The EVOLVE China Clinical Trial

Inclusion Criteria

• CI1. Subject must be 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
• AI1. Target lesion(s) must be de novo lesion 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 (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 or imaging stress test, or elevated biomarkers prior to the 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 predilated/pretreated

Exclusion Criteria

• CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI .
• CE2. Subject with unstable angina or recent MI (within 1 week) must have CK/CK-MB or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure:
• If CK MB >2× upper limit of normal (ULN), the subject is excluded regardless of the CK Total.
• If CK Total >2× ULN, either CK-MB or troponin must be drawn and the subject is excluded if either CK-MB or troponin is abnormal.
• If neither CK Total or CK MB is drawn but troponin is, the subject is excluded if troponin >1× ULN and the subject has at least one of the following:
• Subject has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., >1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB])
• Development of pathological Q waves in the ECG or
• Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
• CE3. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, or intractable ventricular arrhythmias or ongoing intractable angina
• CE4. Subject has received an organ transplant or is on a waiting list for an organ transplant
• CE5. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• CE6. Planned PCI or CABG after the index procedure
• CE7. Subject has a known allergy to 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) and contrast (that cannot be adequately premedicated)
• CE8. Subject has a known condition(s) of the following (as assessed from the time of screening through the day of index procedure):
• Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 24 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, includ