BioFreedom US IDE Feasibility Trial

Inclusion Criteria: * Individual is ≥ 18 years of age * Individual must have clinical evidence if ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study; * Individual must be an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery * Individual is competent and willing to provide informed consent to participate in the trial Exclusion Criteria: * A known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, or a sensitivity to contrast media that cannot be adequately pre-medicated; * History or known allergic reaction or significant sensitivity to drugs similar to BA9; * A platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, or a WBC \< 3,000 cells/mm3; * A creatinine level \> 2.5 mg/dL; * Evidence of an acute myocardial infarction with 72 hours of the intended stenting (defined as: Q wave or non-Q wave myocardial infarction having a Troponin either I or T pre-procedure elevated above the Institution's upper limit of normal); * Previous or planned PCI of any vessel within 30 days pre or post procedure; * Patient unable to take clopidogrel for 3 months or patient who have comorbidities that would prohibit the cessation of clopidogrel at 3 months; * Planned adjunctive treatment during the intended stenting (eg balloon valvuloplasty, percutaneous endovascular intervention, etc) * During the intended or index procedure the target lesion(s) requires treatment with a device other than a plain old balloon prior to stent placement (such as, but not limited to, cutting balloon, directional atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc); * History of documented prior stroke within 6 months of the intended procedure; * Active peptic ulcer or upper gastrointestinal bleeding documented within the prior 6 months; * History of active bleeding diathesis or coagulopathy or will refuse blood transfusion; * Individual is pregnant, nursing or planning to be pregnant; * Any previous or planned treatment of the target vessel(s) with anti-restenotic therapies including, but not limited to brachytherapy; * Concurrent medical condition with a life expectancy of less than 12 months or individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study; * Individual is currently enrolled in another investigational drug or device trial. If, however, if investigational trial device or drug becomes commercially available, these trials are not considered investigational; * Previous ACS within 9 months of pre or post procedure