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
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
- 否
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)
