Treatments and/or Procedures

Study Criteria

Inclusion Criteria:

  -  • The patient must be ≥18 of age;

       -  Symptomatic ischemic heart disease and/or objective evidence of myocardial
          ischemia including chronic stable coronary artery disease, or acute coronary
          syndrome including non-ST-elevation and ST-elevation myocardial infarction;

       -  Acceptable candidate for CABG;

       -  The patient is willing to comply with specified follow-up evaluations;4.Patients
          who agree to accept the follow-up visits.

       -  Patients can understand the study objectives psychologically and linguistically
          and show the sufficient compliance to the study protocol. Patients present
          acceptance of the risks and benefits described in the informed consent form.

Angiographic Inclusion criteria:

  -  At least one lesion with a diameter stenosis >70% or more suitable for coronary stent
     implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm;

  -  Patients with multi-lesion or multi-vessel coronary disease, must have successful
     treatment (<30% diameter stenosis visual estimate) of the first treated lesion prior
     to treatment of other lesions at the same brand of stent. Staged (planned) procedures
     must be performed within 30 days of the index procedure.

Exclusion Criteria:

  -  General Exclusion Criteria

       -  Pregnant or nursing patients and those who plan pregnancy in the period up to 1
          year following index procedure.

       -  Patient has a history of bleeding diathesis or coagulopathy or patients in whom
          anti-platelet and/or anticoagulant therapy is contraindicated or in which patient
          will not be able to comply with dual antiplatelet therapy for at least 1 year;

       -  Patient has other medical illness (e.g., cancer, known malignancy, congestive
          heart failure, organ transplant recipient or candidate) or known history of
          substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance
          with the protocol, confound the data interpretation or is associated with a
          limited life expectancy (i.e., less than 1 year);

       -  Left ventricular function <40%;

       -  Cardiogenic shock or hemodynamic compromise requiring pressors and/or inotropes
          or mechanical support;

       -  Patient has a known hypersensitivity or contraindication to aspirin, heparin,
          clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, Rapamycinry ,
          styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast
          sensitivity that cannot be adequately pre-medicated;

       -  Any significant medical condition which in the Investigator's opinion may
          interfere with the patient's optimal participation in the study;

       -  Currently participating in another investigational drug or device study or
          patient in inclusion in another investigational drug or device study during
          follow-up.

       -  Existing impairment in liver and kidney.

       -  Extremely tortuous and/or calcification lesions.

Angiographic exclusion criteria:

• Two or more chronic total occlusions in the proximal half of the epicardial coronary
artery which cannot be recannalized.