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
- Conditions
- Aorto-Iliacal Artheropathy
- Registration Number
- DRKS00028124
- Lead Sponsor
- IVascular
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 240
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary patency of the stent at 12 months.
- Secondary Outcome Measures
Name Time Method secondary endpoints: Secondary: For assessment:<br>- Technical success<br>- Procedural success<br>- Perioperative morbidity and mortality up to MI.<br>- Primary sustained clinical improvement in MI, MG, Ml2 and M24.<br>- Primary open rate on MG and M24.<br>- Secondary patency rate on MG, Ml2 and M24.<br>Target lesion revascularization: MG, Ml2 and M24.<br>Target limb revascularization: MG, Ml2, and M24.<br>Resting ankle-arm index at MI, MG, Ml2 and M24.