The First-In-Man Pilot Study of Firehawk

Study Overview
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Brief Summary
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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.

Official Title
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The Initial Small-Scale Clinical Study of Rapamycin-Eluting Coronary Stent System of Microport (Firehawk)

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Rapamycin target-eluting Coronary Stent System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease. | Device: Rapamycin target-eluting Coronary Stent System<br>* Implantation of the rapamycin-eluting coronary stent system<br>* Other names: Firehawk;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Participants With MACE (Major Acute Cardiovascular Events) | 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. | 1 month after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent Late Lumen Loss | In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 4 months follow-up in-stent minimal lumen diameter. | 4 months after stent implantation | 
| Count of Participants With MACE (Major Acute Cardiovascular Events) | Count of Participants who have major acute cardiovascular events (MACE) in 4 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization. | 4 month after stent implantation | 
| Percentage of In-stent Diameter Stenosis | 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. | 4 months after stent implantation | 
| In-stent Late Lumen Loss | 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. | 13 month after stent implantation | 
| Count of Participants With MACE (Major Acute Cardiovascular Events) | 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. | 13 month after stent implantation | 
| Percentage of In-stent Diameter Stenosis | 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. | 13 month after stent implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sirolimus eluting stents, percutaneous coronary intervention, First in man