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

Cook Group Incorporated3 sites in 1 country110 target enrollmentFebruary 2009

ConditionsPeripheral Arterial Disease (PAD)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease (PAD)
Sponsor: Cook Group Incorporated
Enrollment: 110
Locations: 3
Primary Endpoint: Primary patency of the treated lesion within the superficial femoral artery
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

November 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cook Group Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Primary patency of the treated lesion within the superficial femoral artery

Time Frame: 1 year after patient enrollment

Secondary Outcomes

Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement(1 year after patient enrollment)