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临床试验/NCT03389503
NCT03389503已完成不适用

Comparison Between Left and Right Transradial Approach During Coronary Angiography and Percutaneous Coronary Intervention

Wonju Severance Christian Hospital2 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2017年3月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
322
试验地点
2
主要终点
Procedural success

研究概览

简要总结

This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention.

详细描述

The three operators who are proficient in the left radial approach for coronary angiography and coronary intervention will be assigned to the right radial approach for 3 months (phase 1). After then, these three operators will switch approach site to the left radial for another 3 months (phase 2).

Procedural success, time of the procedure, use of contrast agent, and fluoroscopic data will be compared between right radial approach (phase 1) group and left radial approach (phase 2).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Other
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

入选标准

  • Subjects undergoing coronary angiography via radial approach
  • Subjects undergoing coronary intervention via radial approach
  • Subjects give written informed consent

排除标准

  • Subjects undergoing procedure(s) other than coronary angiography or intervention
  • Subjects with contraindication of radial approach (i.e, non-palpable radial pulsation, abnormal Allen's test, known radial artery tortuosity or occlusion, arteriovenous fistula for dialysis)

研究组 & 干预措施

Right radial approach

Active Comparator

Right radial approach for coronary angiography and coronary intervention

干预措施: Radial approach (Procedure)

Left radial approach

Active Comparator

Left radial approach for coronary angiography and coronary intervention

干预措施: Radial approach (Procedure)

结局指标

主要结局

Procedural success

时间窗: At the end of procedure

Finishing coronary angiography/intervention without changing approach site

次要结局

  • Puncture time(At the end of procedure)
  • Contrast amount during coronary angiography(At the end of procedure)
  • Fluoroscopic time during coronary intervention(At the end of procedure)
  • Coronary angiography time(At the end of procedure)
  • Puncture + Coronary angiography time(At the end of procedure)
  • Contrast amount during coronary intervention(At the end of procedure)
  • Coronary intervention time(At the end of procedure)
  • Fluoroscopic dose, dose area product during coronary angiography(At the end of procedure)
  • Fluoroscopic dose, dose area product during coronary intervention(At the end of procedure)
  • Fluoroscopic time during coronary angiography(At the end of procedure)

研究者

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Young Jin Youn

Assistant professor

Wonju Severance Christian Hospital

研究点 (2)

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