A Prospective Randomized Feasibility Trial Comparing Angiography and Angiography With IVUS for Treatment of Hemodialysis Access Failures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Change in characteristics of lesion within the vessel
研究概览
简要总结
The reason the investigators are doing this study is to compare the results of angiography versus angiography with intravascular ultrasound in dialysis grafts/fistulas that are blocked.
详细描述
Patients with kidney failure have a fistula or graft for long-term dialysis in order for the dialysis machine to draw blood, filter it, and give it back to the patient. Over time, the fistula or graft may not work well enough to use for dialysis, most commonly because the veins may develop "scar tissue" within and around them that narrows the vein resulting in poor flow or complete blockage.
These blockages are commonly opened with wires, balloons (a procedure called angioplasty), and stents. These blockages are seen with angiography, a special type of x-ray used with a dye that shows the inside of the blood vessels. Intravascular ultrasound (IVUS) is a type of imaging that uses sound waves to produce an image of the inside of blood vessels and to see their condition. Currently, it is not known if angiography alone or angiography with IVUS has better results. The reason we are doing this study is to compare the results of angiography versus angiography with IVUS.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old
- •Male or female (non-pregnant females)
- •Patients with hemodialysis access failure (arteriovenous fistulae or arteriovenous grafts)
- •Patients must undergo elective angiographies (fistulograms) based on surveillance duplex ultrasound findings (stenosis)
- •Patients with outflow stenoses between 1 cm distal to an arterial anastamosis and clavicle in AV fistulae or between venous anastamosis and clavicle in AV grafts found on surveillance duplex ultrasound
排除标准
- •Patients with other etiologies (inflow lesions, intragraft lesions, hypercoagulable states, lesions not readily amenable to stenting), advanced failures (thrombosis, central venous occlusion), and non-routine access conformations (chest wall/groin grafts, balloon assisted maturation)
结局指标
主要结局
Change in characteristics of lesion within the vessel
时间窗: every 3 months - up to 2 years
This will include vessel diameters proximal and distal to lesions, percent stenosis, and lesion lengths.
次要结局
未报告次要终点