Galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System First-in-man Study

Study Overview
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Brief Summary
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The Galaxy First-in-man study is a small pilot. single arm research , which will enroll a total of 45 patients. The goal is to access the feasibility, safety and efficacy of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in the treatment of patients with de novo coronary lesion.

Detailed Description
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This study is a prospective, single arm clinical trial. 45 patients enrolled in the study will be randomly assigned to queue1 (n=30) and queue 2 (n=15). The clinical follow-up will be performed in all subjects at 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after stent implantation; angiographic,IVUS and OCT follow-up will be performed at 6 months and 2 years after stent implantation in queue 1; angiographic,IVUS and OCT follow-up will be performed at 1 year and 3 years after stent implantation in queue 2. The primary endpoint of the study is target lesion failure (TLF) at 30 days after stent implantation.

Official Title
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The Feasibility, Safety and Efficacy Evaluation of Galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System for the Treatment of Coronary Heart Disease: a First-in-man Study

Conditions
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Heart Diseases

Intervention / Treatment
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* Device: Rapamycin Drug-Eluting Bioresorbable 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 must be ≤ 25mm in length (visual estimation) and 3.0 to 3.75 mm in diameter ; Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1; The target lesion can be covered by one stent; Patient must be an acceptable candidate for coronary artery bypass graft; To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up. Exclusion Criteria: Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal; Implantation of stent in target vessel within 1 year , patients with planned intervention again within six months; 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; receiving hemodialysis; 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; To 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; The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia; Cancer need chemotherapy; Immunosuppression and autoimmune diseases, planned or undergoing immunosuppressive therapy; Planning or being receiving long-term anticoagulant therapy, such as heparin, warfarin, etc; Within six months for elective surgery requires stopping aspirin, Clopidogrel patients; Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; known or suspected liver disease (such as hepatitis); Peripheral vascular disease, 6F catheter is not available.

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: Galaxy stent<br>The galaxy Rapamycin Drug-Eluting Bioresorbable Coronary Stent System will be implanted in all subjects. | Device: Rapamycin Drug-Eluting Bioresorbable Coronary Stent System<br>* Implantation of the Rapamycin Drug-Eluting Bioresorbable Coronary Stent System<br>* Other names: Galaxy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device-related composite endpoints (Target Lesion Failure) | contains cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization | 1 month after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | Successful delivery and deployment of the assigned stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) | From the start of index procedure to end of index procedure | 
| Procedural Success | Achievement of final in-stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR. | At time of procedure up to 7 days in hospital | 
| Target Lesion Failure | Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization | 6 months | 
| Target Lesion Failure |  | 1 year | 
| Target Lesion Failure |  | 2 years | 
| Target Lesion Failure |  | 3 years | 
| Target Lesion Failure |  | 4 years | 
| Target Lesion Failure |  | 5 years | 
| Patient Oriented Composite Endpoint | Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization | 30 days | 
| Patient Oriented Composite Endpoint |  | 6 months | 
| Patient Oriented Composite Endpoint |  | 1 year | 
| Patient Oriented Composite Endpoint |  | 2 years | 
| Patient Oriented Composite Endpoint |  | 3 years | 
| Patient Oriented Composite Endpoint |  | 4 years | 
| Patient Oriented Composite Endpoint |  | 5 years | 
| Stent Thrombosis |  | 30 days | 
| Stent Thrombosis |  | 6 months | 
| Stent Thrombosis |  | 1 year | 
| Stent Thrombosis |  | 2 years | 
| Stent Thrombosis |  | 3 years | 
| Stent Thrombosis |  | 4 years | 
| Stent Thrombosis |  | 5 years | 
| Minimal lumen diameter |  | 6 months, 1year, 2 years and 3years | 
| In-stent stenosis |  | 6 months, 1year, 2 years and 3years | 
| Late lumen loss |  | 6 months, 1year, 2 years and 3years | 
| Covered struts percentage |  | 6 months, 1year, 2 years and 3years | 
| Malapposed struts percentage |  | 6 months, 1year, 2 years and 3years | 
| Neointimal hyperplasia area |  | 6 months, 1year, 2 years and 3years | 
| Neointimal hyperplasia area obstruction |  | 6 months, 1year, 2 years and 3years | 
| Struts core area |  | 6 months, 1year, 2 years and 3years | 
| Struts neointimal thickness |  | 6 months, 1year, 2 years and 3years | 
| IVUS mean vessel area |  | 6 months, 1year, 2 years and 3years | 
| IVUS mean lumen area |  | 6 months, 1year, 2 years and 3years | 
| IVUS mean strut area |  | 6 months, 1year, 2 years and 3years |