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

A Prospective, Open Label, Multi-center Trial of Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s) by Optical Coherent Tomography (OCT) and Coronary Angiography

This study is a prospective, multi-center, open-label, randomized controlled clinical trial,aims to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting coronary stent system with abluminal grooves containing a biodegradable polymer (Firehawk™) comparing the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with total coronary occlusion lesion(s).

This study will recruit 196 subjects with total coronary occlusion lesion(s) in coronary arteries ≥2.25 mm to ≤4.0 mm in diameter and ≤100 mm in length (by visual estimate) in no more than 10 research centers in China. All participants met the inclusion criteria will be 1:1 randomized to receive Firehawk™ sirolimus target-eluting coronary stent or XIENCE everolimus-eluting coronary stent.

Optical Coherent Tomography (OCT) sub study: the first 44 consecutive subjects who consented to participate in the OCT sub study will undergo OCT assessment at 3 months and 12 months post index procedure. The OCT sub study will be performed in 3-5 pre-selected sites. The clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months,and 2-5 years post-index procedure.The primary endpoint is in-stent late lumen loss at 12 months post-index procedure.The secondary endpoint is neo-intimal thickness by Optical Coherent Tomography (OCT) at 3 months post-index procedure.

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.