Evaluation of New Specifications (38mm) of FirehawkTM in the Treatment of Coronary Heart Disease

Inclusion criteria

• 18-80 years of age, males or non-pregnant women;
• Evidence of silent ischemia, stability or in patients with old myocardial infarction or unstable angina;
• Primary target lesion, in situ coronary artery disease;
• Target lesion length ≤ 60mm, target lesion diameter 2.75mm or 4.0mm (Visual method);
• The target lesion diameter stenosis ≥ 70% (Visual method);
• Each target lesion implantation the same stent (Firehawk stand);
• With indications for coronary artery bypass surgery;
• To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

Exclusion criteria

• Within 72h of any acute myocardial infarction;
• Unprotected left main coronary artery disease, triple vessel lesions which need treated all;
• Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
• Artery and/or vein bypass graft lesions;
• Intracoronary implantation of any branding stents within 1 year;
• Severe congestive heart failure (NYHA class III and above), or left ventricular ejection fraction <35% (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.