NCT02385344已完成不适用
Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medistim ASA
- 入组人数
- 1,046
- 试验地点
- 7
- 主要终点
- Change in planned surgical procedure
研究概览
简要总结
The purpose of the registry is to collect information regarding the number and type of coronary artery bypass (CAB) surgical procedure changes that are made based on intraoperative guidance information using transit time flow measurements (TTFM) and ultrasound image capabilities provided with the Medistim device.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has been scheduled for coronary bypass surgery
- •Subject understands the nature of the procedure and has signed the subject informed consent prior to the procedure
- •Subject has been diagnosed with 2-3 vessel disease
排除标准
- •Subject is scheduled for other surgical procedures during the bypass surgery (valve replacement/repair, carotid endarterectomy, etc.)
- •Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with surgery or follow-up testing
- •Subject is undergoing an emergency cardiac bypass surgery
- •Subject has history or presence of muscle disease (i.e. myopathy, myalgia, myasthenia, rhabdomyolysis) with or without concomitant CK-elevation > 5 ULN that cannot be ascribed to any other medical condition (e.g. myocardial infarction)
- •Subject has any condition that the investigator believes should exclude him/her from this registry
结局指标
主要结局
Change in planned surgical procedure
时间窗: Day 1 (During Surgery)
Identify how often epiaortic scanning With the Medistim Device, leads to a change in the planned surgical procedure and to identify the reason and the procedure change
Procedure adaptions
时间窗: Day 1 (During surgery)
Identify the procedure adaptions made by a surgeon when TTFM and/or Medistim ultrasound imaging identify suboptimal graft function
次要结局
- Record number of revisions(Day 1 (During surgery))
- Record number of events(Day 1-14 (During hospitalization))
- Incidence rate(2 years (Throughout the study))
研究者
研究点 (7)
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