Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )

Not Applicable

Completed

Brief Summary: The purpose of this study is to evalute the clinical safety and effectiveness of released specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.

Recruitment & Eligibility

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 2.25mm (Visual method);
The target lesion diameter stenosis ≥ 70% (Visual method);
Each target lesion implantation the same stent (Firehawk stent);
With indications for coronary artery bypass surgery;
To understand the purpose of testing, voluntary and informed consent, patients agreed to achieve invasive imaging and clinical follow-up.

Exclusion Criteria

Within 72h of any acute myocardial infarction;
Unprotected left main coronary artery disease, triple vessel lesions which need treated all; bifurcation lesions and vascular lesions of the bridge;
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.

Arm && Interventions

Group	Intervention	Description
new specifications (Diameter 2.25mm)of Firehawk stent	FirehawkTM 2.25mm	Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease

Primary Outcome Measures

Name	Time	Method
In-stent Late Loss	9 month after stent implantation	the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With MACE	4 years	a composite endpoint of all cause death, any myocardial infarction and any revascularization
Number of Participants With Target Lesion Failure	4 years	including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization