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

General Inclusion Criteria:

1. Patient is ≥18 years old.

2. Eligible for percutaneous coronary intervention (PCI)

3. Documented stable angina pectoris or unstable angina pectoris with documentedischemia, or documented silent ischemia

4. Left ventricular ejection fraction (LVEF) of ≥25%

5. Acceptable candidate for coronary artery bypass grafting (CABG)

6. Patient or legal guardian understands the study requirements and the treatmentprocedures and provides written Informed Consent before any study-specific tests orprocedures are performed

7. Willing to comply with all specified follow-up evaluations Angiographic Inclusion Criteria:

8. Only one lesion appropriate for direct stenting (typically covered by one 24 mm stentor shorter), may be treated with the study stent. However, one additional lesion in anon-target vessel may be treated during the index procedure with a commerciallyavailable bare metal stent, heparin-coated stent or TAXUS Express stent.

9. Target lesion located within a single native coronary vessel

10. Target lesion enrolled for treatment may be composed of multiple lesions(not more than 10mm between diseased segments) but must be completely covered by one study stent.

11. Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate) and istypically considered appropriate for direct stenting

12. RVD of ≥2.5 mm to ≤4.0 mm (visual estimate)

13. Target lesion diameter stenosis ≥50% (visual estimate)

14. Target lesion is de novo (i.e., a coronary lesion not previously treated)

General Exclusion Criteria:

1. Known hypersensitivity to paclitaxel

2. Any previous, concurrent or planned treatment with a non-study anti-restenoticdrug-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 thelocal 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 warfarinwill 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 chemotherapeuticagents 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 indexprocedure

20. Female of childbearing potential with a positive pregnancy test within 7 days beforethe 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 thestudy, compliance with follow-up requirements or impact the scientific integrity ofthe study

23. Currently participating in another investigational drug or device study that has notcompleted the primary endpoint or that clinically interferes with the endpoints ofthis study. Angiographic Exclusion Criteria:

24. Unprotected left main coronary artery disease (patient with protected left maindisease can be enrolled only if the target lesion is in the RCA)

25. Target lesion is ostial in location (within 3.0 mm of vessel origin)

26. Target lesion and/or target vessel proximal to the target lesion is moderately orseverely calcified by visual estimate

27. Target lesion and/or target vessel proximal to the target lesion is tortuous

28. Target lesion is located within or distal to a >60 degree bend in the vessel

29. Target lesion involves a bifurcation with a diseased (>50% stenotic)branch vessel >2.0mm in diameter

30. Target lesion is totally occluded (TIMI flow<1) at baseline

31. Angiographic presence of probable or definite thrombus

32. Pre-treatment of the target vessel at the index procedure is not allowed with anydevice

33. 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 notallowed.