NCT02688868已完成不适用
The Safety and Effectiveness Evaluation of New Specifications (2.25mm) of FirehawkTM Sirolimus Target-eluting Coronary Stent System in the Treatment of Coronary Heart Disease: a Prospective, Multicenter, Single-group Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- In-stent Late Loss
研究概览
简要总结
The purpose of this study is to evalute the clinical safety and effectiveness of released specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 2.25mm (Visual method);
- •The target lesion diameter stenosis ≥ 70% (Visual method);
- •Each target lesion implantation the same stent (Firehawk stent);
- •With indications for coronary artery bypass surgery;
- •To understand the purpose of testing, voluntary and informed consent, patients agreed to achieve invasive imaging and clinical follow-up.
排除标准
- •Within 72h of any acute myocardial infarction;
- •Unprotected left main coronary artery disease, triple vessel lesions which need treated all; bifurcation lesions and vascular lesions of the bridge;
- •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.
结局指标
主要结局
In-stent Late Loss
时间窗: 9 month after stent implantation
the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.
次要结局
- Number of Participants With MACE(4 years)
- Number of Participants With Target Lesion Failure(4 years)
研究者
研究点 (1)
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