Zilver® Flex™ Vascular Stent Study

Cook Group

Status

Completed

Conditions

Peripheral Arterial Disease (PAD)

Treatments

Device: Zilver® Flex™ Vascular Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00827619

08-009

100005, ZBLL

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.