Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions

Exclusion Criteria

• •1. Known hypersensitivity to paclitaxel
• •2. Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
• •3. Previous or planned use of both the study stent and a non-study stent (i.e., commercial stent) in the treatment of the target vessel
• •4. Previous or planned treatment with intravascular brachytherapy in the target vessel
• •5. Planned CABG ≤9-months post-index procedure
• •6. MI within 72 hours prior to the index procedure and/or creatine kinase(CK) \>2x the local laboratory's ULN unless CK-MB is \<2x ULN.
• •7. Cerebrovascular Accident (CVA) within the past 6 months
• •8. Cardiogenic Shock
• •9. Acute or chronic renal dysfunction
• •10. Contraindication to ASA, or to both clopidogrel and ticlopidine
• •11. Patient is currently on warfarin or it is anticipated that treatment with warfarin will be required during any period within 6 months after the index procedure.
• •12. Leukopenia
• •13. Thrombocytopenia
• •14. Active peptic ulcer or active gastrointestinal (GI) bleeding
• •15. Known allergy to stainless steel
• •16. Any prior true anaphylactic reaction to contrast agents
• •17. Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
• •18. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
• •19. Male or female with known intention to procreate within 3 months after the index procedure
• •20. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating
• •21. Life expectancy of less than 24-months due to other medical condition
• •22. Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
• •23. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
• •1. Unprotected left main coronary artery disease (patient with protected left main disease can be enrolled only if the target lesion is in the RCA)
• •2. Target lesion is ostial in location (within 3.0 mm of vessel origin)
• •3. Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate
• •4. Target lesion and/or target vessel proximal to the target lesion is tortuous
• •5. Target lesion is located within or distal to a \>60 degree bend in the vessel
• •6. Target lesion involves a bifurcation with a diseased (\>50% stenotic)branch vessel \>2.0 mm in diameter
• •7. Target lesion is totally occluded (TIMI flow\<1) at baseline
• •8. Angiographic presence of probable or definite thrombus
• •9. Pre-treatment of the target vessel at the index procedure is not allowed with any device
• •10. A previously treated lesion within the target vessel:
• •* \<15 mm from the target lesion (visual estimate)
• •* Performed \</= 6 months from index procedure
• •* \>30% residual stenosis after previous treatment
• •11. Predilation with a balloon catheter of the target lesion and/or target vessel is not allowed.