Sapphire 3 CTO Study

Eligibility Criteria

• 1. Subject is ≥ 18 years of age.
• 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
• 3. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study.
• 4. Subjects must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization with planned stent placement during this index procedure.
• 5. Subject must have at least one de novo or restenotic lesion in native coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow grade of 0 or 1 and is estimated to be at least 3 months in duration by clinical, angiographic, or electrocardiographic criteria.
• 6. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
• 7. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success by visual assessment.
• 8. The Target lesion is intended for stent placement during this index procedure.
• 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