a Physician-inititated Trial Investigating the iVolution Nitinol Stent

Study Overview
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Brief Summary
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The objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.

Official Title
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EVOLUTION STUDY, a Physician-inititated Trial Investigating the Efficacy of the Self-Expanding iVolution Nitinol Stent for Treatment of Femoropopliteal Lesions

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: iVolution nitinol stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: De novo lesion located in the femoropopliteal arteries suitable for endovascular treatment Patient presenting with a score from 2 to 4 according to the Rutherford classification Patient is willing and able to comply with specified follow-up evaluations at the predefined time intervals Patient is >18 years old Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study Prior to enrollment, the target lesion was crossed with standard guidewire manipulation One target lesion is located within the native SFA: distal point 3 cm above knee joint The target lesion has angiographic evidence of stenosis or occlusion Length of the target lesion is ≤ 15 cm by visual estimation Target vessel diameter visually estimated is ≥4 mm and ≤7 mm There is angiographic evidence of at least one vessel-runoff to the foot Exclusion Criteria: Presence of a stent in the target vessel that was placed during a previous procedure Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis Previous bypass surgery in the same limb Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics Patients who exhibit persistent acute intraluminal thrombus at the target lesion site Perforation at the angioplasty site evidenced by extravasation of contrast medium Patients with known hypersensitivity to nickel-titanium or other study device components Patients with uncorrected bleeding disorders Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding Life expectancy of less than 12 months Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30% Use of thrombectomy, atherectomy or laser devices during procedure Any patient considered to be hemodynamically unstable at onset of procedure Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iVolution stent<br>Patient's treated with the iVolution stent from iVascular for the treatment of femoropopliteal lesions. | Device: iVolution nitinol stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency at 12 months | freedom from >50% restenosis at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success |  | Procedure | 
| Primary Patency at 1 & 6 months |  | 1 & 6 months | 
| Freedom from Target Lesion Revascularization (TLR) at 1, 6 and 12 months |  | at all follow-up visits | 
| Clinical Success at 1, 6 and 12 months | Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-, 6- & 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification. | at all follow-up visits | 
| Serious adverse events until follow-up completions | Any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | 1,6,12 months and interem visits |