Sapphire II PRO US Clinical Study

Exclusion Criteria

• •1. Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated.
• •2. Subject with known diagnosis of an acute myocardial infarction (AMI) within 72 hours prior to index procedure.
• •3. Subject with known pregnancy or is nursing. Women of child- bearing potential should have a documented negative pregnancy test within 7 days before index procedure.
• •4. Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
• •5. A serum creatinine level \> 2.0 mg/dl within seven days prior to index procedure.
• •6. Cerebrovascular accident (CVA) within the past 6 months.
• •7. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
• •8. Subject has a known left ventricular ejection fraction (LVEF) \<30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary)
• •9. More than two lesions requiring treatment.
• •10. Unprotected left main coronary artery disease.(Greater than 50% diameter stenosis)
• •11. Coronary artery spasm of the target vessel in the absence of a significant stenosis.
• •12. Target lesion with angiographic presence of probable or definite thrombus.
• •13. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch \>2.0 mm in diameter.
• •14. Non-target lesion to be treated during the index procedure meets any of the following criteria:
• •* Located within a bypass graft (venous or arterial)
• •* Left main location
• •* Chronic total occlusion
• •* Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent)
• •* Treatment not deemed a clinical angiographic success