TARGET-PREMIER Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in CAS Treatment

Exclusion Criteria

• •1. Acute myocardial infarction with 1 week or enzyme levels (Creatinkinase or Troponin) demonstrating that either or both enzyme levels have not returned to normal limits at the time of the procedure.
• •2. Target vessel (including branches) PCI within 12 months of the baseline procedure.
• •3. Known congestive heart failure (NYHA III) or left ventricular ejection fraction (LVEF) \<30%
• •4. Patient has current unstable arrhythmias.
• •5. Patient has a history of any coronary arteries brachytherapy.
• •6. Planned surgery within 6 months after index procedure.
• •7. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, white blood cell (WBC) count \<3,000 cells/mm3.
• •8. Impaired renal function (serum creatinine \>2.0mg/dl) or patient on dialysis.
• •9. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attribute to cerebral vascular accident (CVA).
• •10. Patient has a history of bleeding diathesis, contraindication to dual antiplatelet therapy (DAPT).
• •11. Known allergy to protocol-required concomitant medications such as aspirin, or clopidogrel, or heparin and the study stent components such as cobalt, nickel, chromium, rapamycin or similar drugs.
• •12. Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint.
• •13. Other serious medical illness with life expectancy less than 1 year (e.g. cancer, congestive heart failure).
• •14. Patient has immunosuppressive or autoimmune disease, and is receiving or scheduled to immunosuppressive therapy.
• •15. A
• •16. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test with on week before treatment.)
• •17. Women who intend to become pregnant with 12 months after the baseline procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the baseline procedure).
• •18. Patient has received an organ transplant or is on a waiting list for an organ transplant.
• •19. Patient is receiving or scheduled to receive chemotherapy or radiotherapy with 30 days before or any time after the baseline procedure.
• •20. Patient may not be obedient to the clinical investigation plan through the judgment by investigators.