Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures: а Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With Radial Artery Occlusion
研究概览
简要总结
This study evaluates estimate impact of introducers length during endovascular coronary procedures on rate of a radial artery occlusion. For half of participants will use short introducers, while for other will use long introducers during transradial coronary intervention.
详细描述
The transradial approach for coronary angiography and interventions is increasingly utilized around the world. Radial artery occlusion is the most common significant complication after transradial catheterization, with incidence varying between 1% and 10%. Endothelial injury of the radial artery and decrease in blood flow after sheath and catheter insertion appear to contribute to thrombus formation and are predisposing factors for radial artery occlusion. Procedural factors can predict and influence radial artery occlusion incidence. Sheath size and its relation to radial artery diameter, as well as the utilization of specific pharmacological agents (such as anticoagulants and vasodilators) have been studied. But, impact of Introducer sheath length on the rate of a radial artery occlusion has not been studied. The investigators suggest that, longer introducer sheath sizes can prevented the vascular damage and a pro-thrombotic environment.
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
- •Age over 18 years old
- •Applicability of transradial approach
排除标准
- •Failure of the transradial approach
研究组 & 干预措施
Long introducer 6Fr-25cm
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm
干预措施: Long introducer sheath (Procedure)
Short introducer 6Fr-10cm
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm
干预措施: Short introducer sheath (Procedure)
结局指标
主要结局
Number of Participants With Radial Artery Occlusion
时间窗: up to 10 days
Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.
次要结局
- Time of the Introducer Insertion(up to 10 days)
- Fluoroscopy Time(up to 10 days)
- Number of Participants With a Hematoma, Stage I(up to 10 days)
- Rate of Conversion of Needle Type(up to 10 days)
- Time of the Procedure(up to 10 days)
- Total Air Kerma(up to 10 days)
- Number of Participants With a Perforation / Dissection of a Radial Artery.(up to 10 days)
- Number of Participants With Median Nerve Neuritis(up to 10 days)
- Number of Participants With a Bleeding of the Puncture Site.(up to 10 days)