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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Angioplasty, Peripheral Arterial Disease, Iliac Artery Disease, Covered Stent, Aorto-Iliac Atherosclerosis

Intervention / Treatment
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* Device: Covered stent implantation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria ≥ 18 years of age Rutherford clinical stage 2 to 5 Atheromatous aorto-iliac lesions evidenced by duplex scan, 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 trial Patient objection to participate in the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| iCover covered stent<br>Percutaneous transluminal angioplasty (PTA) | Device: Covered stent implantation<br>* Percutaneous transluminal angioplasty (PTA) with iCover covered stent for the treatment of de novo aorto-iliac occlusive lesions<br>|

What is the study measuring?
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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 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 | 
| 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 |