Use of Glidesheath Slender to Reduce Radial Artery Occlusion and Vascular Access Site Complications Following Transradial Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Radial artery occlusion
研究概览
简要总结
The objective of this study is to determine the rate of radial artery occlusion and vascular access site complications following transradial angiogram using a new Terumo (Tokyo, Japan) Glidesheath Slender, in comparison with the currently used 6 French (6 Fr.) radial sheath.
详细描述
Based on previously reported studies the rates of radial artery occlusion using a standard 6 Fr. sheath is around 5-10%, compared to the single feasibility study of the Glidesheath Slender by Aminian et al (see reference in the citations), the rate of radial artery occlusion was reported 0.88%.
This study will be a prospective randomized, single-blinded (patient-blinded) study, comparing the rate of radial artery occlusion and vascular access site complications between the Glidesheath Slender (Terumo, Tokyo, Japan) and the standard 6 Fr. radial sheath in patients undergoing transradial coronary catheterization.
- The study will enroll patients who will undergo elective or emergency coronary angiography and/or percutaneous coronary intervention (PCI) via transradial approach at the University of Ottawa Heart Institute.
- A baseline clinical vascular & ultrasound assessment will be performed prior to the procedure to document patency of the radial artery.
- Patients will be randomized in 1:1 fashion to either receive the Terumo Glidesheath Slender versus the currently used 6 Fr. sheath.
- The standard angiogram/ PCI will be performed as per usual practice.
- Following the angiogram, clinical vascular assessment as well as an ultrasound will be performed prior to discharge.
- At 30 days follow up the patient will come back for clinical and ultrasound assessment of radial artery patency and access site vascular complications.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing coronary angiography and/or PCI via transradial approach
- •Informed consent
- •Documented normal Allen's test
排除标准
- •Patient who had a previous angiogram using the same radial artery
- •Abnormal Allen's test
- •Previous failed radial access.
- •Known bleeding disorder or hypercoagulable condition
- •Cardiogenic shock
结局指标
主要结局
Radial artery occlusion
时间窗: 30 days
Evaluated clinically and by ultrasound
次要结局
- Vascular access site complications(up to 30 days)
- Procedure success(participants will be followed for the duration of hospital stay, an expected average of 1 day)
- Painful sheath removal(participants will be followed for the duration of hospital stay, an expected average of 1 day)
- Sheath kinking(participants will be followed for the duration of hospital stay, an expected average of 1 day)
- Radial artery spasm(participants will be followed for the duration of hospital stay, an expected average of 1 day)
研究者
Aun Yeong Chong
Interventional Cardiologist
Ottawa Heart Institute Research Corporation