NCT01456975Unknown不适用
Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- all causes of aortic valve replacement
研究概览
简要总结
The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aortic insufficiency 2+
- •Ascending aorta size more than 5 cm
- •Ascending aorta size more than 4,5 cm (Marfan syndrome)
- •Good conditions of aortic cusps
排除标准
- •Aortic annulus more than 30 mm
- •Aortic cusps destruction
- •Critical aortic cusps elongation
- •Aortic root dissection
结局指标
主要结局
all causes of aortic valve replacement
时间窗: before discharging (average of 2 weeks after surgery)
Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed
次要结局
- all causes of death after procedure(6, 12, 24,36,48,60,72, 84, 96 months after procedure)
研究者
研究点 (2)
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