Zilver® Flex™ Vascular Stent Study

Launched by COOK GROUP INCORPORATED · Jan 22, 2009

Keywords

ClinConnect Summary

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Gender

ALL

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.