device
trial that has not completed the entire follow up period. 2. Patient has
planned any surgical intervention/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 with acute aortic
or iliac occlusive disease. 6. Patient has an acute systemic infection at time
of screening or in period of 30 days prior to screening. 7. Patient has fresh
thrombus at time of screening or in period of 14 days prior to screening. 8.
Patient has a CERAB procedure that is staged. 9. Female patient with
childbearing potential not taking adequate contraceptives or currently
breastfeeding 10. Patients for whom antiplatelet therapy, anticoagulants or
thrombolytic drugs are contraindicated 11. Patients with known hypersensitivity
to the stent material (L605) and/or PTFE 12. An aneurysm in the abdominal
aortic and iliac segments where CERAB will be placed is present. 13. 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. 14. Patient
has or had aortic coarctation. 15. Patient had aortic injury/trauma related
interventions previously. 16. Patient had suprarenal/visceral segment
reconstructions previously. 17. A relevant accessory renal artery (>3 mm) in
the infrarenal aorta is present, that might be occluded during the procedure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified