Distal Radial Access for Primary Percutaneous Coronary Intervention in STEMI Patients to Prevent Acute Radial Artery Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 512
- 试验地点
- 1
- 主要终点
- radial artery occlusion
研究概览
简要总结
Randomized-controlled trial to compare early radial artery occlusion via distal vs. conventional transradial access among ST segment elevation myocardial infarction patients for primary percutaneous coronary intervention.
详细描述
Conventional transradial access (TRA) is recommended as the default approach for patients undergoing percutaneous coronary intervention (PCI) according to 2018 ESC guidelines. However, radial artery occlusion (RAO) remains the frequent complication, precluding the future use of the radial artery as an access point for repeat coronary recanalization or as a conduit for coronary artery bypass surgery. More than 50% of patients with ST segment elevation myocardial infarction (STEMI) present multiple vascular lesions, of which 50% require reprocessing non-culprit vessels. Therefore, the patency of the radial artery is crucial for STEMI patients. The distal radial access (DRA), located in the anatomical snuffbox or the dorsum of the hand, was introduced as a promising alternative. Three recent RCTs have shown significant reductions of RAO after DRA compared with TRA. Nevertheless, all of them excluded the patients presenting with STEMI. Therefore, we conduct a prospective, single-center, open-label randomized clinical trial to assess the superiority of preventing RAO at 24 h via DRA when compared TRA among STEMI patients for primary PCI.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •ST-segment elevation myocardial infarction for primary percuteous coronary intervention
- •Palpable pulses on both access sites of the radial artery
- •Informed consent
排除标准
- •Thrombolysis before primary percutaneous coronary intervention
- •Previous CABG or radio-cephalic fistula using radial artery
- •Cardiogenic shock
- •Severe arrhythmias
- •Severe liver and kidney dysfunction
- •Pregnancy
- •Enrolment in another study within 1 month
- •Inability to obtain written informed consent
结局指标
主要结局
radial artery occlusion
时间窗: at 24 hours after procedure
The radial artery occlusion will be evaluated 24 hours after procedure by ultrasound.
次要结局
- the rate of successful puncture(Immediately post-procedurally)
- radial aretry injury(Immediately post-procedurally)
- major adverse cardiovascular events(MACE)(30 days after procedure)
- puncture time(Immediately post-procedurally)
- first medical contact to device (FMC2D) time(Immediately post-procedurally)
- hand function(1 week after procedure)
- access-related complications(at 24 hours after procedure)
- hemostasis time(at 24 hours after procedure)
- radial artery occlusion(30days after procedure)
- procedural time(Immediately post-procedurally)
