NCT02844270Unknown不适用
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
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 主要终点
- Device-related composite endpoints (Target Lesion Failure)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Device-related composite endpoints (Target Lesion Failure)
时间窗: 1 month after stent implantation
contains cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization
次要结局
- Malapposed struts percentage(6 months, 1year, 2 years and 3years)
- Late lumen loss(6 months, 1year, 2 years and 3years)
- Neointimal hyperplasia area(6 months, 1year, 2 years and 3years)
- Struts core area(6 months, 1year, 2 years and 3years)
- IVUS mean vessel area(6 months, 1year, 2 years and 3years)
- Minimal lumen diameter(6 months, 1year, 2 years and 3years)
- Procedural Success(At time of procedure up to 7 days in hospital)
- Target Lesion Failure(5 years)
- Patient Oriented Composite Endpoint(5 years)
- IVUS mean lumen area(6 months, 1year, 2 years and 3years)
- IVUS mean strut area(6 months, 1year, 2 years and 3years)
- Device Success(From the start of index procedure to end of index procedure)
- Stent Thrombosis(5 years)
- In-stent stenosis(6 months, 1year, 2 years and 3years)
- Covered struts percentage(6 months, 1year, 2 years and 3years)
- Neointimal hyperplasia area obstruction(6 months, 1year, 2 years and 3years)
- Struts neointimal thickness(6 months, 1year, 2 years and 3years)
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