A Randomized Comparison of RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Amount of contrast used
研究概览
简要总结
Increased use of radial access for cardiac catheterization is being advocated because studies have showed lower arterial access related complication rates and higher patient satisfaction as compared to femoral access. However, little is known on patients with prior coronary artery bypass graft (CABG). The RADIAL CABG Trial is a randomized-controlled trial proposed to test the hypothesis that bypass graft angiography and intervention via radial access provides lower vascular complication rates, similar contrast and equipment utilization and higher patient satisfaction when compared with transfemoral approach.
详细描述
This is a phase III, single-center, prospective, randomized trial that will compare resource utilization, clinical outcomes and patient satisfaction between radial and femoral access for patients with prior coronary artery bypass graft (CABG)surgery undergoing coronary and graft angiography and intervention. During clinically-indicated coronary angiography of patients with prior CABG, the amount resources used, radiation exposure to patients and operators, occurence of complications and patients satisfaction will be compared between the two treatment arms to determine whether compared to femoral approach radial access will result in:
- similar contrast utilization (primary endpoint)
- similar procedure time (secondary endpoint)
- similar fluoroscopy time (secondary endpoint)
- similar radiation exposure of the patient - measured as DAP [dose area product] and AK [air kerma] (secondary endpoint)
- similar radiation exposure of the operators using portable radiation dose measuring devices (secondary endpoint)
- similar number and types of catheters and guidewires used (secondary endpoint)
- reduction in vascular access complications (secondary endpoint)
- reduction in overall complications (vascular access complications,injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) (secondary endpoint)
- higher patient satisfaction as measured by standardized survey 24-hours after the procedure (secondary endpoint)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18-years
- •Prior coronary artery bypass graft surgery
- •Referred for clinically-indicated coronary and graft angiography and/or intervention
- •Able to provide informed consent
排除标准
- •Known pathologic Allen's test
- •Known difficulty that limits vascular access at the femoral or radial arteries
- •Age > 90
结局指标
主要结局
Amount of contrast used
时间窗: 24 hours
次要结局
- Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma](24 hours)
- Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure(24 hours)
- Total procedure time(24 hours)
- Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices(24 hours)
- Number of catheters and wires used(24 hours)
- Fluoroscopy time(24 hours)
- Performance of ascending aortic angiography to identify patent bypass grafts(24 hours)
- Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arterio-venous fistula formation, dissection, limb ischemia, bleeding)(24 hours)
- Overall Complications (vascular access complications, injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction)(24 hours)
研究者
Emmanouil Brilakis
Director, Cardiac Catheterization Laboratories
North Texas Veterans Healthcare System