Randomized Comparison f Dual Artery Compression Versus Radial Artery-Only Hemostasis: Impact on Radial Artery Occlusion (EArly Discharge After Transradial Stenting of coronarY Arteries - EASY-RAO)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of RAO after transradial approach (TRA) at hospital discharge
研究概览
简要总结
This study aims to demonstrate the superiority in clinical performances of a dual artery compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device (HemoSTOP).
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
- 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
- 否
入选标准
- •any patients referred for diagnostic angiography and possible percutaneous coronary intervention (PCI)
排除标准
- •Patient unable to understand study design or objectives
- •Unable to sign informed consent
- •Patient taking warfarin or other anticoagulant therapy
- •Chronic RAO on both sides precluding TRA
- •Previous ipsilateral transradial approach
- •Inability to comply with the study follow-up
- •Presence of plethysmographic waveform with radial and ulnar occlusive compression
- •Pre-existing local complication (i.e. hematoma, pseudo-aneurysm, ...) precluding access-site evaluation.
研究组 & 干预措施
Dual Artery Compression
time to hemostasis and incidence of radial artery occlusion will be monitored while using a dual artery compression device (Terry-2-band) to achieve hemostasis.
干预措施: Hemostasis (Device)
Radial Artery-Only
time to hemostasis and incidence of radial artery occlusion will be monitored while using the device currently approved by the institution (Hemo-Stop) and following institutional protocols for hemostasis.
干预措施: Hemostasis (Device)
结局指标
主要结局
Rate of RAO after transradial approach (TRA) at hospital discharge
时间窗: up to 24 hours
To determine whether the use of a dual artery compression decreases the rate of radial artery occlusion after transradial catheterization.
次要结局
- Percentage of radial artery patent-hemostasis during hemostasis(throughout intervention, up to 180 minutes)
- Patient comfort during hemostasis as assessed on a visual scale(throughout intervention, up to 30 days)
- Rates of complications such as repeat bleeding and hematoma (EASY Scale)(throughout intervention, up to 30 days)
- Nursing involvement in hemostasis management for sensitivity analysis on cost assessment(throughout intervention, up to 24 hours)
研究者
Olivier F. Bertrand
Director of the International Chair on Interventional Cardiology and Transradial Approach
Laval University