Sapphire 3 CTO Study

Clinical Inclusion Criteria:

1. Subject is ≥ 18 years of age.

2. Subject or a legally authorized representative must provide written informed consentprior to any study related procedures.

3. Subject must agree not to participate in any other clinical study duringhospitalization for the index procedure that would interfere with the endpoints ofthis study.

4. Subjects must have a single or double vessel coronary artery disease and clinicalevidence of ischemic heart disease, such as stable / unstable angina or silentischemia attributed to the CTO target vessel and is scheduled for clinicallyindicated percutaneous revascularization with planned stent placement during thisindex procedure. Angiographic Inclusion Criteria

5. Subject must have at least one de novo or restenotic lesion in native coronaryarteries with Thrombolysis In Myocardial Infarction (TIMI) flow grade of 0 or 1 andis estimated to be at least 3 months in duration by clinical, angiographic, orelectrocardiographic criteria.

6. A maximum of two lesions, including at least one target lesion, in up to twocoronary arteries.

7. Treatment of non-target lesion, if any, must be completed prior to treatment oftarget lesion and must be deemed a clinical angiographic success by visualassessment.

8. The Target lesion is intended for stent placement during this index procedure.

Clinical Exclusion Criteria:

1. Subject with a known hypersensitivity or contraindication to aspirin, heparin,bivalirudin, anti-platelet medications, or sensitivity to contrast media whichcannot be adequately pre-medicated.

2. Evidence of acute myocardial infarction (MI) within 72 hours prior to the intendedtreatment 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 shouldhave 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 withan unapproved device, atherectomy, laser, cutting balloon or thrombectomy during theindex 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 6months.

8. Subject has a known left ventricular ejection fraction (LVEF) <30% (LVEF may beobtained at the time of the index procedure if the value is unknown, if necessary). Angiographic Exclusion Criteria

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 TIMIthrombus grade 3 or 4.

13. By visual estimation, target lesion involves a bifurcation requiring treatment withmore 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 tothe 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 thefollowing 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 morethan 40% diameter stenosis.

17. Non-target lesion to be treated during the index procedure meets any of thefollowing 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 1stent)

• Treatment not deemed a clinical angiographic success