Novel Angioplasty USIng Coronary Accessor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 37
- 主要终点
- Number of Patients With Radial Artery Occlusion
研究概览
简要总结
To investigate the advantage of using a 4Fr guiding catheter over a 6 Fr, frequencies of radial artery occlusion after transradial coronary intervention (TRI) will be evaluated. Radial artery occlusion rate in 4 Fr TRI group is expected to be not more than that in 6Fr groups.
详细描述
Prerequisites for TRI were a sufficiently pulsating radial artery and presence of an ulnar pulse with a sufficient palmar arch, as evidenced by the absence of digital ischemia according to the Allen's test. Exclusion criteria for the current study included planned use of a cutting balloon, rotational atherectomy, directional coronary atherectomy, and intravascular ultrasound, which were not compatible with 4-Fr catheter.
Patency of the radial artery after TRI will be evaluated by pulsation of the radial artery, and frequencies of which will be compared between those receiving 4Fr vs 6 Fr coronary interventions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prerequisites for transradial intervention were a sufficiently pulsating radial artery and presence of an ulnar pulse with a sufficient palmar arch, as evidenced by the absence of digital ischemia according to the Allen's test.
排除标准
- •Exclusion criteria included planned use of a cutting balloon, rotational atherectomy, directional coronary atherectomy, and intravascular ultrasound, which were not compatible with 4-Fr catheter.
研究组 & 干预措施
6-Fr TRI (transradial coronary intervention)
TRI will be performed using a 6-Fr guiding catheter.
干预措施: PCI (percutaneous coronary intervention) (Procedure)
4-Fr TRI
TRI will be performed using a 4-Fr guiding catheter.
干预措施: PCI (percutaneous coronary intervention) (Procedure)
结局指标
主要结局
Number of Patients With Radial Artery Occlusion
时间窗: within 2 days after TRI
The primary endpoint was radial artery occlusion the day after TRI, defined as the absence of a radial pulse confirmed by a reverse Allen's test.
次要结局
- Number of Patients With Successful PCI(within 2 days after TRI)
- Number of Patients With Access-site Complications(within 2 days after TRI)
- Number of Patients With Measure Adverse Cardiac Event (MACE)(within 2 days after TRI)
- Fluoroscopy Time Used for the Procedure(At the end of TRI)
- Contrast Dye Volume Used for the Procedure(At the end of TRI)
- Time Used for the Procedure(At the end of TRI)
- Time Used for Hemostasis(within 2 days afterTRI)
研究者
Shigeru Saito
Vice President, Shonan Kamakura Genaral Hospital
NAUSICA Investigators