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

Not Applicable

Completed

Interventions: Device: Rapamycin target-eluting coronary stent systems (38mm)

Brief Summary: The purpose of this study is to evalute the clinical safety and effectiveness of released specification (38mm) 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 2.75mm 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.

Arm && Interventions

Group	Intervention	Description
treatment group	Rapamycin target-eluting coronary stent systems (38mm)	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems

Primary Outcome Measures

Name	Time	Method
In-stent Late Lumen Loss	9 month after stent implantation

Secondary Outcome Measures

Name	Time	Method
Participants With Target Lesion Failure	4 years after stent implantation	a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Major Adverse Cardiac Events	4 years after stent implantation	composite endpoint of all cause death, any myocardial infarction and any revascularization