The ELUTES Clinical Trial
Not Applicable
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00225654
- Lead Sponsor
- Cook Group Incorporated
- 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 coronary artery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Angiographic in-stent % diameter stenosis and late loss at follow up.
- Secondary Outcome Measures
Name Time Method Major adverse events Total lesion revascularization
Trial Locations
- Locations (1)
Contact Sponsor
🇺🇸Bloomington, Indiana, United States