Contemporary Chronic Total Occlusion Percutaneous Coronary Intervention Registry From Insight of Intravascular Ultrasound in Fuwai Hospital
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Target vessel revascularization
研究概览
简要总结
To evaluate the long-term outcome of chronic total occlusion (CTO) patients underwent contemporary percutaneous coronary intervention (PCI) techniques, we design this single-center, large-sample, prospective registry with five-year clinical follow-up, based on the intravascular ultrasound (IVUS) finding.
详细描述
The study plan to include the patients with a CTO lesion in one of the three main epicardial coronary artery (diameter more than 2.5 mm) as the only target lesion. The CTO lesion is defined as 0 grade of thrombolysis in myocardial infarction (TIMI) flow with evidence of occlusion duration more than 3 months. All the PCI procedure will be performed by a group of certified operators in Fuwai Hospital, Beijing, China. All patients evaluate IVUS with automatic pullback (Opticross, Boston Scientific, US) performed after wire crossing. All the included patients are planned for five-year follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female patient >18 years old
- •Thrombolysis in myocardial infarction trial (TIMI) 0 grade.
- •Evidence of occlusion period more than 3 months.
- •Patients eligible for PCI.
- •Patients eligible for coronary artery bypass graft (CABG).
- •Target vessel is one of the three main epicardial coronary arteries.
排除标准
- •Acute myocardial infarction with ongoing ST-elevation
- •Target vessel is left main or graft vessel.
- •Target vessel diameter < 2.5 mm.
- •Other situations ineligible for PCI judged in clinical practice.
- •Left ventricular ejection fraction <30%
结局指标
主要结局
Target vessel revascularization
时间窗: 5-year follow-up after index PCI
Any ischemic driven revascularization of the target vessel
次要结局
- All-cause death(Within the first 1 month after PCI and during the 5-year follow-up)
- Myocardial infarction(Within the first 1 month after PCI and during the 5-year follow-up)
- Major adverse cardiac and cerebrovascular events (MACCE)(Within the first 1 month after PCI and during the 5-year follow-up)
- Cardiac death(Within the first 1 month after PCI and during the 5-year follow-up)
- Stroke(Within the first 1 month after PCI and during the 5-year follow-up)
研究者
Lei Song, MD
Principal Investigator
China National Center for Cardiovascular Diseases