跳至主要内容
临床试验/NCT05702060
NCT05702060已完成不适用

Comparison of raDiatiOn Exposure to Operators in Coronary Angiography and Percutaneous Coronary Intervention Between Right Conventional and Left Distal Radial artEry Approach: Multicenter, Randomized Study

Yonsei University6 个研究点 分布在 1 个国家目标入组 1,010 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
已完成
入组人数
1,010
试验地点
6
主要终点
Radiation exposure examination

研究概览

简要总结

The purpose of this study is to show that the radiation exposure of the left distal radial artery approach is superior to the conventional right radial artery approach in terms of less radiation exposure.

详细描述

The conventional radial approach is now recognized as the basic technique in coronary artery surgery. Compared to the femoral artery access, the main advantage is the increased stability due to the reduction of massive bleeding. Due to these advantages, recent guidelines recommend the conventional radial approach as the basic approach for all acute myocardial infarction (AMI) cases with or without ST-segment elevation. In particular, in the case of ST-segment elevation myocardial infarction (STEMI), new antiplatelet agents such as Ticagrelor and Prasugrel and strong antiplatelet agents such as Glycoprotein inhibitors have been used to prevent major vascular complications. For these many operators, primary percutaneous coronary intervention (PCI) through the radial artery is recommended. At this time, the operator prefers the right radial artery approach because of the comfort of performing the procedure on the patient's right side. However, the operator sometimes has to substitute the left radial artery or femoral artery access due to difficulty in manipulating the catheter due to severe tortuousness of the right subclavian artery. Although the left radial artery approach requires less operation time and radiographic imaging time due to less tortuousness of the left subclavian artery, the right conventional radial approach is still preferred due to the ergonomic inconvenience of having to lean toward the patient. Patients undergoing coronary angiography (CAG) were randomly assigned to the left snuffbox approach and the right conventional radial approach, and the surgeons' radiation exposure between the two approaches was evaluated and compared.

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

入选标准

  • Patients aged 20 years or older
  • Patients scheduled for coronary angiography and intervention

排除标准

  • When the pulse of the Left distal radial artery cannot be palpated
  • When the pulse of the right conventional radial artery cannot be palpated
  • In case of arteriovenous fistula
  • Acute myocardial infarction (AMI) patients
  • In case femoral artery access must be performed (state of shock, etc.)
  • In case of atrioventricular block
  • When an ergonovine provocation test is required
  • When the patient refuses to consent to the study
  • a pregnant or nursing woman

结局指标

主要结局

Radiation exposure examination

时间窗: Through procedure completion, up to 24 hours

Radiation exposure for surgeons in the case of the left distal radial artery approach and the right radial artery approach, respectively

次要结局

  • Amount of contrast agent used(Through procedure completion, up to 24 hours)
  • Fluoroscopy time(Through procedure completion, up to 24 hours)
  • Corrected by X-ray dose Radiation exposure of surgeons(Through procedure completion, up to 24 hours)
  • Procedure success rate(Through procedure completion, up to 24 hours)
  • Corrected by X-ray dose Radiation(Through procedure completion, up to 24 hours)
  • Hemostasis time(Through procedure completion, up to 24 hours)

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 (6)

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