Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access SIte Complication Reduction in Cardiac Catheterization (REBIRTH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,266
- 试验地点
- 12
- 主要终点
- Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)
研究概览
简要总结
This is a phase IV, prospective, open label, randomized-controlled study that will compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion.
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
- 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 and older
- •Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI
- •Has provided informed consent and agrees to participate
- •Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access
排除标准
- •Primary PCI for STEMI
- •Planned right heart catheterization
- •Valvular heart disease requiring valve surgery within 30 days after the index procedure
- •Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one)
- •Peripheral arterial disease prohibiting vascular access
- •Presence of bilateral internal mammary artery coronary bypass grafts
- •International normalized ratio ≥1.5 while treated with oral vitamin K antagonists (i.e. warfarin) Receipt of oral factor Xa or IIa inhibitors ≤24 h before procedure
- •Planned staged PCI within 30 days after index procedure.
- •Any planned surgeries within 30 days after index procedure
- •Planned dual arterial access (for example for chronic total occlusion PCI)
- •Coexisting conditions that limit life expectancy to less than 30 days
- •Positive pregnancy test
研究组 & 干预措施
Radial access
Radial access for cardiac catheterization. Radial access will be performed using ultrasound guidance and a micropuncture needle or catheter-over-needle system, as per the local standard of care.
干预措施: Radial Access (Procedure)
State-of-the-art femoral access
Femoral access for cardiac catheterization. Femoral access will be obtained using state-of-the-art techniques (ultrasound and fluoroscopic guidance for arterial puncture, immediate femoral angiography after obtaining access and use of a vascular closure device whenever possible).
干预措施: State-of-the-art femoral access with 18 gauge needle (Procedure)
State-of-the-art femoral access
Femoral access for cardiac catheterization. Femoral access will be obtained using state-of-the-art techniques (ultrasound and fluoroscopic guidance for arterial puncture, immediate femoral angiography after obtaining access and use of a vascular closure device whenever possible).
干预措施: State-of-the-art femoral access with 21 gauge needle (Procedure)
结局指标
主要结局
Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)
时间窗: Evaluations will occur up to 30 days
次要结局
- Total number of BARC type 2, 3, or 5 bleeding events(Evaluations will occur up to 30 days)
- Number of Vascular access complications defined as the composite of arteriovenous fistula, arterial pseudoaneurysm, or arterial occlusion requiring intervention;(Evaluations will occur up to 30 days)
- Number of participants with Radial artery occlusion(Evaluations will occur up to 30 days)
- Number of participants with Access site crossover(Measured during procedure)
- Number of other vascular access related complications(Evaluations will occur up to 30 days)
- Total procedure time(Measured during procedure)
- Time to ambulation(Measured up to 24 hours after procedure completion)
- Number of participants with unplanned coronary revascularization(Evaluations will occur up to 30 days)
- Number of all cause death and cardiac death(Evaluations will occur up to 30 days)
- Number of participants with Myocardial Infarction(Evaluations will occur up to 30 days)
- Number of participants with Stroke(Evaluations will occur up to 30 days)
- Measure of Radiation Dose(Measured during procedure)
- Fluoroscopy Time(Measured during procedure)
- Contrast volume(Measured during procedure)
- Number of participants with Procedural Success(Evaluations will occur up to 30 days)
- Duration of hospital stay and frequency of same day discharge(Evaluations will occur up to 30 days)
- Patient Preference Survey: Radial Vs Femoral Access(Evaluations will occur up to 30 days)