EverFlex Post Approval Study

Study Overview
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Brief Summary
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This post-approval study is designed to confirm the long-term safety and effectiveness of the EverFlex™ Self-Expanding Stent System for the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal arteries.

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 EverfLex NitInol STent System Post Approval Study

Conditions
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Peripheral Arterial Disease, Lower Extremity Arterial Disease

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


Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria Has 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 suitable for primary stenting. Has a Rutherford Clinical Category Score of 2, 3 or 4. Is willing to comply with all follow-up evaluations at the specified times. Is ≥ to18 years old. Provides written informed consent prior to enrollment in the study. Angiographic Inclusion Criteria Subjects must meet all of the following angiographic inclusion criteria. The implanting physician bases all angiographic inclusion criteria on visual determination at the time of the procedure. Target lesion(s) located within the native SFA/proximal popliteal: distal point at least 3 cm above the cortical margin of the femur and proximal point at least 1 cm below the origin of the profunda femoralis measured by straight posteroanterior (PA) view for distal lesions, ipsilateral oblique view for proximal lesions. Evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s). Target lesion(s) total length is ≥ 4 cm and ≤ 18 cm. Target vessel diameter is ≥ 4.5 mm and ≤ 7.5 mm. There is evidence of at least one runoff vessel to the ankle/foot of the limb to be treated that does not also require treatment for significant (> 50% stenosis or occlusion) stenosis during the index procedure. General Exclusion Criteria Has undergone previous implantation of stent(s) or stent graft(s) in the target vessel. Has a contraindication or known allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, contrast media or any other drug used in study according to the protocol. Has known hypersensitivity to nickel-titanium. Has bleeding diathesis, coagulopathy, known hypercoagulable condition, or refuses blood transfusion. Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures. Has life expectancy of less than 1 year. Has planned use of thrombectomy, atherectomy, brachytherapy or laser devices during procedure. Has previously been enrolled in the DURABILITY PAS study. Has received endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure. Has any planned surgical intervention or endovascular procedure 14 days before or 30 days after the index procedure. Is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. Has any co-morbid condition that precludes endovascular treatment. Angiographic Exclusion Criteria The subject must not meet any of the following angiographic exclusion criteria. The implanting physician bases all angiographic exclusion criteria on visual determination at the time of the procedure. Exchangeable guidewire cannot cross the target lesion and/or re-enter true vessel lumen distal to lesion(s). Presence of significant (> 50% stenosis or occlusion) ipsilateral common femoral stenosis. Aneurysmal target vessel. Presence of an acute intraluminal thrombus at the proposed lesion site. Perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to start of PTA procedure. Focal popliteal disease in the absence of femoral disease.

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: Study cohort<br>All patients enrolled in this study will be treated with the EverFlex™ Self-Expanding Peripheral Stent System. | Device: EverFlex™ Self-Expanding Peripheral Stent System<br>* Using the EverFlex™ Self-Expanding Peripheral Stent System to treat atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions 4-18 cm long in subjects with Rutherford Clinical Categories 2-4.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization | Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal. | 3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome - Freedom From Stent Fracture | Determined by x-ray at 1, 2 and 3 years using the following classifications: Class 0 - No strut fractures Class I - Single tine fracture Class II - Multiple tine fractures Class III - Stent fracture(s) with preserved alignment of the components Class IV - Stent fracture(s) with mal-alignment of the components Class V - Stent fracture(s) in a trans-axial spiral configuration AND the following categories: Category A - Restenosis ≤ 50% at site of fracture Category B - Restenosis ≥ 50% at site of fracture Category C - Occlusion at site of fracture Category D - Unable to determine | 1, 2 and 3 years | 
| Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years | Defined as the absence of all-cause mortality occurring within 30-days, absence of any major amputation within 12-/24- months and the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 12-/24- months of the procedure. | 1 and 2 years | 
| Secondary Outcome - Freedom From 36-month Amputation | Defined as the absence of any major amputation (removal of the target limb or a part of the target limb above the metatarsal line) within 36 months of the procedure. | 3 Years | 
| Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization | Defined as the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 36 months of the procedure. | 3 Years | 
| Secondary Outcome - Number of Participants Free From Acute Death | Defined as the absence of all-cause mortality occurring within 30 days of the procedure. | 30 days | 
| Secondary Outcome - Number of Successfully Implanted Stents | Defined as the ability to deploy the stent as intended at the treatment site. | At procedure | 
| Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year | Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline. | 1 Year | 
| Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year | Defined as an increase in the ankle-brachial index (ABI) compared to baseline in subjects with compressible arteries and baseline ABI < 0.9. | 1 Year | 
| Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year | Defined as an increase in Walking Impairment Questionnaire score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline Scale Range: Minimum score 0 to maximum score 100 Higher values represent better outcomes | 1 Year | 
| Secondary Outcome - Number of Adverse Events | Number of Adverse Events in the study through 3 Years. | 3 Years |