firehawk™ coronary stent system in the treatment of coronary chronic total occlusion lesion(s)

Conditions: Drug-Eluting Stents; Percutaneous Coronary Intervention; Tomography, Optical Coherence

Summary: 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.

Eligibility criteria:
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.