PE PREMIER CHINA CLINICAL TRIAL

Inclusion Criteria

• Clinical Inclusion (CI) Criteria

CI1. Subject must be at least 18 -75 years of age

CI2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed

CI3. Subject is eligible for percutaneous coronary intervention (PCI)

CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia

CI5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)

CI6. Subject is willing to comply with all protocol-required follow-up evaluation

CI7. Subject has a left ventricular ejection fraction (LVEF) >30% as measured within 60 days prior to enrollment

• Angiographic Inclusion (AI) Criteria (visual estimate)

AI1. Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm

AI2. Target lesion(s) length must be ≤34 mm ( Target lesion(s) length must be ≤28 mm for reference vessel diameter (RVD) = 2.25 mm Target lesion(s)) (by visual estimate)

AI3. Target lesion(s) must have visually estimated stenosis ≥50% and 1 and one of the following (stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress test or imaging stress test, or elevated biomarkers) prior to procedure

AI4. Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)

AI5. The first lesion treated must be successfully pre-dilated/pretreated Note: Successful pre-dilatation/pretreatment refers to dilatation with a balloon catheter of appropriate length and diameter, or pretreatment with/or rotational coronary atherectomy, or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.

Exclusion Criteria

• Clinical Exclusion (CE) Criteria

CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with Acute MI (include STEMI and Non- STEMI ) within 1 week

CE2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina

CE3. Subject has received an organ transplant or is on a waiting list for an organ transplant

CE4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure

CE5. Planned PCI (including staged procedures) or CABG after the index procedure

CE6. Subject previously treated at any time with intravascular brachytherapy

CE7. Subject has a known allergy to contrast (that cannot be adequately pre-medicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, Clopidogrel , or aspirin)

CE8. Subject has one of the following (as assessed prior to the index procedure):

• Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 12 months
• Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
• Planned procedure that may cause non-compliance with the protocol or confound data interpretation

CE9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome

CE10. Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.

CE11. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis

CE12. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)

CE13. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions

CE14. Subject has had a history of cerebrovascular accid