The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions

Inclusion Criteria

• Patient must be at least 18 years of age
• Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
• For patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide 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 or documented silent ischemia; or unstable angina pectoris
• 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 protocol-required follow-up evaluations

Angiographic Inclusion Criteria (visual estimate):

• Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) >=2.50 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 (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.
• Patients are excluded if any of the following criteria are met at time of the index procedure.
• If creatine kinase-myoglobin band (CK-MB) >2× upper limit of normal (ULN), the patient is excluded regardless of 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, patients are excluded if the following criterion is met at time of index procedure.
• Troponin >1× ULN with at least one of the following.
• Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, >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.

Note: For patients with unstable angina or 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/randomizing 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 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 (eg, 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 platelet count 700,000 cells/mm3
• Patient has white blood cell (WBC) count =2.0 mm in diameter by visual estimate
• Involves a clinically significant side branch 50% diameter stenosis)
• Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX
• Patient has an additional clinically significant lesion(s) in target vessel for which an intervention within 12 months after the index procedure is likely to be required
• Patient has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 stent.