Safety and Effectiveness Evaluation of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease

Ki vehet részt

• ≥ 18 years of age
• Rutherford clinical stage 2 to 5
• Significant (≥70%) stenosis of atheromatous iliac lesions evidenced by duplex scan, MRI CT angiography or arteriography
• De novo atheromatous lesion of the aortoiliac segment
• Patient informed about the study and collection of the patient's informed consent agreement Exclusion criteria; Subjects will not be eligible to participate in the study if any of the following conditions are present in the subject:
• Protected adult patients, guardianship, curatorship, safeguard of justice
• Woman with possibility of pregnancy
• Patient with asymptomatic atheromatous lesions
• Patient with inflow lesion in the infrarenal aorta
• Patient treated with Covered endovascular reconstruction of aortic bifurcation (CERAB reconstruction)
• Acute ischemia or acute thrombosis
• Non-atherosclerotic disease
• History of coagulopathy
• Severe comorbidities with life expectancy <2 years
• Contraindication to taking antiplatelet aggregation therapy (aspirin or clopidogrel). The patient must be able to take an antiplatelet aggregation for at least 3 months after the procedure
• Patient participating in another clinical study which may interfere with the results
• Comorbidity or any reason which, according to the investigator, could limit the participation, the patient's adherence with the follow-up or the scientific integrity of the study
• Lesion near or adjacent to an aneurysm
• Inability to follow-up during the investigation
• Patient objection to participate in the investigation