Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions

Exclusion Criteria

• •1. Acute myocardial infarction Patients whose CK-MB or troponin exceeds the facility reference upper limit and have at least one of the following is confirmed are excluded as acute myocardial infarction.
• •* Ischemic symptoms and Electrocardiographic findings showing continuous ischemia (eg, ST segment elevation or depression above 1 mm in contiguous leads, or the appearance of a new left bundle branch block).
• •* Pathological Q waves on electrocardiogram
• •* Myocardial necrotic focus or wall motion abnormality newly confirmed in diagnostic imaging
• •2. Patients who cannot be given emergency coronary artery bypass grafting (CABG).
• •3. Patients who cannot be administered antiplatelet drugs. The following cases are conceivable.
• •* Significant intracranial hemorrhage, gastrointestinal bleeding, urinary tract hemorrhage etc. within the last 6 months
• •* Surgical operation is planned that requires discontinuation of DAPT after the procedure
• •* Anticoagulation therapy is underway and the risk of bleeding is high
• •4. Bleeding tendency due to hemorrhagic diathesis or blood coagulation disorder.
• •5. Left ventricular ejection fraction (LVEF) is less than 30% within 30 days before the trial registration.
• •6. Renal dysfunction (Creatinine value exceeds 2.0 mg/dl or in case artificial dialysis).
• •7. Allergy to cobalt chrome alloy or contrast agent.
• •8. Patients who are participating in or will planning to participate in other clinical studies that may have clinical implications for the evaluation of this trial.
• •9. Patients who are pregnant or breast feeding.
• •10. Patients who are taking Cilostazol.
• •11. In cases where the Investigator determines that the patient's participation in the trial is inappropriate.
• •1. Lesion in left main coronary trunk
• •2. Lesion within 5 mm from the ostium right coronary artery
• •3. Lesion within 5 mm from the ostium left anterior descending/the ostium left circumflex branch
• •4. Bifurcation lesion
• •5. Within 1 year after implementing PCI on the target vessel or its branch
• •6. There are other lesions that require PCI at the time of the procedure
• •7. Type C of ACC / AHA classification