NCT01046409Unknown不适用
Comparison of Clinical, Electrical and Physiologic Significance Between Main Branch and Side Branch Vessels
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- ST elevation during 1min balloon occlusion
研究概览
简要总结
The purpose of this trial is
- to compare the clinical significance of the main vessel and the side branch vessel using EKG, pain score and coronary wedge pressure
- to develop a new scoring system to predict the clinical significance of a side branch
详细描述
- Clinical significance EKG change, pain score during 1 min balloon occlusion
- Different characteristics between ST segment elevation vs non-elevation side branches
- Comparison of coronary wedge pressure
- Establishing a new scoring system to predict the ST elevation during 1min balloon occlusion
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to verbally confirm understandings of risks, benefits of receiving percutaneous coronary intervention (PCI) for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
- •Significant stenosis at bifurcation lesion (>50% by visual estimate) which always includes stenosis of side branch (true bifurcation)
- •Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) in a native coronary artery with diameter of ≥ 2.25 mm
- •Target lesion(s) amenable for PCI with final kissing balloon angioplasty for the side branch
排除标准
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- •Patients refuse to give informed consent
- •Patients with left main coronary artery stenosis
- •Patients with total occlusion of the bifurcation lesion
- •Patients with infarct-related artery at the lesion of interest
- •Patients with left ventricular ejection fraction<40%
- •Patients with primary cardiomyopathy
- •Patients with chronic kidney disease defined as serum Cr>2.0
- •Patients who have severe side effects or contraindication to adenosine
结局指标
主要结局
ST elevation during 1min balloon occlusion
时间窗: Day 1 after PCI
次要结局
- Pain score during 1min balloon occlusion(Day 1 after PCI)
- coronary wedge pressure(during the procedure)
- Usefulness of new scoring system(During the procedure)
研究者
Bon-Kwon Koo
Associate professor
Seoul National University Hospital
研究点 (1)
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