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

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

The objective of this prospective, multicenter, non-randomized, single-arm observational study is to evaluate the efficacy and the safety of the iCover covered stent for the treatment of de novo aorto-iliac atherosclerotic lesions in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease; Iliac Artery Disease; Angioplasty; Aorto-Iliac Atherosclerosis; Covered Stent
• Intervention / Treatment: Device: Covered stent implantation

• Study Type: Observational
• Enrollment (Anticipated): 214

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Onze Lieve Vrouw Aalst
    • Contact: Lieven Maene, MD
  • Bonheiden, Belgium
    • Imelda Bonheiden
    • Contact: Jürgen Verbist, MD
  • Dendermonde, Belgium
    • Az Sint Blasius Dendermonde
    • Contact: Koen Deloose, MD
  • Genk, Belgium
    • ZOL Genk
    • Contact: Wouter Lansink, MD
• France
  • Brest, France
    • Centre Hospitalier Universitaire de Brest
  • Paris, France
    • CHU Pitié Salpétrière
    • Contact: Laurent Chiche, MD
  • Paris, France
    • Hopital Paris Saint Joseph
    • Contact: Yann Gouëffic, MD
  • Pessac, France
    • Hôpital Privé Saint-Martin
    • Contact: Maximilien Giovannetti, MD
  • Strasbourg, France
    • Clinique Rhéna
    • Contact: Gilles Goyault, MD
  • Villeneuve-d'Ascq, France
    • Hôpital privé Villeneuve d'Ascq
    • Contact: Martin Rouer, MD
• Germany
  • Berlin, Germany, 10365
    • KEH Berlin
    • Contact: Jens Stegemann, MD
  • Rendsburg, Germany
    • Imland Klinik Rendsburg
    • Contact: Christian Wissgott, MD
  • Baden-Württemberg
    • Bad Krozingen, Baden-Württemberg, Germany, 79189
      • Herzzentrum Bad Krozingen
  • Rhineland-Palatinate
    • Kaiserslautern, Rhineland-Palatinate, Germany, 67657
      • MVZ Kaiserslautern
      • Contact: Dirk Mertens, MD
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Universitatsklinikum Leipzig
      • Contact: Andrej Schmidt, MD
• Spain
  • Barcelona, Spain
    • Hospital Universitari Germans Trias i Pujol
    • Contact: Marc Sirvent, MD
  • Barcelona, Spain
    • Hospital de Santa Creu I Sant Pau
    • Contact: Jaume Dilmé, MD
  • Bilbao, Spain
    • Hospital de Cruces
    • Contact: Juan Luis Fonseca, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Half of the patients will be classified as TASC II A or B lesions, the other half as TASC II C or D lesions.

Description

Inclusion criteria

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.

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 trial
15. Patient objection to participate in the trial

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iCover covered stent; Percutaneous transluminal angioplasty (PTA)	Device: Covered stent implantation; Percutaneous transluminal angioplasty (PTA) with iCover covered stent for the treatment of de novo aorto-iliac occlusive lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Target Lesion Primary Patency	Primary patency defined as the lack of restenosis and no need for reintervention of the target lesion at 12-month follow-up.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical safety of the iCover covered stent up to 1 month	Medical safety of the iCover covered stent will be evaluated by the occurrence of complications from day 0 to month 1: General complications: All cause death, Major adverse events (stroke, myocardial infarction, procedural-related serious adverse events and device failure or malfunction); Major local complications in the treated lesion or punctured site:Iliac arterial ruptureRetroperitoneal hematomaThrombosis of the iliac axis on the homolateral sideNeed for surgery to achieve hemostasisBleeding with loss of more than 2 g / dl of hemoglobinFalse aneurysm at the puncture siteHematoma at the puncture site requiring manual compression at 24 hours, or preventing resumption of walking at 24 hoursAppearance of ischemia on the ipsilateral side	From day 0 up to 1 month
Number of participants with major amputation at target limb	Amputations above the ankle of the target leg will be counted.	1, 6, 12, 24 months after index procedure
Primary sustained clinical improvement	Primary sustained clinical improvement defined as a sustained upward shift of 1 category of the Rutherford classification for patients with claudication, and by wound healing and rest pain resolution for patients in critical limb ischemia, without the need for repeated target lesion revascularization in surviving patients	1, 6, 12, 24 months after index procedure
Number of Participants With Target Lesion Primary Patency	Primary patency rate defined as the lack of restenosis and no need for reintervention of the target lesion.	6, 24 months after index procedure
Target lesion revascularization (TLR)	Target lesion revascularization (TLR) defined as the need for repeated procedures (endovascular or surgical) due to a problem arising from the lesion initially treated in surviving patients with preserved limbs	1, 6, 12, 24 months after index procedure
Target vessel revascularization (TVR)	Target vessel revascularization (TVR) defined as the need for repeated procedures (endovascular or surgical) due to a problem arising remote from the vessel initially treated in surviving patients with preserved limbs	1, 6, 12, 24 months after index procedure
Change in Walking Impairment Questionnaire from baseline	The Walking Impairment Questionnaire values will be recorded and compared to the baseline values. This questionnaire is a validated tool to assess walking capability in patients with Peripheral Arterial Disease in different situations.	1, 6, 12, 24 months after index procedure
Change in quality of life from baseline, as measured by EQ-5D	The EQ-5D Questionnaire values will be recorded and compared to the baseline values. It is a validated questionnaire to measure the quality of life based on 5 different parameters. Worst possible score in this study would be 0, best possible score would be 1. In addition, the patient indicates her/his current health on an analog scale from 0 (worst) to 100 (best).	1, 6, 12, 24 months after index procedure

Collaborators and Investigators

• Sponsor: iVascular S.L.U.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2022
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): May 30, 2025

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis
• Other Study ID Numbers: iliCo Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No