Status:
COMPLETED
The ELUTES Clinical Trial
Lead Sponsor:
Cook Group Incorporated
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
ELUTES is a European multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Paclitaxel Eluting V-Flex Plus coronary stent to reduce restenosis in the coronar...
Eligibility Criteria
Inclusion
- Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
- Patient must be an acceptable candidate for coronary artery bypass surgery.
- Patient or legal guardian must have signed informed consent.
- Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.
Exclusion
- Patient must be less than 18 years old.
- Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
- Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
- Women of child bearing potential.
- Patient has other medical condition that may cause non-compliance with the protocol, confound the results, or is associated with limited life expectancy.
- Patient has been diagnosed with a myocardial infarction within 72 hours prior to procedure.
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
November 1 2001
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00225654
Start Date
January 1 2000
End Date
November 1 2001
Last Update
February 1 2012
Active Locations (1)
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1
Contact Sponsor
Bloomington, Indiana, United States