Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2009-02-28
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
single arm non-randomized post-market study
Zilver® Flex™ Vascular Stent
Stenting of the Above-the-Knee Femoropopliteal Artery
Interventions
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Zilver® Flex™ Vascular Stent
Stenting of the Above-the-Knee Femoropopliteal Artery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Jens Ricke, MD
Role: PRINCIPAL_INVESTIGATOR
Universitatsklinikum Magdeburg
Locations
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Herz-Zentrum
Bad Krozingen, , Germany
Gemeinschaftspraxis
Leipzig, , Germany
Universitatsklinikum Magdeburg
Magdeburg, , Germany
Countries
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Other Identifiers
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100005, ZBLL
Identifier Type: -
Identifier Source: secondary_id
08-009
Identifier Type: -
Identifier Source: org_study_id