The First-In-Man Pilot Study of Firehawk

Inclusion criteria

• 18-75 years of age, males or non-pregnant females;
• With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
• Total number of target lesion is 1;
• Target lesion length ≤ 30mm (Visual); target lesion diameter between 2.25mm to 4.0mm;
• Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
• Each target lesion may be covered by a single stent;
• Patients with indications for coronary artery bypass graft surgery;
• To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

Exclusion criteria

• Within 1 month of any acute myocardial infarction;
• Chronic total occlusion (TIMI grade 0 flow before surgery), left main coronary artery disease, mouth lesions, multiple-vessel lesions, branch diameter ≥ 2.5mm bifurcation lesions and vascular lesions of the bridge;
• Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
• In-stent Restenosis lesions;
• Intracoronary implantation of any branding stents within 1 year;
• Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or <40% (ultrasound or left ventricular angiography);
• Preoperative renal function serum creatinine >2.0mg/DL;
• Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
• Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
• The patient's life expectancy is less than 12 months;
• Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
• Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
• Heart transplantation patients.