临床试验/NCT01266239

NCT01266239Unknown不适用

Japanese Registry Study in Comparison Between Everolimus-eluting Stent and Sirolimus-eluting Stent for the Bifurcation Lesion

Shin Yukuhashi Hospital6 个研究点分布在 1 个国家目标入组 300 人开始时间: 2010年7月1日最近更新: 2010年12月24日

适应症

试验速览

阶段: 不适用
发起方
入组人数: 300
试验地点: 6
主要终点: Major adverse cardiac events

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In study-1, the purpose of this study is to compare the long-term outcome of provisional stenting between EES and SES deployment. In study-2, it is to prove the following hypothesis " Asymmetrical expansion in the bifurcation lesion leads to frequent inhomogeneous intimal growth on the strut and thrombus attachment."

详细描述

Kissing balloon inflation brings asymmetrical expansion which may lead to a risk of disturbance of endothelialization. We will investigate the following issues.

Impact of asymmetric expansion induced by kissing balloon technique on mid and long term results
Difference between SES and EES
Impact of abnormal OCT findings on long-term clinical outcome (3yr)

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Factorial
主要目的: Treatment
盲法: None

入排标准

年龄范围: 20 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Coronary bifurcation lesion which stenotic lesion exists in the MV and / or in the side branch (SB).
•The lesion is appropriate for the provisional MV stenting.
•The reference diameter is more than 2.5mm in the MV and more than 2.0mm in the SB.

排除标准

•Left main coronary bifurcation
•Acute myocardial infarction and unstable angina which culprit vessel contains obvious thrombus
•Left ventricular ejection fraction < 30%
•Shock state
•Inappropriate candidate for the dual antiplatelet therapy, administration of contrast medium and radiation

结局指标

主要结局

Major adverse cardiac events

时间窗: 3 years

Cardiac death, myocardila infarction, target lesion revascularization, target vessel revascularization, and stent thrombosis are monitored.

次要结局

abnormal intimal coverage(9 months)

研究者

发起方

Shin Yukuhashi Hospital

申办方类型

Network

研究点 (6)

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