Radial Artery Puncture Hemostasis: Physical, Biological and Chemical Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- Radial artery fistula formation
研究概览
简要总结
RAPHE is an open label randomized clinical trial to assess physical, biological and chemical methods of radial artery puncture hemostasis following coronary catheterization.
A total of 600 subjects will be randomized in a 1:1:1 fashion to either the StatSeal, Axiostat or TR Band hemostasis devices.
Follow-up of the subject will take place 60 days after the index procedure.
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
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary angiogram planned from a radial artery approach
- •Use of 5, 6 or 7 French sheaths
排除标准
- •Radial artery diameter <1.8 mm as measured via ultrasound
- •Established peripheral arterial disease
- •Known autoimmune illness
- •Hemodynamic instability
- •Pregnant or nursing
- •Condition following resuscitation
结局指标
主要结局
Radial artery fistula formation
时间窗: 60 days (+/-10 days) post-procedure
Frequency of radial artery arteriovenous fistula formation after hemostasis
Radial artery bleeding
时间窗: 60 days (+/-10 days) post-procedure
Bleeding from the radial artery puncture, classified via the EASY method
Radial artery (pseudo)aneurysm formation
时间窗: 60 days (+/-10 days) post-procedure
Frequency of radial artery (pseudo)aneurysm formation after hemostasis
Radial artery occlusion
时间窗: 60 days (+/-10 days) post-procedure
Frequency of radial artery occlusion after hemostasis
次要结局
- Overall compression time(Up to 24 hours post-procedure)
- Initial compression time of hemostatsis device(Up to 30 minutes post-procedure)
- Number of compression devices needed(Up to 24 hours post-procedure)
研究者
Istvan Edes
Associate Professor
Semmelweis University Heart and Vascular Center