A Randomized, Double-blind Study to Assess Paclitaxel-eluting Stents in Treatment of Longer Lesions

Inclusion Criteria:

• General Inclusion Criteria

1. Patient >or= 18 years old

2. Eligible for percutaneous coronary intervention

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

4. Acceptable candidate for CABG

5. Patient (or legal guardian) understands the study requirements and the treatmentprocedures and provides written Informed Consent before any study-specific testsor procedures are performed

6. Willing to comply with all specified follow-up evaluations

• Angiographic Inclusion Criteria

1. Target lesion located within a single native coronary vessel

2. Target lesion randomized to treatment with the study device may be composed ofmultiple lesions but must be completely coverable by up to 2 study stents (maximum allowable stent length of 48 mm).

3. Cumulative target lesion length is >or= 18 mm and <or= 40 mm (visual estimate)

4. RVD of >or= 2.5 mm to <or= 3.75 mm (visual estimate)

5. Target lesion diameter stenosis >or=50% (visual estimate)

6. Target lesion is de novo

Exclusion Criteria:

• General Exclusion Criteria:

1. Known sensitivity to paclitaxel

2. Any previous or planned treatment with any anti-restenotic drug-coated ordrug-eluting coronary stent (Note: previous or planned treatment with heparin orphosphorylcholine coated stents is acceptable, as long as the procedure with thestent meets the protocol defined criteria for staged procedures)

3. Previous or planned treatment with intravascular brachytherapy in the targetvessel

4. MI within 72 hours prior to the study procedure and/or CK-MB >2x the locallaboratory's upper limits of normal (refers to a measured value on the day of thestudy procedure)

5. Left ventricular ejection fraction <25%

6. Cerebrovascular Accident within the past 6 months

7. Acute or chronic renal dysfunction (creatinine >1.7 mg/dl or >150 µmol/L)

8. Contraindication to ASA, or to both clopidogrel and ticlopidine

9. Leukopenia (leukocyte count <3.5 x 109/liter)

10. Thrombocytopenia (platelet count <100,000/mm3)

11. Active peptic ulcer or active gastrointestinal bleeding

12. Known allergy to stainless steel

13. Any prior true anaphylactic reaction to contrast agents

14. Known anaphylactoid or other non-anaphylactic allergic reactions to contrastagents that cannot be adequately pre-medicated prior to the study procedure

15. Patient is currently taking colchicine

16. Patient is currently, or has been treated with paclitaxel within 12 months of thestudy procedure

17. Female of childbearing potential with a positive pregnancy test within 7 daysbefore the study procedure, or lactating, or intends to become pregnant duringthe study

18. Life expectancy of less than 24 months due to other medical conditions

19. Co-morbid condition(s) that could limit the patient's ability to participate inthe study, compliance with follow-up requirements or impact the scientificintegrity of the study

20. Currently participating in another investigational drug or device study that hasnot completed the primary endpoint or that clinically interferes with theendpoints of this study

• Angiographic Exclusion Criteria

1. Left main coronary artery disease (stenosis >50%), whether protected orunprotected

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

3. Target lesion(s) and/or target vessel proximal to the target lesion(s) ismoderately or severely calcified by visual estimation

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

5. Target lesion involves a bifurcation with a diseased (>50% stenotic) branchvessel >2.0 mm in diameter

6. Target lesion is totally occluded Thrombolysis in MI (TIMI flow <or= 1)

7. Angiographic presence of probable or definite thrombus

8. Target vessel will be pre-treated with an unapproved device, directional orrotational coronary atherectomy, laser, cutting balloon or transluminalextraction catheter immediately prior to stent placement