Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System

Study Overview
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Brief Summary
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This is a clinical study of a new self-expanding stent (FlexStent®) designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The arteries are often abbreviated as femoropopliteal. The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, the FlexStent® shall meet or exceed the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.

Official Title
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Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System Study

Conditions
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Vascular Disease, PAD, Cardiovascular Diseases, Peripheral Artery Disease, Peripheral Vascular Disease

Intervention / Treatment
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* Device: FlexStent® Femoropopliteal Self Expanding Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must meet the following criteria: Subjects, male or female, must be at least 35 years of age at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test within 7 days of screening. Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol. Rutherford Classification Category 2-4 De novo lesion in the Femoropopliteal artery, including the entire extent of the superficial femoral artery and the proximal portion of the popliteal artery extending to the medial condyle 3 cm above the knee joint Disease segment length ≤ 180 mm >70% diameter stenosis and/or occlusion based on site-determined visual angiography Patent ipsilateral iliac artery Patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with no planned intervention Target reference vessel diameter 3.5-7.5 mm. Projected life expectancy of 12 months or greater Patient is available for follow-up for 36 months and is willing and able to comply with all follow-up requirements Patient is willing and able to provide signed informed consent Exclusion Criteria: Any subject meeting any of the following criteria will be excluded from the study. Target vessel previously treated with a stent Target lesion within 1.5 cm of the ostium of the SFA Rutherford Classification Category 0,1,5 or 6 Inability to tolerate antithrombotic or antiplatelet therapies Pregnancy (female of child-bearing age confirmed pregnant) Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up. Serum creatinine > 2.5 mg/dL Myocardial infarction or stroke within 30 days of treatment date Known hypercoagulable state Known bleeding diathesis Untreated angiographically-evident thrombus in target vessel Patients currently enrolled in any other clinical trial

Ages Eligible for Study
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Minimum Age: 35 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 |
| --- | --- |
| Other: PAD<br>This is a prospective single-arm multi-center clinical trial designed to evaluate the safety and efficacy of the Flexible Stenting Solutions Flext Stent® Femoropopliteal stenting system in subjects with lower limb peripheral arterial desease (PAD). Subjects targeted for enrollment must have a single de-novo lesion located in the superficial femoral artery and/or proximal popliteal artery with at > 70% stenosis. Subjects must meet all enrollment criteria and provide written informed consent prior to participation in the study. | Device: FlexStent® Femoropopliteal Self Expanding Stent System<br>* Transcatheter over guidewire placement of an intravascular stent(s)<br>* Other names: OPEN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary safety endpoint is freedom from all cause death, TLR, or index limb amputation through 30 days. | The primary safety endpoint is defined as freedom from all cause death, index limb amputation and target lesion revascularization (TLR) through 30 days. The proportion of patients remaining free from this composite endpoint will be compared to a safety performance goal for bare nitinol stents. | 30 Days | 
| The primary efficacy endpoint is vessel patency at 12 months. | The primary efficacy endpoint is vessel patency at 12 months. Vessel patency is defined as freedom from a greater than 50% restenosis in the stented segment as determined by the DUS peak systolic velocity ratio (PSVR) comparing data within the treated segment to the proximal normal arterial segment and freedom from clinically-driven TLR within the stented segment within 1 year of the procedure. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stent, FlexStent, Superficial Femoral Artery or SFA, Self Expanding Stent, Bare Metal Stent