Surgical Measurement for Accurate Revascularization Using Transit-time FLOW (SMARTFLOW):Patency
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,242
- 试验地点
- 1
- 主要终点
- Any Graft Failure
研究概览
简要总结
The purpose of this study is to learn more about a tool called Transit-Time Flow Measurement (TTFM). TTFM uses sound waves during surgery to check how well blood is flowing through blood vessels. This helps doctors see if the blood flow is good during coronary artery bypass grafting (CABG), which is a type of heart surgery
详细描述
The SMARTFLOW:Patency trial is designed to fill this critical evidence gap by evaluating the impact of CABG graft quality assessment by TTFM on clinical outcomes in a large randomized cohort. SMARTFLOW:Patency will evaluate the impact of CABG graft quality assessment by TTFM on graft patency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •First-time, non-emergent isolated multivessel CABG through median sternotomy
- •Willing and able to provide written informed consent and comply with all study procedures, including QOL questionnaires
排除标准
- •Reoperation
- •Emergency procedures
- •Combined CABG + other cardiac or non-cardiac surgery
- •Isolated single vessel CABG
- •Minimally invasive CABG
- •Inability to undergo coronary computed tomographic angiography (CCTA)
- •Unable to provide written informed consent or comply with all the study procedures.
研究组 & 干预措施
Transit-Time Flow Measurement (TTFM)
Use of TTFM during surgery
干预措施: Transit-Time Flow Measurement (TTFM) (Device)
No Transit-Time Flow Measurement
No TTFM during surgery
结局指标
主要结局
Any Graft Failure
时间窗: 1 to 3 months after index CABG
The primary outcome of SMARTFLOW:Patency is any graft failure
次要结局
- Time to the occurrence of major adverse cardiac event (MACE)(Within 10 years of randomization)
- Time-averaged change from baseline in Seattle Angina Questionnaire.(Within 10 years of randomization)