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

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

The objective of this prospective, multi-center, non-randomized, single-arm observational study is to evaluate the safety and the efficacy of the iCover covered stent over a 24-month follow-up period for the treatment of de novo iliac occlusive lesions, defined by a significant vessel stenosis ≥70%, in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).

This is a prospective, single-arm, multinational, and multicenter study conducted to evaluate the safety and efficacy of the iCover covered stent for the treatment of de novo iliac occlusive lesions (common and/or external iliac arteries) in patients with symptomatic lower limb arteriopathy. The primary endpoint of the study is primary patency, defined as the absence of restenosis in the target lesion over a 12-month follow-up period in patients who did not undergo a reintervention on the target lesion. Restenosis is defined as a reduction in the luminal diameter of more than 50%, assessed either by duplex ultrasound (considered as a peak systolic velocity index ≥ 2.4 at the target lesion) or by angio-CT (multiplanar reconstruction). Secondary endpoints include: technical and procedural success rate, freedom from all major adverse events, incidence of procedure- or device-related major local complications at the treated lesion, rate of SAEs, major amputation rate at the target limb, primary sustained clinical improvement (improvement in Rutherford classification), primary and secondary patency rates, TLR and TVR rates, and changes in ABI, the Walking Impairment Questionnaire, and the EQ-5D questionnaire from baseline.

Inclusion criteria

1. ≥ 18 years of age
2. Rutherford clinical stage 2 to 5
3. Significant (≥70%) stenosis of atheromatous iliac lesions evidenced by duplex scan, MRI 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 Exclusion criteria

Subjects will not be eligible to participate in the study if any of the following conditions are present in the subject:

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 investigation
15. Patient objection to participate in the investigation