Zilver® Flex™ Vascular Stent Study

Study Overview
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Brief Summary
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This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for commercial use. The study is designed as a single arm non-randomized post-approval study.

Official Title
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Evaluation of the Zilver® Flex™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery

Conditions
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Peripheral Arterial Disease (PAD)

Intervention / Treatment
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* Device: Zilver® Flex™ Vascular Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are at least 18 years old and have at least 1 stenotic atherosclerotic lesion of the above-the-knee femoropopliteal artery may be considered for enrollment. To be enrolled in the study, the lesion must be the appropriate size and and no prior stent in the target vessel may be present. Exclusion Criteria: Patient is < 18 years of age. Patient is pregnant or breast-feeding. Patient is simultaneously participating in an investigational drug or device study. The patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrollment in this study. Patient has had previous stenting of the target vessel. Patient has a medical condition or disorder that would limit life expectancy to less than 1 year or that may cause noncompliance with the protocol or confound the data analysis. Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, or nitinol that, in the opinion of the investigator, cannot be adequately premedicated.

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 |
| --- | --- |
| Other: 1<br>single arm non-randomized post-market study | Device: Zilver® Flex™ Vascular Stent<br>* Stenting of the Above-the-Knee Femoropopliteal Artery<br>* Other names: Implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency of the treated lesion within the superficial femoral artery |  | 1 year after patient enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement |  | 1 year after patient enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease