A Randomized Study of Transradial Versus Transulnar Artery Approach for Coronary Interventions
试验速览
- 阶段
- 3 期
- 入组人数
- 572
- 试验地点
- 1
- 主要终点
- Successful arterial access free from need for crossover and free from vascular or coronary ischemic complications (MACEs)within 60± days
研究概览
简要总结
The transradial route is increasingly used as an access site in percutaneous coronary interventions, as it is considered equivalent to transfemoral approach in terms of efficacy but with a decreased vascular complication risk. Information concerning the efficacy and safety of transulnar approach is sparse. This is a prospective, randomized, investigator-initiated study to compare transradial versus transulnar approach as a default strategy for coronary angiography, ad-hoc or elective percutaneous coronary intervention (PCI). Consecutive eligible patients with an indication for coronary angiography, will be randomized after written informed consent in a 1:1 ratio to either transradial or transulnar access. Assessment of angiographic and procedural characteristics(including amount of contrast medium, arterial access, fluoroscopy and procedural time), as well as any vascular or other peri-procedural complications of the cases enrolled, will be performed. After hospital discharge, all patients will return at Day 60 ±5 days for Doppler ultrasound assessment of the forearm vessels and documentation of major adverse cardiovascular events (defined as death, myocardial infarction, target vessel revascularization and stroke. Coronary angiography patients will be additionally randomized in a 1:1 ratio to either 2500 or 5000 IU of unfractioned heparin.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •Plan for Coro- and ad hoc PCI, if necessary
- •Written informed consent
排除标准
- •Cardiogenic shock, haemodynamic instability, Killip class III
- •Chronic hemodialysis
- •Coronary artery bypass grafting (CABG) with either bilateral internal mammary artery (IMA) or bilateral radial artery use
研究组 & 干预措施
Transulnar arterial access
Transulnar arterial access for coronary angiography, ad-hoc or elective PCI
干预措施: Transulnar arterial access (Procedure)
Transradial arterial access
Transradial arterial access for coronary angiography, ad-hoc or elective PCI
干预措施: Transradial arterial access (Procedure)
结局指标
主要结局
Successful arterial access free from need for crossover and free from vascular or coronary ischemic complications (MACEs)within 60± days
时间窗: The primary end point will be assessed within 60±5 days after randomization
MACEs are considered both vascular and coronary ischemic complications. Vascular complications include arterial occlusion, local arterial perforation, compartment syndrome, pseudoaneurysm, fistula formation, major bleeding, hematoma of at least 10cm length, or any vascular damage requiring prolonged hospitalization or intervention. Coronary ishcemic complications include cardiac death, non fatal myocardial infarction, urgent repeat revascularization and stroke.
次要结局
- Fluoroscopy time(Fluoroscopy time will be assessed within 1 minute after the end of coronary angiography or coronary intervention)
- Amount of contrast medium(The amount of contrast medium will be assessed within 1 minute after the end of coronary angiography or coronary intervention)
- Vascular complication defined as post-procedural occlusion, perforation, pseudo-aneurysm, fistula or hematoma formation(Vascular complication will be assessed 6 hours after the end of coronary angiography or intervention)
- Procedural duration (defined as the sum of arterial access, coronary angiography and coronary intervention duration)(Procedural duration will be assessed within 1 minute after the end of coronary angiography or coronary intervention)