Comparison Study of Compression Devices Used in Transradial Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 499
- 试验地点
- 1
- 主要终点
- Radial artery occlusion
研究概览
简要总结
The transradial route is used in 90% of the coronary angiograms performed at Oslo University Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to achieve hemostasis. Patients and staff will benefit from using a device that yields safe and painless hemostasis.
Patients will be randomly assigned to receive either the standard compression device (control group, A) or a recently developed compression device (experimental group, B). The study will be designed as a non-inferiority, prospective randomized controlled trial, with outcome measures being patient comfort during compression time and complication rates. Complications that will be measured are radial artery occlusion (RAO) measured using ultrasound at a follow up visit. Hematomas or bleeds from the puncture site after application of the compression device will also be classified as complications.
The aim of the study is to investigate whether the new device, RY-STOP is non-inferior compared to the standard device, when considering the outcome measures.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing coronary angiograms via the transradial route
排除标准
- •Patients who have a long way to travel for the follow up, ultrasound scan
- •Patients that do not understand Norwegian
- •Patients presenting with acute ST segment elevation myocardial infarction (STEMI)
结局指标
主要结局
Radial artery occlusion
时间窗: 90-120 days
Subjects wil have an ultrasound scan of their radial artery preformed after their transradial coronary angiogram to see the rate of occluded arteries.
次要结局
- Device complications(1-4 hours)
- Patient experience(1-4 hours)
研究者
Anders Opdahl
MD, PhD
Oslo University Hospital