The ENDEAVOR Pharmacokinetic (PK) Registry: The Medtronic Endeavor Drug Eluting Coronary Stent System

Exclusion Criteria

• •A known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine or clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
• •History of an allergic reaction or significant sensitivity to drugs similar to ABT-578, rapamycin, tacrolimus, everolimus, or any other analog or derivative.
• •A platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³.
• •A creatinine level \> 2.0 mg/dL within seven days prior to index procedure. Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave myocardial infarction having creatine kinase \[CK\] enzymes greater than or equal to 2 X the upper laboratory normal with the presence of a creatine kinase myocardial-band isoenzyme \[CK-MB\] elevated above the institution's upper limit of normal).
• •Previous percutaneous coronary intervention (PCI) of the target vessel within 9 months pre-procedure.
• •Planned PCI of any vessel within 30 days post-procedure.
• •During the index procedure, the target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to: cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.).
• •History of a stroke or transient ischemic attack 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. Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to, brachytherapy.
• •Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (IVUS) or other coronary artery imaging procedures.