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临床试验/NCT02034084
NCT02034084已完成不适用

A Comparison of Left and Right Radial Approach for Percutaneous Coronary Procedures

Capital Medical University2 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,400
试验地点
2
主要终点
Total procedural duration

研究概览

简要总结

Previous studies have shown that the transradial cardiac catheterization has decreased not only bleeding complications related to the access site and procedural discomfort but also morbidity and hospitalization as compared to transfemoral approach. At present, the right radial approach (RRA) is the first choice routinely for coronary angiography and interventions in daily clinical practice despite more marked subclavian artery tortuosity than left radial approach (LRA). Although LRA has been thought to be more direct access to the ascending aorta similar to transfemoral approach and may reduce fluoroscopy time and cerebrovascular complications compared with RRA, the application of LRA for coronary intervention is still low. Moreover, several studies have also obtained conflicting results showing no difference in procedural success rate compared LRA and RRA using Judkins catheters. To date, it remains unclear whether LRA is superior to RRA in term of safety and feasibility for coronary angiography and interventions in real world practice and few data of randomized control trial are available.

The aim of this study was to randomly investigate and compare the safety and feasibility of LRA compared with RRA for coronary diagnostic angiography in Chinese subjects.

The investigators will enroll consecutively for 2 years all patients undergoing coronary diagnostic procedures through trans radial approach.

The primary outcome was total procedural duration. Secondary outcomes included fluoroscopy time, dose of radiation including cumulative air kerma and dose area product, contrast volume and the incidence of 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
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All consecutive patients who undergo to diagnostic coronary procedures

排除标准

  • Acute ST-elevation myocardial infarction
  • Previous coronary artery bypass graft surgery
  • Hemodynamic instability

结局指标

主要结局

Total procedural duration

时间窗: 1 day

次要结局

  • Contrast volume(7 days)
  • Dose of radiation(7 days)
  • Fluoroscopy time(7 days)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Buxing Chen

Director of department of cardiology

Capital Medical University

研究点 (2)

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