跳至主要内容
临床试验/NCT05725616
NCT05725616已完成不适用

Effectiveness of the Anatomical Snuff Box Approach for Coronary Angiography: Comparative Non-inferiority Study With the Radial Arterial Approach to the Wrist

GCS Ramsay Santé pour l'Enseignement et la Recherche2 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2023年7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
326
试验地点
2
主要终点
Success rate of coronary angiography without changing puncture route.

研究概览

简要总结

The main objective of the study is to assess whether the distal radial arterial approach (snuff box or back of the hand) is not inferior to the radial arterial approach at the wrist, in the management of coronary angiography for diagnostic purposes

详细描述

Coronary angiography is the reference examination for anatomical exploration coronary arteries to determine the presence or absence of a predominantly obstructive coronary disease.

Historically, the femoral approach was the most common approach used in interventional cardiology. The radial approach to the forearm presents multiple advantages over the femoral route, and it became the gold standard approach to coronary angiography and intervention percutaneous coronary. Although uncommon, vascular complications related to the radial pathway exist.

This is why a more distal radial approach, above the long tendon extensor of the thumb (at the level of the anatomical snuff box) or downstream (at the back of the hand) was suggested more than 10 years ago. This pathway is now an advantageous alternative to the radial approach of first intention, both for the patient and for the practitioner.

The two procedures are common today but few studies have been developed to compare the two approaches. Therefore, the main objective of the study is to assess whether the distal radial arterial approach (snuff box or back of the hand) is not inferior to the radial arterial approach at the wrist, in the management of coronary angiography for diagnostic purposes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Patient, male or female, aged 18 and over
  • Patient having a diagnostic coronary angiography programmed by radial route.
  • Patient with a radial pulse at the anatomical snuff box and at the wrist noticeable

排除标准

  • Patient requiring emergency coronary angiography or having an acute coronary syndrome
  • Patient with severe arteriopathy of the supra-aortic trunks
  • Patient with a history of coronary bypass surgery
  • Tall patients (>1.90m)
  • Patient allergic to xylocaine
  • Patient presenting a contraindication to the realization of a coronary angiography:
  • terminal IRC, pregnancy, severe sepsis....

结局指标

主要结局

Success rate of coronary angiography without changing puncture route.

时间窗: 1 day

The primary endpoint is the success rate of coronary angiography without changing puncture route.

次要结局

未报告次要终点

研究者

发起方
GCS Ramsay Santé pour l'Enseignement et la Recherche
申办方类型
Other
责任方
Sponsor

研究点 (2)

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