Utilizing a Novel Agent in a Randomized Study of Accelerated Radial Arterial Hemostasis Under Reduced Compression Following Percutaneous Transradial Coronary Angiography/Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medcura Inc.
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compressive Force
研究概览
简要总结
Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage
详细描述
The study will evaluate the clinical performance (e.g. hemostatic and patient outcomes) of this hm-P bandage by using an earlier time for removal of the bandage (e.g. 60 minutes) than the current standard of care (e.g. 90-180 minutes) while also reducing the inflated pressure of the band, and hence the compressive force put on the wrist of the patient, in increments of the % of inflation as per current protocol, with N=20 @ 100%, N=20 @ 75%, & N=20 @ 50%. This study will be completed while maintaining vascular integrity and patency through visualization in patients undergoing angiographic procedures via anticoagulated, percutaneous radial arterial cannulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current patients who are undergoing diagnostic and interventional coronary/vascular angiography via a transradial approach with or without planned coronary or peripheral intervention.
排除标准
- 未提供
结局指标
主要结局
Compressive Force
时间窗: 60 minutes
Change in the compressive force onto the access site
Time to hemostasis
时间窗: 60 minutes
Significant change in time to hemostasis
次要结局
- Radial Artery(immediately after hemostasis)
