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

Other illness

• 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
• 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
• Bleeding tendency due to hemorrhagic diathesis or blood coagulation disorder.
• Allergy to cobalt chrome alloy or contrast agent.

Lab values

• Left ventricular ejection fraction (LVEF) is less than 30% within 30 days before the trial registration.
• Renal dysfunction (Creatinine value exceeds 2.0 mg/dl or in case artificial dialysis).

Other

• \<Clinical exclusion criteria\>
• Patients who cannot be given emergency coronary artery bypass grafting (CABG).
• 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.
• Patients who are pregnant or breast feeding.
• Patients who are taking Cilostazol.
• In cases where the Investigator determines that the patient's participation in the trial is inappropriate.
  • \<Angiographic exclusion criteria\>
• Lesion in left main coronary trunk
• Lesion within 5 mm from the ostium right coronary artery
• Lesion within 5 mm from the ostium left anterior descending/the ostium left circumflex branch
• Bifurcation lesion
• Within 1 year after implementing PCI on the target vessel or its branch
• There are other lesions that require PCI at the time of the procedure
• Type C of ACC / AHA classification

• \<Clinical selection criteria\>
• Patients who have provided written informed consent.
• Patients who have evidence of myocardial ischemia confirmed by subjective symptoms (chest pain etc.), ST change in the electrocardiogram or objective findings.
• Patients who are at least 20 years old.
  • \<Angiographic selection criteria\>
• Single de novo lesion in native coronary arteries
• Target vessel diameter is 2.75 mm to 3.25 mm.
• TIMI flow is 2 or more.
• Angiographic percent diameter stenosis (by visual estimation) is 75% or more in AHA classification