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

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Effectiveness Evaluation of New Specifications (38mm) of FirehawkTM Sirolimus Target-eluting Coronary Stent System in the Treatment of Coronary Heart Disease: a Prospective, Multicenter, Single-group Study.

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Rapamycin target-eluting coronary stent systems (38mm)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: all patients implanted Firehawk stent of new specification (38mm long)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems | Device: Rapamycin target-eluting coronary stent systems (38mm)<br> <br> * Other names: Firehawk-38;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent Late Lumen Loss |  | 9 month after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | 30 days after stent implantation | 
| Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | 6months after stent implantation | 
| Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | 12 months after stent implantation | 
| Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | 2 years after stent implantation | 
| Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | 3 years after stent implantation | 
| Participants With Target Lesion Failure | a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR) | 4 years after stent implantation | 
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 30 days after stent implantation | 
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 6 months after stent implantation | 
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 12 months after stent implantation | 
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 2 years after stent implantation | 
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 3 years after stent implantation | 
| Major Adverse Cardiac Events | composite endpoint of all cause death, any myocardial infarction and any revascularization | 4 years after stent implantation |