Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis

Study Overview
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Brief Summary
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This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.

Official Title
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The US StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II

Conditions
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Peripheral Vascular Diseases, Claudication

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries. Symptomatic femoral-popliteal atherosclerosis. Willing to comply with all follow-up evaluations at the specified times. Provides written informed consent prior to enrollment in the study. Exclusion Criteria: Previously implanted stent(s) or stent graft(s) in the target vessel. Planned use of devices other than angioplasty balloons during procedure. Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure. Life expectancy of less than 12 months. Symptomatic femoral disease in the opposite limb.

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: PTA and Stenting with EverFlex device<br>Qualified subjects undergo treatment of atherosclerotic lesions in the native SFA/SFA/PPA with PTA and stenting using the PROTÉGÉ® EverFlex™ Self-Expanding Stent System | Device: PROTÉGÉ® EverFlex™ Self-Expanding Stent System<br>* Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency | Primary stent patency, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. | 1 Year | 
| Major Adverse Events | Major Adverse Events (MAE) was defined as clinically-driven Target Lesion Revascularization (TLR), amputation of treated limb, or all-cause mortality, as adjudicated by the Clinical Events Commettee (CEC) | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single-Stent Primary Patency | Primary stent patency in subjects with single-stent, as determined by the core laboratory, was defined as PSV ratio < 2.0 at the stented target lesion as measured by duplex ultrasound at the 1-year follow-up visit (335-395 days post procedure) and no clinically-driven TLR within the stented segment within 1 year of the procedure. Single stents were implanted in 272 subject. | 1 Year | 
| Single-Stent Major Adverse Events | MAE rate in subjects who received a single stent was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurred within 30-days post-procedure, as adjudicated by the CEC. Single stents were implanted in 272 subjects. | 30 Days | 
| Major Adverse Events | MAE rate at 1 year was defined as clinically-driven TLR, amputation of treated limb, or all-cause mortality that occurs within 1 year post-procedure, as adjudicated by the CEC. | 1 Year | 
| Stent Fracture Rate | Stent integrity determined by x-ray at 1, 2 and 3 years post stent implantation. | 1, 2 and 3 Years | 
| Number of Participants With Decline in Rutherford Clinical Category | Defined as an increase of one or more categories in Rutherford Clinical classification compared to baseline. The symptomatic classification is a scale of 0-6, asymptomatic to major tissue loss. | 30 days | 
| Improvement in Rutherford Clinical Category | Improvement in Rutherford Clinical Category (RCC) was defined as an improvement in clinical status indicated by a decrease of one or more categories in RCC compared to baseline. | 1 year | 
| Increase in Ankle-Brachial Index From Baseline to 1 Year | Defined as an increase in ancle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9. | 1 Year | 
| Assisted Primary Patency | Assisted primary patency at 1 year was defined as PSV ratio < 2.0 as measured by binary duplex ultrasound maintained by repeated percutaneous intervention completed prior to complete vessel closure. Kaplan-Meier assisted primary patency was evaluated in all enrolled subjects. | 1 Year | 
| Secondary Patency | Secondary patency was defined as PSV ratio < 2.0 maintained by repeat percutaneous intervention after occlusion of the target lesion. Secondary patency was evaluated by the Kaplan-Meier method in all enrolled subjects. | 1 Year | 
| Absolute Claudication Distance Improvement | Absolute claudication distance improvement at 1 year was defined as the increase in walking distance determined by a graded treadmill exercise test. Only assessed in subjects enrolled under study procol versions in which the endpoint was predefined. | 1 Year | 
| Walking Improvement | Walking improvement was defined as an increase in Walking Impairment Questionnaire (WIQ) score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline. | 1 Year | 
| Duplex Ultrasound ≤ 2.4 Primary Patency | Defined as a binary duplex ultrasound ratio ≤ 2.4 at the stented target lesion with no clinically-driven reintervention without the stented segment. Duplex Ultrasound ≤ 2.4 primary patency was evaluated by the Kaplan-Meier method in all enrolled subjects. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SFA, Popliteal, Stent, EverFlex