Status:
COMPLETED
Zilver® Flex™ Vascular Stent Study
Lead Sponsor:
Cook Group Incorporated
Conditions:
Peripheral Arterial Disease (PAD)
Eligibility:
All Genders
18+ years
Phase:
NA
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00827619
Start Date
February 1 2009
End Date
November 1 2015
Last Update
December 4 2015
Active Locations (3)
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1
Herz-Zentrum
Bad Krozingen, Germany, 79189
2
Gemeinschaftspraxis
Leipzig, Germany, 04177
3
Universitatsklinikum Magdeburg
Magdeburg, Germany, 39120