A Comparison of Radial Artery Clamp Times in Patients Undergoing Cardiac Catheterization Via a Percutaneous Transradial Approach
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 564
- 试验地点
- 1
- 主要终点
- Incidence of radial artery occlusion
研究概览
简要总结
The investigators will assess the effect of different times of radial clamp post procedure on radial artery occlusion and bleeding.
详细描述
The purpose of this study is to determine the safety of shorter radial artery clamp time post cardiac catheterization with respect to achieving hemostasis and the incidence of radial artery occlusion. The investigators hypothesize that shorter radial artery clamp times following cardiac catheterization will achieve similar hemostasis to longer clamp times with a decrease in the incidence of radial artery occlusion.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who require cardiac catheterization via the radial approach for the investigation and treatment of coronary artery disease.
- •Patients must have evidence of pre-procedural radial artery patency using Barbeau test.
- •Patients must be able to give informed consent
排除标准
- •Evidence of pre-procedural radial artery thrombosis
- •Inability to give informed consent
- •Patient desire not to participate in the study
- •Emergent procedures when the delay associated for obtaining informed consent may affect patient outcome
研究组 & 干预措施
Short Clamp time
Radial clamp applied at full pressure for 20 minutes. At the end of 20 minutes, the clamp will be loosened ¼ turn every 5 minutes over 20 minutes and then removed.
干预措施: Vascular compression device- RADAR TM-Short clamp time (Device)
Long Clamp Time
Radial clamp applied at full pressure for 60 minutes. At the end of 60 minutes, the clamp is to be loosened and removed under the same instruction as those patients in arm one.
干预措施: Vascular compression device RADAR TM-Long clamp time (Device)
结局指标
主要结局
Incidence of radial artery occlusion
时间窗: 24 hours
Flow assessed by pulse oximeter
次要结局
- Bleeding(24 hours)
研究者
Shahar Lavi
Interventional Cardiologist
Lawson Health Research Institute