Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s)

Exclusion Criteria

• •CI7. Subject is willing to comply with all protocol-required follow-up evaluation.
• •CE1. Subjects recently suffer from MI (within 1 week), and ECG changes/clinical symptoms consistent with AMI or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) are excluded;
• •CE2. Subjects had an organ transplant or are waiting for an organ transplant;
• •CE3. Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI;
• •CE4. Subjects are undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome;
• •CE5. Subjects with abnormal counts of platelet and white blood cell (WBC): platelet counts less than 100×10E9/L or greater than 700×10E9/L, white blood cells less than 3×10E9/L;
• •CE6. Subjects have confirmed or suspected liver disease, including hepatitis lab results;
• •CE7. Subjects with elevated serum creatinine level \>3.0mg/dL or undergoing dialysis therapy;
• •CE8. Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion;
• •CE9. Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects;
• •CE10. Subjects had any PCI (such as balloon angioplasty, stent, cutting balloon,atherectomy) treatment in target vessels (including collateral) within 12 months prior to baseline;
• •CE11. Subjects plan to undergo PCI or CABG after the baseline PCI;
• •CE12. Subjects have any coronary endovascular brachytherapy treatment previously;
• •CE13. Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thiophenepyridine or aspirin);
• •CE14. Subjects are suffering from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 18 months;
• •CE15. Subjects are currently abusing drugs (such as alcohol, cocaine, heroin, etc);
• •CE16. Subject plan to undergo any operations that may lead to confuse with the programme;
• •CE17. Subjects were participating in another study of drug or medical device which did not meet its primary endpoint;
• •CE18. Subjects plan to pregnant within 18 months after baseline;
• •CE19. Subjects are pregnant or breastfeeding women.
• •AE1. Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, and in-stent stenosis;
• •AE2. Subjects with unprotected left main coronary artery disease (diameter stenosis \>50%);
• •AE3. Subjects have a protected left main coronary artery disease (diameter stenosis\> 50% and left coronary artery bypass surgery), as well as target lesions located in the LAD and LCX;
• •AE4. Subjects with other lesions of clinical significance, may be need intervention within 18 months after baseline.