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) - CERAB

FCRE - Foundation for Cardiovascular Research and Education0 sites60 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

FCRE - Foundation for Cardiovascular Research and Education

•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

•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