Status:
ACTIVE_NOT_RECRUITING
Safety and Effectiveness Evaluation of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease
Lead Sponsor:
iVascular S.L.U.
Conditions:
Angioplasty
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
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 (...
Eligibility Criteria
Inclusion
- Inclusion criteria
- ≥ 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
Exclusion
Key Trial Info
Start Date :
April 27 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT05192616
Start Date
April 27 2022
End Date
June 1 2026
Last Update
May 16 2025
Active Locations (18)
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1
Onze Lieve Vrouw Aalst
Aalst, Belgium
2
Imelda Bonheiden
Bonheiden, Belgium
3
Az Sint Blasius Dendermonde
Dendermonde, Belgium
4
ZOL Genk
Genk, Belgium