NCT03537118已完成不适用
Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures: a Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 621
- 试验地点
- 2
- 主要终点
- Incidence of major vascular complications
研究概览
简要总结
A randomized, controlled trial to determine whether the use of ultrasound guidance for vascular access during coronary angiography or percutaneous coronary intervention (PCI) will reduce the rates of major vascular complications.
详细描述
Patients who will undergo a coronary angiography or PCI using femoral access will be allocated to either: 1) femoral access using fluoroscopic and ultrasound guidance, or 2) femoral access using fluoroscopic guidance alone.
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
- Double (Participant, 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
- •Patient referred for coronary angiography or percutaneous coronary intervention (PCI) in whom femoral access is planned.
- •Planned femoral access
排除标准
- •Age ≤ 18 years
- •Absence of palpable femoral pulse
结局指标
主要结局
Incidence of major vascular complications
时间窗: up to 30 days post-procedure
Femoral artery pseudoaneurysm, AV fistula, retroperitoneal bleed, large hematoma (\>5 cm), ischemic limb requiring intervention or surgery, or major bleed based on BARC II, III, or V criteria
次要结局
未报告次要终点
研究者
研究点 (2)
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