NCT02269449Unknown不适用
RAP and BEAT Clinical Trial (Radial Artery Patency and Bleeding, Effectiveness, Adverse evenT Trial)
NPO International TRI Network0 个研究点目标入组 1,900 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,900
- 主要终点
- Radial artery occlusion
研究概览
简要总结
The objectives of this study are to demonstrate the safety and efficacy of the new 6Fr sheath (Glidesheath slender; Terumo, Tokyo,Japan ; GSS) compared with the contemporary 5Fr sheath (Hydrophilic coating sheath from Terumo; Tokyo, Japan (standard of care ; SOC).
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
- Single (Participant)
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
- •Patient is able to verbally acknowledge an understanding of the associated risks, benefits and treatment alternatives and he or his legally authorized representative provides written informed consent prior to the randomization, as approved by the appropriate IRB.
- •Patient who is expected to diagnose by coronary artery angiography or followed by PCI.
- •Patient must agree to undergo all protocol-required follow-up examinations.
- •Patient who can accept radial access.
排除标准
- •Patient has other medical illness (e.g., cancer or congestive heart failure) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- •Hemodialysis patient
结局指标
主要结局
Radial artery occlusion
时间窗: Day 1
Local bleeding from puncture site
时间窗: Day 1
次要结局
- Vascular access site complication(Day 1)
- Procedure success rate(Day 1)
- Radial spasm during the index procedure(Day 1)
- Total Procedure Time(Day 1)
- Pain score(Day 1)
- Total Radiation Doses(Day 1)
- Device failure for the assigned sheath introducer(Day 1)
- Total Amount of Contrast Dye(Day 1)
研究者
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