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

Clinical Inclusion Criteria: * CI1. Subject must be at least 18 years of age; * CI2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; * CI3. Subject is eligible for percutaneous coronary intervention (PCI); * CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia; * CI5. Subjects are eligible candidates for coronary artery bypass graft surgery (CABG); * CI6. Left ventricular ejection fraction (LVEF) within 60 days ≥ 35%; Exclusion Criteria; * CI7. Subject is willing to comply with all protocol-required follow-up evaluation. Angiographic Inclusion Criteria (visual estimate): * AI1. Target lesions must be new and have a visually estimated reference diameter ≥2.25 mm and ≤4.0 mm in autologous coronary artery; * AI2. Target lesions must be \< 100 mm in length (visual estimate) and the number of implanted stents is less than 4; * AI3. Target lesions must be visually complete occlusion and longer than 4 weeks; * AI4. Target lesions must be able to pass and be successfully expanded; Clinical Exclusion Criteria: * 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. Angiographic Exclusion Criteria (visual estimate): * 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.