The ELUTES Clinical Trial

The ELUTES Clinical Trial (European Evaluation of Paclitaxel Eluting Stent)

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.

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.