Table 1.

Inclusion and exclusion criteria.

Inclusion criteria: clinical and angiographic CI1. Subject must be at least 18 years of age. CI2. Subject (or legal guardian) indicates understanding of the trial requirements and the treatment procedures and provides written informed consent before procedures are performed. CI3. Subject is eligible for percutaneous coronary intervention (PCI). CI4. Subject has symptomatic coronary artery disease or silent ischemia with objective evidence of ischemia or acute coronary syndromes and qualifies for PCI. CI5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG). CI6. Subject has a left ventricular ejection fraction (LVEF) >34% as measured within 60 days prior to enrollment. CI7. Subject is willing to comply with all protocol-required follow-up evaluations. AI1. Subject has one or more coronary artery stenosis of ⩾50% in a native coronary artery with visually estimated reference vessel diameter (RVD) ⩾2.50 mm and ⩽4.0 mm. AI2. Coronary anatomy is likely to allow delivery of a study stent to the target lesions(s). Exclusion criteria: clinical and angiographic CE1. Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (eg, cobalt chromium alloy, stainless steel, all P2Y12 inhibitors, or aspirin). CE2. Planned surgery within 30 days after the index procedure. CE3. Subject has one of the following (as assessed prior to the index procedure):  • Other serious medical illness (eg, cancer, congestive heart failure) with estimated life expectancy of less than 12 months.  • Current problems with substance abuse (eg, alcohol, cocaine, heroin, etc).  • Planned procedure that may cause noncompliance with the protocol or confound data interpretation. CE4. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. CE5. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint, or that, in the opinion of the investigator, may cause noncompliance with the protocol or confound data interpretation. CE6. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure. CE7. Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure). CE8. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential). Note: No restrictions are placed on the total number of treated lesions, treated vessels, lesion length, or number of stents implanted. AE1. Target lesion meets any of the following criteria:  • Restenosis from previous intervention. AE3. Subject has protected left main coronary artery disease. AE4. Subject has an additional clinically significant lesion(s) in the target vessel for which an intervention within 12 months after the index procedure may be required.