Comparing the Safety and Efficacy of Cordimax and Xience V Drug-eluting Stents, for the Treatment of Coronary Heart Disease (CHD) in the Clinical Research of Real World
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 3,660
- 试验地点
- 1
- 主要终点
- Target Lesion Failure(TLF)
研究概览
简要总结
Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the real world.
Study group Experimental group: Cordimax® Rapamycin Eluting Coronary Stent System Control group: XIENCE V® Everolimus Eluting Coronary Stent System
详细描述
The purpose of the post market clinical trial is to evaluate the safety and efficacy of the Cordimax Rapamycin Eluting Coronary Stent System (RECS). The Cordimax will be compared to an active control group represented by the FDA approved commercially available Abbott Vascular XIENCE V® EECS Everolimus Eluting Coronary Stent System.
The post market clinical trial consists of a randomized clinical trial (RCT) in China which will enroll approximately 3660 subjects (2:1 randomization Cordimax® RECS : XIENCE V® EECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes >= 2.5 mm and <= 4 mm.
All subjects in the RCT will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the XIENCE V® arm of US RCT.
All subjects will have clinical follow-up at 30, 60, 90days, and 1, 2, 3, 4, and 5 years so as to collect the needed data for the subsequent analysis.(Data collecting at 1st year will be conducted in the clinic in order to get the 12 lead ecg result once after out of the hospital) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •age 18 years old or more
- •patients with symptomatic coronary artery disease
- •adapt to the DES treatment according to guide
- •with one or more in diameter of the stenosis of 50% or more coronary artery lesions (refer to 2.5~4.0 mm) in diameter ;has the objective basis of myocardial ischemia
- •patients willing to participate and sign in research
排除标准
- •Women in pregnancy or lactation
- •Patients are not adapt to the antiplatelet and/or anticoagulant therapy in the expectation
- •Patients were banned to use the antiplatelet and/or anticoagulant therapy
- •Patients have participated in other devices or drugs or other research at the same time, and have not yet reached the end of the research project
- •Patients who must stop clopidogrel to accept a elective surgery
- •patients that the researchers think who are not suitable for stent placement and unable to complete the follow-up, such as the late malignant tumor patients, patients with severe liver and kidney disease, cerebral apoplexy patients, severe infection and severe patients with diseases of the blood system
研究组 & 干预措施
Cordimax
Rapamycin Eluting Coronary Stent
干预措施: Cordimax (Device)
XIENCE V
Everolimus Eluting Coronary Stent
干预措施: XIENCE V (Device)
结局指标
主要结局
Target Lesion Failure(TLF)
时间窗: at 1st year
including Cardiac death, target vessel myocardial infarction, and clinical symptom driven target vessel revascularization
次要结局
- The Success Rate of Stent Placement(in the operation)
- Thrombotic events incidence(at30 60 90 days and 1st 2st 3st 4st 5st year)
- Major adverse cardiovascular events (MACE)(at30 60 90 days and 1st 2st 3st 4st 5st year)
- Operation Success Rate(0 to 24 hours after intervention)
- Cost of the hospitalization(0 to 24hours after discharge)
- Length of stay(0 to 24 hours after discharge)