NCT01574586Unknown不适用
A Multicenter, Randomized Trial to Compare 2 Link Nobori and 3 Link Xience Stents in Bifurcation Stenting
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Minimum lumen diameter of the side branch ostium in bifurcation
研究概览
简要总结
The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience) in patients with de novo true bifurcation lesions.
The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE rate until one year after PCI will be assessed in both groups.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient eligible for percutaneous coronary intervention
- •Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence
- •De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%)
- •Second vessel at coronary bifurcation treatable with trial device during the procedure
- •True coronary bifurcation, ≥50% diameter stenosis in both the main and side branches, belonging to the Medina classes 1.1.1, 1.0.1, and 0.1.1,
- •Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, ≥2.25 mm in the side branch
- •Target lesion treatable with one or two stents in both the main and side branches
- •Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery
- •Thrombolysis in Myocardial Infarction grade ≥1 flow in both the main and side branches
排除标准
- •A. General restrictions
- •Unable to be followed by the implementing medial institution
- •Life expectancy <1 year
- •Acute myocardial infarction (<1 week)
- •Left ventricular ejection fraction <30%
- •Scheduled for elective treatment requiring antiplatelet drug Withdrawal
- •Deemed as unsuitable by the investigator or subinvestigator
- •Serum creatinine level ≥2.0 Mg/dl
- •B. Vascular morphological restrictions
- •Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation ≤5.0 mm) or including a part of coronary artery bypass grafting
- •In-stent restenosis
- •Severe calcification
结局指标
主要结局
Minimum lumen diameter of the side branch ostium in bifurcation
时间窗: 8 months
次要结局
- Incidence of MACE(in-hospital, 30 days, 8 months, 1 year)
研究者
研究点 (2)
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