Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 938
- 主要终点
- Radial artery occlusion
研究概览
简要总结
Distal radial access (dTRA) represents a novel site for radial artery access in interventional cardiology, there is little data compare dTRA with conventional radial access (cTRA) in a randomized manner.
It aims to randomly compare between the new distal radial access via the snuffbox and the conventional radial access for percutaneous coronary intervention (PCI) and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time.
Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours before and after the procedure, 4 weeks after procedure.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is over 18 years of age.
- •Patient is undergoing diagnostic coronary angiography and/or PCI for the first time.
- •Patient has provided written informed consent.
- •Patient is willing to comply with all protocol-required evaluations during the hospitalization.
排除标准
- •No palpable radial artery or distal radial artery.
- •Radial artery used as a bridging vessel.
- •Severe heart failure (NYHA class IV).
- •Severe renal insufficiency ( SCr>443umol/L).
- •Height over 185 cm.
- •A ≥7F catheter may be required for operation.
结局指标
主要结局
Radial artery occlusion
时间窗: Within 24 hours after the procedure.
Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. Incidence of radial artery occlusion as confirmed by absense of antegrade flow in vascular doppler ultrasound.
次要结局
未报告次要终点
研究者
Yujie Zhou
Doctor
Beijing Anzhen Hospital