"JACTAX" Trial Drug Eluting Stent Trial

Exclusion Criteria

• •1. The patient has a life expectancy of less than 24 months due to another medical condition
• •2. Patient has a history of hypersensitivity to paclitaxel or structurally related compounds
• •3. Patient exhibits cardiogenic shock (systolic pressure \<80 mmHg and PCWP\> 20mm Hg or cardiac index \<1.8 liters/m or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure \>80 mmHg) for any time within 24 hours prior to index procedure
• •4. Patient demonstrates evidence of acute or chronic renal dysfunction (serum creatinine \>2.0 mg/dl or 177umol/l)
• •5. Planned cardiac surgery procedure \<= 9 months post index procedure
• •6. Patient demonstrates evidence of a myocardial infarction (elevated CK, CKMB or Troponin) within 72 hours prior to index procedure and/or CK\> 2X local lab's ULN, unless CK-MB is \<2X ULN
• •7. Patient exhibits acute ST segment elevation MI (STEMI) within 72 hours prior to the index procedure
• •8. CVA including stroke or TIA within 3 months
• •9. Patient demonstrates evidence of leukopenia
• •10. Patient demonstrates evidence of thrombocytopenia or thrombocytosis
• •11. Patient is contraindicated to ASA, clopidogrel or ticlopidine
• •12. Patient is currently on warfarin, or possibility of treatment with warfarin during the following 6 months post index procedure
• •13. Patient has been treated with paclitaxel or other chemotherapeutic agents within 12 months prior to planned index procedure
• •14. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9 months after the index procedure
• •15. Patient has received a drug eluting stent within 12 months prior to planned index procedure
• •16. Previous or planned treatment with intravascular brachytherapy in target vessel
• •17. Known allergy to stainless steel
• •18. Male or female with known intention to procreate within 3 months after the index procedure
• •19. Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating or intends to become pregnant during the 12 months post index procedure
• •1. Evidence of probable or definite thrombus of the study vessel, based on angiography or IVUS
• •2. Study lesion is totally occluded (TIMI flow \<= 1) either at baseline or before pre-dilatation
• •3. Study lesion, or the study vessel proximal to the study lesion is moderately or severely calcified by visual estimate
• •4. Study lesion is ostial in location (within 3.0 mm of vessel origin)
• •5. Study lesion involving arterial segments with highly tortuous anatomy or where lesion is located within or distal to a \>60 degree bend in the vessel
• •6. Study lesion involves a bifurcation with a diseased (\>50% stenotic) branch vessel \>2.0 mm in diameter
• •7. Left main coronary artery disease (stenosis \>50%) branch vessel \> 2.0 mm in diameter
• •8. Target lesion length \>20 mm based on visual estimate by operator
• •9. Target vessel diameter \>3.5 mm based on visual estimate by operator
• •10. Target vessel diameter \<2.75 mm based on visual estimate by operator
• •11. Pre-treatment of the target lesion (excluding predilation) with another interventional device