Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone (SMART-CASE)
试验速览
- 阶段
- 不适用
- 入组人数
- 899
- 试验地点
- 1
- 主要终点
- A composite of all cause death, MI, or any revascularization
研究概览
简要总结
The aim of this study was to compare conservative versus aggressive strategy in patients with intermediate lesions with angiography guidance alone.
详细描述
To investigate whether conservative revascularization using criteria of 70% diameter stenosis would be non-inferior to aggressive revascularization using criteria of 50% diameter stenosis in coronary intermediate lesions, we conducted the Conservative Revascularization versus Aggressive Revascularization for Coronary Stenting with Everolimus-Eluting Stents (SMART-CASE) trial.
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
- None
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
- •Intermediate coronary lesion(s) (diameter stenosis between 50% and 70% by quantitative coronary analysis)
- •Target lesion(s) must be located in a native coronary artery with diameter of ≥2.25 mm and ≤4.25 mm
排除标准
- •cardiogenic shock
- •myocardial infarction (MI) within 48 hours
- •left main lesion
- •drug-eluting stent implantation in the target vessel prior to enrollment
- •≥2 chronic total occlusions in major coronary territories
- •history of bleeding diathesis or known coagulopathy
- •gastrointestinal or genitourinary bleeding within 3 months or major surgery within 2 months
- •platelet count <100,000 cells/mm3
- •planned elective surgical procedure that would necessitate interruption of thienopyridine during the first 6 months after enrollment
- •non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
研究组 & 干预措施
1
The aggressive group
干预措施: The aggressive group (Procedure)
2
The conservative group
干预措施: The conservative group (Procedure)
结局指标
主要结局
A composite of all cause death, MI, or any revascularization
时间窗: 1 year
次要结局
- Any revascularization(1 years)
- Target vessel failure(1 years)
- Cardiac death(1 years)
- Myocardial infarction (Q-wave and non-Q wave)(1 years)
- Stent thrombosis(1 years)
- All cause Death(1 years)
- Revascularization of target intermediate lesion(1 years)
研究者
Hyeon-Cheol Gwon
Professor
Samsung Medical Center