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

NCT05192616 | Active Not Recruiting

• 1 other identifier: iliCo Study
• Study Type: observational
• Target: 241
• Locations: 4 countries
• Sites: 18

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Primary Patency

  The primary patency, defined as the absence of restenosis in the target lesion over the 12-month follow-up period in patients who did not undergo a reintervention on the target lesion.

  12 months after index procedure.

Secondary Outcomes (14)

• Technical success rate

  Day 0.

• Procedural success rate

  Day 0.

• Freedom from All Major Adverse Event (MAEs)

  1, 6, 12, 24 months after index procedure.

• Incidence of Procedure- or Device- related Major Local Complications

  Up to 30 days after index procedure.

• Rates of Serious Adverse Events (SAEs)

  1, 6, 12, 24 months after index procedure.

Study Arms (1)

iCover covered stent

Percutaneous transluminal angioplasty (PTA)

Device: Covered stent implantation

Interventions

Covered stent implantation DEVICE

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

iCover covered stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5). Patients with de novo atheromatous aorto-iliac lesions. According to the incidence of TASC II lesions, approximately 70% of the patients will be classified as TASC II A or B lesions, while the other 30% will be classified as TASC II C or D lesions.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• iVascular S.L.U.: lead

Study Sites (18)

Onze Lieve Vrouw Aalst

Aalst, Belgium

Location

Imelda Bonheiden

Bonheiden, Belgium

Location

Az Sint Blasius Dendermonde

Dendermonde, Belgium

Location

ZOL Genk

Genk, Belgium

Location

Centre Hospitalier Universitaire de Brest

Brest, France

Location

CHU Pitié Salpêtrière

Paris, France

Location

Hôpital Paris Saint Joseph

Paris, France

Location

Hôpital privé Saint-Martin

Pessac, France

Location

Hôpital privé Villeneuve d'Ascq

Villeneuve-d'Ascq, France

Location

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

Location

MVZ Kaiserslautern

Kaiserslautern, Rhineland-Palatinate, 67657, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

KEH Berlin

Berlin, Germany

Location

Imland Klinik Rendsburg

Rendsburg, Germany

Location

Hospital de Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, Spain

Location

Hospital de Cruces

Bilbao, Spain

Location

Hospital Parc Taulí

Sabadell, Spain

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 14, 2022
• Study Start: April 27, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); FR (5); BE (4); ES (4)