Decrease Artery Occlusion by Distal Radial Arterial Cannulation in ACS Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Forearm radical occlusion
研究概览
简要总结
The site of arterial access for coronary angiography and intervention has been the focus of research for decades as it is the source of major complications. Transradial access (TRA) reduces complications among patients undergoing percutaneous coronary procedures but is reported with the complication of radial artery occlusion (RAO) that limits the radial artery for future needs.
Distal radial access (dTRA) has recently gained global popularity as an alternative access route for vascular procedures. Among the benefits of dTRA are the low risk of entry site bleeding complications, the low rate of radial artery occlusion, and improved patient and operator comfort.
This study aims to reveal the feasibility and safety of dTRA and routine TRA procedures in acute coronary syndrome patients. The primary endpoints are forearm radical occlusion rate and major adverse cardiovascular events (MACEs) in the two groups, respectively. Investigators will also focus on puncture success in diagnostic and interventional cases, rate of One attempt success, access time, procedure time, crossover rate, contrast dose of patients, fluoroscopy time and dose, and healthcare cost of each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of a pulse in the snuffbox
排除标准
- •Absence of pulse
- •Ultrasound indication of arterial occlusion or severe calcification
- •Severe forearm artery malformation
- •Patients with severe liver and renal failure, or abnormal coagulation function
- •Established cardiogenic shock
- •History of previous coronary artery bypass grafting and radial artery use.
- •Raynaud's disease in the medical history
研究组 & 干预措施
dTRA group
Investigators perform percutaneous coronary intervention by dTRA
干预措施: distal TRA group (Procedure)
TRA group
Investigators perform percutaneous coronary intervention by conventional TRA
干预措施: conventional TRA group (Procedure)
结局指标
主要结局
Forearm radical occlusion
时间窗: during procedure
Doppler ultrasound to determine whether patients suffer forearm radial occlusion
MACEs
时间窗: during procedure
Major Adverse Cardiovascular Events, including cardiovascular death, myocardial infarction and heart failure.
次要结局
- The total cost in hospitalization(up to 2 years)
- Procedure time(during procedure)
- Contrast dose(during procedure)
- Rate of One attempt success(during procedure)
- Access time(during procedure)
- Fluoroscopy dose(during procedure)
- hand hematoma(during procedure)
- Crossover rate(during procedure)