The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

The ASPECT study is an Asian multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Cook Incorporated Paclitaxel Eluting Supra G 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 must have given signed informed consent.
• Patient agrees to return at one month for an office visit to assess cardiovascular status and at 4-6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.

Exclusion Criteria:

• Patient is less than 18 years old.
• Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• The 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 that.
• Patient is pregnant.
• Patient has other medical condition that may cause the patient to be non-compliant with the protocol, confound the results or is associated with limited life expectancy.