Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study

Inclusion Criteria:

- Must be an acceptable candidate for percutaneous coronary intervention (PCI),
stenting, and emergent coronary artery bypass graft (CABG) surgery

- Must have clinical evidence of ischemic heart disease, stable or unstable angina,
and/or a positive functional study

- Must require treatment of either a) a single target lesion amenable to treatment OR b)
two target lesions located in separate target vessels

- Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)

Exclusion Criteria:

- Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin,
thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer
coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately
pre-medicated

- History of an allergic reaction or significant sensitivity to drugs such as
zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative

- History of a stroke or transient ischemic attack (TIA) within the prior 6 months

- Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months

- History of bleeding diathesis or coagulopathy or will refuse blood transfusions

- Concurrent medical condition with a life expectancy of less than 12 months

- Currently participating in an investigational drug or another device trial that has
not completed the primary endpoint

- Documented left ventricular ejection fraction (LVEF) < 30% at the most recent
evaluation