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

NCT ID: NCT05192616

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 241 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2026-06-30

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 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).

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 (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.

Conditions

Angioplasty; Peripheral Arterial Disease; Iliac Artery Disease; Covered Stent; Aorto-Iliac Atherosclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

iCover covered stent

Percutaneous transluminal angioplasty (PTA)

Covered stent implantation

Intervention Type: DEVICE

Percutaneous transluminal angioplasty (PTA) with iCover covered stent for the treatment of de novo aorto-iliac occlusive lesions

Interventions

Covered stent implantation

Percutaneous transluminal angioplasty (PTA) with iCover covered stent for the treatment of de novo aorto-iliac occlusive lesions

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

iVascular S.L.U.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Onze Lieve Vrouw Aalst

Aalst, , Belgium

Imelda Bonheiden

Bonheiden, , Belgium

Az Sint Blasius Dendermonde

Dendermonde, , Belgium

ZOL Genk

Genk, , Belgium

Centre Hospitalier Universitaire de Brest

Brest, , France

CHU Pitié Salpêtrière

Paris, , France

Hôpital Paris Saint Joseph

Paris, , France

Hôpital privé Saint-Martin

Pessac, , France

Hôpital privé Villeneuve d'Ascq

Villeneuve-d'Ascq, , France

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, Germany

MVZ Kaiserslautern

Kaiserslautern, Rhineland-Palatinate, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

KEH Berlin

Berlin, , Germany

Imland Klinik Rendsburg

Rendsburg, , Germany

Hospital de Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitari Germans Trias i Pujol

Barcelona, , Spain

Hospital de Cruces

Bilbao, , Spain

Hospital Parc Taulí

Sabadell, , Spain

Countries

Belgium; France; Germany; Spain

Other Identifiers

iliCo Study

Identifier Type: -

Identifier Source: org_study_id