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

Peripheral Arterial Disease Clinical Trial

— ILICO  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05192616
• Other study ID #: iliCo Study
• Status: Not yet recruiting
• Start date: February 15, 2022
• Est. completion date: May 30, 2025

Study information

• Verified date: December 2021
• Source: iVascular S.L.U.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 214
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angioplasty
• Aorto-Iliac Atherosclerosis
• Atherosclerosis
• Iliac Artery Disease
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Aalst	Aalst
Belgium	Imelda Bonheiden	Bonheiden
Belgium	Az Sint Blasius Dendermonde	Dendermonde
Belgium	ZOL Genk	Genk
France	Centre Hospitalier Universitaire de Brest	Brest
France	CHU Pitié Salpêtrière	Paris
France	Hôpital Paris Saint Joseph	Paris
France	Hôpital privé Saint-Martin	Pessac
France	Clinique Rhena	Strasbourg
France	Hôpital privé Villeneuve d'Ascq	Villeneuve-d'Ascq
Germany	Herzzentrum Bad Krozingen	Bad Krozingen	Baden-Württemberg
Germany	KEH Berlin	Berlin
Germany	MVZ Kaiserslautern	Kaiserslautern	Rhineland-Palatinate
Germany	Universitätsklinikum Leipzig	Leipzig	Saxony
Germany	Imland Klinik Rendsburg	Rendsburg
Spain	Hospital de Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Germans Trias i Pujol	Barcelona
Spain	Hospital de Cruces	Bilbao

Sponsors (1)

Lead Sponsor	Collaborator
iVascular S.L.U.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 rupture; Retroperitoneal hematoma; Thrombosis of the iliac axis on the homolateral side; Need for surgery to achieve hemostasis; Bleeding with loss of more than 2 g / dl of hemoglobin; False aneurysm at the puncture site; Hematoma at the puncture site requiring manual compression at 24 hours, or preventing resumption of walking at 24 hours; Appearance of ischemia on the ipsilateral side	From day 0 up to 1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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