Sapphire 3 CTO 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. Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment defined as CK-MB or troponin greater than 1X the upper limit of normal (ULN).
• •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 prior to the use of the Study Device 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 of TIMI thrombus grade 3 or 4.
• •13. By visual estimation, target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch \>2.25 mm in diameter.
• •14. Previous coronary interventional procedure of any kind within the 30 days prior to the procedure in the target vessel.
• •15. Target vessel with a patent bypass graft from prior coronary bypass surgery.
• •16. Previous stenting (drug-eluting or bare metal) in the target vessel unless all the following conditions are met:
• •* It has been at least 9 months since the previous stenting.
• •* That target lesion is at least 15 mm away from the previously placed stent. Total occlusions involving an in-stent segment are excluded.
• •* The previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis.
• •17. 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 (CTO)
• •* Is moderately to severely calcified.
• •* Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent)
• •* Treatment not deemed a clinical angiographic success