NCT02375542已完成不适用
Clinical Observation and Pathological Characterization of Aortic Tissue at Reoperation
CryoLife Europa1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2015年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- The microscopic evaluation of the presence of BioGlue on aortic tissue
研究概览
简要总结
This study will analyse factors contributing to cardiac re-operation to determine causative effects
详细描述
This study will collect clinical data on the characteristics of aortic tissue on which BioGlue has been applied during a previous cardiovascular surgery. This is a post market surveillance study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing an aortic re-operation
- •Subject has had BioGlue used during previous aortic surgery
- •Subject is willing and able to give written informed consent for participation
排除标准
- •Subject with a history of vasculitis
- •Subject with active infection (endocarditis)
- •Subject with a history of chronic inflammatory condition which may have led to ongoing tissue damage
- •Subject with a history of auto immune disease
结局指标
主要结局
The microscopic evaluation of the presence of BioGlue on aortic tissue
时间窗: "participants will be followed for the duration of their surgery, an expected average of 5 hours
次要结局
- Observation and characterization of BioGlue usage during the reoperation procedure("participants will be followed for the duration of their surgery, an expected average of 5 hours)
研究者
研究点 (1)
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