Percutaneous Coronary Intervention (PCI) Outcomes in Community Versus Tertiary Settings

Exclusion Criteria

• •1. The patient is pregnant or breastfeeding.
• •2. Evidence of STEMI within 72 hours of the intended treatment on infarct related or non-infarct related artery.
• •3. Cardiogenic shock on presentation or during current hospitalization.
• •4. Left ventricular ejection fraction less than 20%.
• •5. Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated).
• •6. A platelet count less than 75,000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3,000 cells/mm3.
• •7. Acute or chronic renal dysfunction (creatinine greater than 2.5 mg/dl or less than 150µmol/L).
• •8. Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
• •9. Prior participation in this study.
• •10. Within 30 days prior to the index study procedure, the subject has undergone a previous coronary interventional procedure of any kind. Note: This exclusion criterion does not apply to post-STEMI patients.
• •11. Stroke or transient ischemic attack within the prior 3 months.
• •12. Active peptic ulcer or upper gastrointestinal bleeding within the prior 3 months.
• •13. Subject has active sepsis.
• •14. Unprotected left main coronary artery disease (stenosis greater than 50%).
• •15. In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study.
• •16. Subject has normal or insignificant coronaries (i.e. coronary lesion(s) less than 50% stenosis).
• •17. Any target vessel has evidence of:
• •* excessive thrombus (e.g. requires target vessel thrombectomy)
• •* tortuousity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment,
• •* heavy calcification.
• •18. Any target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
• •19. Any lesion that is located in a saphenous vein graft, however, lesions located within the native vessel but accessed through the graft are eligible.
• •20. The target vessel is in a "last remaining" epicardial vessel (e.g. greater than 2 non-target epicardial vessels and the bypass grafts to these territories \[if present\] are totally occluded).