A Randomized Comparison of Clinical Outcomes Between Everolimus-eluting Bioresorbable Vascular Scaffold Versus Everolimus-eluting Metallic Stent in Long Coronary Lesions
试验速览
- 阶段
- 不适用
- 入组人数
- 950
- 试验地点
- 2
- 主要终点
- Incidence of composite of major adverse cardiovascular events
研究概览
简要总结
PCI of diffuse long coronary lesions still remains challenging because of relatively high risk of in-stent restenosis and stent thrombosis compared to short coronary lesions. The purpose of the study is to compare an incidence of composite of major adverse cardiovascular events (MACEs) at 1 year between Absorb everolimus-eluting BVS and Xience EES after coronary intervention in long lesions.
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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
absorb arm
PCI with Absorb everolimus-eluting bioresorbable vascular scaffold
干预措施: PCI with Absorb everolimus-eluting bioresorbable vascular scaffold (Device)
Xience arm
PCI with Xience everolimus-eluting metallic stent
干预措施: PCI with Xience everolimus-eluting metallic stent (Device)
结局指标
主要结局
Incidence of composite of major adverse cardiovascular events
时间窗: 1 year after PCI
Cardiac death, nonfatal myocardial infarction (MI), stent thrombosis and target-lesion revascularization (TLR)
次要结局
未报告次要终点