A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™)

Inclusion Criteria

• Patient (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
• Patient is eligible for percutaneous coronary intervention (PCI)
• Patient has documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or documented silent ischemia; or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C)
• Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
• Patient has a left ventricular ejection fraction (LVEF) >=30% as measured within 30 days prior to enrollment
• Patient is willing to comply with all specified follow-up evaluations

Angiographic Inclusion Criteria:

• Target lesion must be a de novo lesion located in a native coronary artery with visually estimated diameter of >=2.25 mm and =50% and 1.

Exclusion Criteria

• Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI)
• Patient has had a known diagnosis of recent MI (within 30 days prior to the index procedure) and has elevated enzymes at the time of the index procedure as follows.
• Patients are excluded if any of the following criteria are met at the time of the index procedure
• If creatine kinase, MB band (CK-MB) >2× upper limit of normal (ULN), the patient is excluded regardless of the creatine kinase (CK) Total.
• If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is >2× ULN.
• If CK Total/CK-MB are not used and Troponin is, the patients are excluded if the following criterion is met at the time of the index procedure.
• Troponin >1× ULN with at least one of the following.
• Patient has ischemic symptoms and electrocardiogram (ECG) changes indicative of ongoing ischemia (e.g., >1mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB]);
• Development of pathological Q-waves in the ECG
• Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

Note: For patients who have had a recent MI, CK Total/CK-MB (or Troponin if CK Total/CK-MB are not used) must be documented prior to enrolling the patient

• Patient has received an organ transplant or is on a waiting list for an organ
• transplant
• Patient is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• Patient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
• Patient is receiving chronic (>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome
• Patient has a platelet count 700, 000 cells/mm3
• Patient has a white blood cell (WBC) count =2.0 mm in diameter
• Involves a clinically significant side branch <2.0 mm in diameter that has a clinically significant stenosis at the ostium
• TIMI flow 0 (total occlusion) or TIMI flow 1 prior to wire crossing
• Excessive tortuosity proximal to or within the lesion
• Extreme angulation proximal to or within the lesion
• Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified
• Restenotic from previous intervention
• Thrombus, or possible thrombus, present in the target vessel
• Patient has an additional clinically significant lesion(s) in the target vessel for which an intervention within 12 months after the index procedure is likely to be required