Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With ST-elevation Myocardial Infraction (STEMI): The DR-STEMI Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 554
- 试验地点
- 6
- 主要终点
- needle-to-wire time
研究概览
简要总结
Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed for undertaking percutaneous coronary angiography and interventions. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.
详细描述
Gaining vascular access is the first, mandatory step for undertaking percutaneous coronary angiography and interventions. The recent guidelines, published by European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI), propose TRA as the gold standard for acute coronary syndromes (ACS), chronic coronary syndrome (CCS) percutaneous coronary interventions (PCI). Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Mutual point of all the previous RCTs is that excluded patients suffering from ST-elevation Myocardial Infraction (STEMI). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 old
- •Indication: ST-Elevation Myocardial Infraction
排除标准
- •Non-palpable radial artery
- •Previous CABG
- •Anatomical restrictions for forearm approach
- •Hemodynamic instability
- •Previous radial artery catheterization from the same arm during the last 30-days
研究组 & 干预措施
Distal transradial artery access
Vascular access after cannulation of distal transradial artery through anatomical snuffbox for coronary angiography and interventions
干预措施: Coronary angiography +/- percutaneous coronary intervention (Procedure)
Conventional transradial artery access
Vascular access after puncturing on the conventional transradial artery for performing coronary angiography and interventions
干预措施: Coronary angiography +/- percutaneous coronary intervention (Procedure)
结局指标
主要结局
needle-to-wire time
时间窗: Immediately post-procedurally
needle-to-wire time
次要结局
- Required time percutaneous coronary intervention completion(Immediately post-procedurally)
- Access site crossover rate(Immediately post-procedurally)
- Required time for coronary angiography completion, after sheath insertion(Immediately post-procedurally)
- Air Kerma(Immediately post-procedurally)
- Vascular complications(24 hours)
- 30-days Clinical follow-up (on site or via telephone call)(30 days)
- Radial artery occlusion using Doppler examination prior to hospital discharge(The evaluation will be performed during hospitalization for STEMI and prior discharge, typically the 4th day after PCI)
- Sheath insertion time(Immediately post-procedurally)
- Total procedure time(Immediately post-procedurally)
- The time interval between the initiation of radial artery puncture and the completion of coronary angiography, until the beginning of the possible PCI(Immediately post-procedurally)
- Total fluoroscopy time(Immediately post-procedurally)
- Total Dose Area Product (DAP)(Immediately post-procedurally)
- Hemostasis time(3 hours)
- Hematomas classification (modified EASY classification)(24 hours)
研究者
Grigorios Tsigkas
Assistant Professor of Cardiology
University Hospital of Patras