跳至主要内容
临床试验/NCT04861389
NCT04861389Unknown不适用

The Comparison of Distal Transradial Access and Transradial Access for Primary Percutaneous Coronary Intervention in STEMI Patients(RESERVE Trial) A Single-center, Open, Prospective, Randomized Controlled Trial

Shenzhen People's Hospital1 个研究点 分布在 1 个国家目标入组 414 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
414
试验地点
1
主要终点
The RAO incidence during hospitalization

研究概览

简要总结

The transradial access (TRA) is currently the preferred approach for percutaneous coronary intervention (PCI). However, in patients with ACUTE ST-segment elevation myocardial infarction (STEMI) after emergency PCI, the high incidence of THE radial artery RAO limits the future choice of the radial artery for percutaneous intervention. The literature reported that distal transradial access (dTRA) significantly reduced RAO after elective PCI, but the application of dTRA in emergency PCI in STEMI has not been reported. We have completed 126 cases of dTRA undergoing emergency PCI after STEMI, which has been preliminarily confirmed to be safe and effective. A single-center, open, prospective, randomized controlled study is planned to compare the use of dTRA and TRA in emergency PCI in STEMI patients. The primary endpoint was the INCIDENCE of RAO within 24 hours after surgery. This clinical study verified that dTRA compared with TRA could reduce the RAO incidence of STEMI patients after emergency PCI. The project will explore a new artery approach to reduce RAO, and provide a basis for the selection of artery approach in STEMI emergency PCI patients.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of STEMI
  • To undergo emergency PCI treatment
  • Palpable pulsation of the radial artery and distal radial artery

排除标准

  • Arteriovenous fistula of radial artery and cephalic vein has been performed with regular hemodialysis
  • Suspicious left main block of electrocardiogram
  • Had used the radial artery percutaneous interventional treatment before
  • Cardiogenic shock

结局指标

主要结局

The RAO incidence during hospitalization

时间窗: 7 days

The incidence of radial artery occlusion during hospitalization

次要结局

  • Puncture time(During the intervention)
  • Incidence of hematoma, finger numbness or pain during hospitalization(7days)
  • Compression time(4-24 hours)
  • Incidence of RAO at 1 and 6 months after surgery(1 and 6 months)
  • Puncture success rate(During the intervention)

研究者

发起方
Shenzhen People's Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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