A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease

Study Overview
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Brief Summary
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The purpose of this study (superiority trial) is to compare the Supera® Peripheral Stent System with a standard nitinol self-expanding stent for treatment of femoro-popliteal arterial occlusive disease. Hypothesis: The Supera® stent is superior to a standard nitinol self-expanding stent, for treatment of femoro-popliteal artery disease in terms of (1) primary patency rate and (2) need for revascularization up to 24 months after stent insertion.

Official Title
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A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Supera® Peripheral Stent System
* Device: EverFlex™ Self-Expanding Peripheral Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with femoro-popliteal artery disease, who will require a stent femoro-popliteal following failed percutaneous transluminal angioplasty (PTA) Target Lesion length <200mm Planned follow-up available for at least 24 months Written informed consent to participate in the study and agreement to comply with the study protocol must be obtained from the patient prior to initiation of any study-mandated procedure and randomization Exclusion Criteria: Life expectancy <24 months Patients who cannot receive dual antiplatelet therapy (aspirin 100mg and clopidogrel 75mg) or anticoagulation therapy Patients with known allergies to: nitinol (nickel titanium); or contrast agent, that cannot be medically managed Participation in another study with investigational drug/device within the 30 days preceding and during the present study Previous enrolment into the current study Prior stenting at the location of intended stenting Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system Enrolment of study investigator, his/her family members, employees and other dependent persons If female and of childbearing potential: known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supera® Peripheral Stent System<br>Femoro-popliteal arterial stenting with Supera® Peripheral Stent System as CE-marked by the manufacturer Abbott | Device: Supera® Peripheral Stent System<br>* The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.<br>|
| Active Comparator: EverFlex™ Self-Expanding Peripheral Stent System<br>Femoro-popliteal arterial stenting with EverFlex™ Self-Expanding Peripheral Stent System with Entrust™ Delivery System or as Protégé™ EverFlex™ | Device: EverFlex™ Self-Expanding Peripheral Stent System<br>* The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.<br>* Other names: EverFlex™ with Entrust™ Delivery System or Protégé™ EverFlex™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in primary patency rate (proportion of patients classed as treatment succsess) | Peak systolic velocity ratio assessed with Duplex ultrasound (Treatment success is defined as Peak Systolic Velocity (PSV) ratio < 2.5 at the stented target lesion measured by Duplex ultrasound (DUS) indicating freedom from >50% restenosis with no clinically driven re-intervention within the stented segment.) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in primary patency rate | Peak systolic velocity ratio assessed with Duplex ultrasound | 1 month, 6 months, 12 months | 
| Difference in target lesion/vessel revascularization | Patients with target lesion revascularization due to restenosis or target vessel revascularization. | 24 months | 
| Difference in amputation | Proportion of patients with amputation (minor or major) | 24 months | 
| Difference in time to restenosis (and time to target lesion revascularization due to restenosis) |  | 24 months | 
| Difference in Anklre Brachial Index | Ankle Brachial Index of the treated lesion | 1 month, 6 months, 12 months, 24 months | 
| Difference in Fontaine classification | Fontaine classification | 1 month, 6 months, 12 months, 24 months |