跳至主要内容
临床试验/NCT03292367
NCT03292367已完成不适用

The Procedural Success and Complication Rate of the Left Distal Radial Approach for Coronary Angiography and Percutaneous Coronary Intervention. Prospective Observational Study

Wonju Severance Christian Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年10月11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
200
试验地点
1
主要终点
Success rate of coronary angiography

研究概览

简要总结

Left distal transradial approach (ldTRA) can be an attractive alternative route for left radial and right radial artery. Recently, Ferdinand Kiemeneij reported the feasibility and safety of the use of ldTRA. But, there is few studies focused on this issue. Therefore, the purpose of this prospective observational study is to assess the feasibility and safety of the ldTRA for CAG and PCI.

详细描述

Femoral artery has been traditionally used as a standard route for coronary angiography (CAG) and percutaneous coronary intervention (PCI). Recently, the frequency of use of transradial approach (TRA) is increasing. TRA has several advantages in terms of more comfortable feeling, immediate ambulation, less bleeding complication and decreased mortality rate compared to transfemoral approach (TFA). 2015 ESC guidelines recommend to use of radial artery in order to reduce bleeding complication and mortality. But, most operators tend to prefer right radial approach (RRA) for the access route, because they are usually right-handed and feel more comfortable in the use of right radial artery. Particularly when the patient is obese or the operator's height is short or has a herniated disc on neck or waist, the discomfort may become greater.

In other hand, left radial approach (LRA) have several advantages. Left brachial artery or subclavian artery is less tortuous than right side. The manipulation of catheter is similar with femoral approach. Also, since most patients are right-handed, compression after LRA leads to greater comfort for the patient.

In comparison to the convenience of the patient and procedure, comparative studies on clinical outcomes showed similar results for both RRA and LRA. But LRA may be more at risk for radiation. This is because the operator has to lean more toward the patient for the procedure, which can result in increased radiation exposure.

Recently, the left distal radial artery approach (ldTRA) has been introduced as an alternative to feasibility and safety while satisfying both patient and operator convenience. The left palm is positioned facing the floor at the left groin. Left distal radial artery is punctured at the level of anatomical snuffbox. Ferdinand Kiemeneij reported that CAG and PCI were successfully performed in 70 patients.

There are no nerve and vein in the anatomical snuffbox. And distal radial artery is located at superficial area. So, there may be potential advantage to reduce bleeding complication and nerve injury. Moreover, ldTRA can be an alternative method for the patient requiring arteriovenous fistula and for the patient preparing coronary artery bypass graft because there is no injury of left radial artery.

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 old requiring coronary angiography
  • Patients who are palpable left distal radial artery
  • Patients who agreed to participate in the study

排除标准

  • Patients who are not palpable left distal radial artery
  • Patients who are positive in Modified Allen's test (suspicious of occlusion of ulnar artery)
  • Pregnant women
  • Patients who are not appropriate for the study

结局指标

主要结局

Success rate of coronary angiography

时间窗: 1 year

The frequency of success rate of coronary angiography (%)

Success rate of percutaneous coronary intervention

时间窗: 1 year

The frequency of success rate of percutaneous coronary intervention (%)

次要结局

  • Success rate of puncture of left distal radial artery(1 year)
  • Diameter of left distal radial artery(1 year)
  • The degree of patient's satisfaction(1 year)
  • Hemostasis duration at the puncture site(1 year)
  • Complications at the puncture site(1 year)
  • Exposure time of radiation(1 year)
  • Dose of radiation(1 year)
  • Procedure time(1 year)

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

Seung Hwan Lee

Professor

Wonju Severance Christian Hospital

研究点 (1)

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