KCT0002900已完成未知
A randomized comparison of clinical outcomes between everolimus-eluting bioresorbable vascular scaffold versus everolimus-eluting metallic stent in long coronary lesions
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 341
研究概览
简要总结
At 12 months, the primary endpoint events occurred in 2 patients (1.2%) in the BVS group and in 4 patients (2.4%) in the EES group (hazard ratio [HR]=0.49, 95% confidence interval [CI]=0.09-2.67, P=0.398).
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •Age 19-85 years
- •Patients with ischemic heart disease requiring PCI
- •Significant coronary de novo lesion (stenosis >50% by quantitative angiographic analysis) requiring stent =28 mm in length based on angiographic estimation
- •Reference vessel diameter of 2.5 to 3.75 mm by operator assessment
排除标准
- •Acute myocardial infarction within 48 hours with unstable hemodynamics requiring pharmacologic or mechanical support
- •Complex coronary morphology including left main disease and bifurcation lesion requiring two-stent technique
- •Contraindication or hypersensitivity to anti-platelet agents or contrast media
- •Treated with any metallic stent or BVS within 3 months at other vessel
- •Cardiogenic shock
- •Left ventricular ejection fraction <40%
- •Pregnant women or women with potential childbearing
- •Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- •Inability to understand or read the informed content
研究者
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