跳至主要内容
临床试验/NCT05776550
NCT05776550进行中(未招募)不适用

A Prospective Registry to Assess the Safety and Efficacy of Distal Radial Access (SAFE-BOX)

Yonsei University2 个研究点 分布在 1 个国家目标入组 3,600 人开始时间: 2023年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
3,600
试验地点
2
主要终点
Success rate of examination and procedure

研究概览

简要总结

A Prospective Registry to assess the Safety and Efficacy of Distal Radial Approach

详细描述

Anaphylactic radial approach is now recognized as a basic technique in coronary artery procedures. The main advantage is increased stability due to the reduction of massive bleeding and increased patient comfort because it can move immediately after the procedure. The operator prefers access to the right radial artery because of the comfort of performing the procedure on the right side of the patient. However, the operator should frequently replace it with a left radial artery approach for various reasons, including 1) closure of the right radial artery, 2) difficulty accessing the coronary artery due to severe gambling of the radial artery, and 3) hemodialysis of the right radial artery.

As for prognosis, the left and right radial artery approaches are similar. However, the left radial artery approach is bound to experience anthropological discomfort in which the operator has to lean toward the patient. An easy solution is the approach from the anatomical left snuff box located on the back of the hand to the distal radial artery. Recently, the left snuffbox approach has been reported, and attempts are increasing in many countries. However, it is true that there is still a difference in diameter of the radial artery through the distant radial artery approach and concerns about percutaneous coronary intervention through this compared to the classical radial artery approach. Recent studies have published studies on the stability and effectiveness of distant radial artery approaches, but they are still small, and studies on specific subgroups are very scarce. Furthermore, data on the current status and performance in Korea so far is very scarce. Therefore, through this study, we would like to systematically collect and analyze data on the status and performance of the approach through the distant radial artery approach to find out the stability and effectiveness of various patient groups, treatment methods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients over 20 years of age
  • Patients requiring coronary angiography or intervention
  • Patients with palpable distant radial artery

排除标准

  • Patients with distant radial artery too small or not palpable
  • Pregnant women
  • Patients not appropriate for the researcher to judge

结局指标

主要结局

Success rate of examination and procedure

时间窗: through procedure completion, up to 24 hours

Success rate of examination and procedure

次要结局

  • the success rate of the puncture(through procedure completion, up to 24 hours)
  • puncture time(through procedure completion, up to 24 hours)
  • complications of the puncture region(the first outpatient visit after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yongcheol Kim

Clinical Associate Professor

Yonsei University

研究点 (2)

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