CompletedNo phase
Safety and Effectiveness Evaluation of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease
Key facts
- Who runs it
- iVascular S.L.U.
- Where
- Belgium, France, Germany, and Spain18 sites in 4 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 241 people enrolled
- Started
- 27 Apr 2022
- Ended
- 30 Sept 2026
- Type of study
- Observational
- Treatments tested
- Covered stent implantation
- Record updated
- 5 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- ≥ 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
This trial has no sites in United States.
It has sites in 4 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
The group in the trial
- iCover covered stent
Percutaneous transluminal angioplasty (PTA)
Treatment: Covered stent implantation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 5 November 2026