The First-In-Man Pilot Study of Firehawk

Not Applicable

Completed

Brief Summary: This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of Microport for the first time to assess the preliminary safety and feasibility used in the human body. And provide evidence for subsequent large-scale, multi-center, randomized controlled clinical trials, then provide the basis for the formal application of the product in China.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
treatment group	Rapamycin target-eluting Coronary Stent System	Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.

Primary Outcome Measures

Name	Time	Method
Count of Participants With MACE (Major Acute Cardiovascular Events)	1 month after stent implantation	Count of Participants who have major acute cardiovascular events (MACE) in 1 month follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.

Secondary Outcome Measures

Name	Time	Method
Count of Participants With MACE (Major Acute Cardiovascular Events)	13 month after stent implantation	Count of Participants who have major acute cardiovascular events (MACE) in 13 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.
In-stent Late Lumen Loss	13 month after stent implantation	In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 13 months follow-up in-stent minimal lumen diameter.
Percentage of In-stent Diameter Stenosis	13 month after stent implantation	Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD \* 100%. RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease. MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest.