Prospective, multicenter, non-randomized, single-arm observational study to evaluate safety and effectiveness of iCover covered stent for the treatment of the aorto-iliac Occlusive Disease - ILICO

IVascular0 个研究点目标入组 240 人开始时间: 2022年2月15日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. = 18 years of age
•2. Rutherford clinical stage 2 to 5
•3. Atheromatous aorto-iliac lesions evidenced by duplex scan, CT angiography or arteriography.
•4. De novo atheromatous lesion of the aortoiliac segment
•5. Patient informed about the study and collection of the patient's informed consent agreement.

•1. Protected adult patients, guardianship, curatorship, safeguard of justice
•2. Woman with possibility of pregnancy
•3. Patient with asymptomatic atheromatous lesions
•4. Patient with inflow lesion in the infrarenal aorta
•5. Patient treated with Covered endovascular reconstruction of aortic bifurcation (CERAB reconstruction)
•6. Acute ischemia or acute thrombosis
•7. Non-atherosclerotic disease
•8. History of coagulopathy
•9. Severe comorbidities with life expectancy <2 years
•10. 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
•11. Patient participating in another clinical study which may interfere with the results
•12. 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
•13. Lesion near or adjacent to an aneurysm
•14. Inability to follow-up during the trial
•15. Patient objection to participate in the trial

发起方