Effect of Ultimaster Stents Treated to the Most Dilated Coronary Vessels
Prospective, Open, Randomized Study Comparing the Effects of Ultimaster® Stents Treated With Conventional Methods on Coronary Artery Lesions Compared to the Most Dilated Coronary Vessels
In patients with vasospasm or with negative remodeling, various vasodilator drugs used during coronary angiography can dilate the diameter of the reference vessel to measure the exact vessel size. In particular, nitrates are well known to induce pharmacological vasodilatory effects through vascular smooth muscle relaxation In actual clinical practice, it has been reported that when oral or spray-type nitrate preparations are administered to coronary artery stenosis lesions, the diameter of the reference vessel expands by about 10% compared to the existing vessel diameter. This may enable larger stenting in coronary artery stenosis lesions. Although many patients with vascular stenosis are accompanied by vasospasm and voice remodeling, in actual clinical practice, administration of vasodilators is only used in a small number of patients at the discretion of the surgeon. Nitrate vasodilators administered during coronary angiography are low-dose and short-acting drugs, and although a small number of patients may experience side effects such as short-term lowering of blood pressure, no serious side effects are reported .
On this background, this study is to evaluate whether there is a difference in the diameter of the Ultimaster® stent treated with the conventional method compared to the maximally dilated coronary artery, and to evaluate the stability and effectiveness after the procedure.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Sang-Don Park, Ph.D
- 电话号码:821033356991
- 邮箱:denki1@inha.ac.kr
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Over 19 years old
evidence of coronary artery disease including asymptomatic ischemia stable angina acute coronary syndrome (unstable angina, non-ST segment elevation
- myocardial infarction, ST segment elevation myocardial infarction).
- coronary artery diameter 2.25~3.5mm, stenosis 50% or more
- Those who voluntarily agreed in writing to participate in this clinical study
Exclusion Criteria:
- instability or psychogenic shock within 24 hours before percutaneous coronary intervention
- life expectancy no longer than 1 year
- hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel
- patients whom researchers think unsuitable for participation in this study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Nitrate Group
with administration of intra-coronary nitrate before percutaneous coronary intervention
|
Administration of intra-coronary nitrate before percutaneous coronary intervention
其他名称:
|
安慰剂比较:Control Group
without administration of intra-coronary nitrate before percutaneous coronary intervention
|
Administration of intra-coronary nitrate before percutaneous coronary intervention
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Mean stent diameter
大体时间:Immediately after percutaneous coronary intervention
|
Immediately after percutaneous coronary intervention
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Failure rate of target lesion for 1-year (combination of cardiac death, target vascular myocardial infarction, target vascular revascularization)
大体时间:1 year after percutaneous coronary intervention
|
1 year after percutaneous coronary intervention
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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