Gadofosveset Imaging of Chronic Total Peripheral Artery Occlusion (CTO)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Conspicuity of occluded arteries after contrast exposure.
研究概览
简要总结
This study will test how well a new contrast agent (dye) used in magnetic resonance imaging (MRI) can help visualize totally blocked arteries that normally supply blood to the neck, arms or legs. Currently used agents work well in visualizing normal or partly blocked arteries (arteries that have some blood flowing through them), but only poorly in totally blocked arteries. This study will see if a contrast agent called gadofosveset can better brighten images of completely blocked arteries. Gadofosveset is approved in Europe for use in MRI scans, but is still considered experimental in the United States.
People 18 years of age or older with known or suspected total blockage of an artery to the neck, arm or leg may be eligible for this study.
Participants undergo MRI scanning with gadofosveset contrast dye. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the subject lies on a table that can slide in and out of the tubular scanner, wearing earplugs to muffle loud noises that occur during the scanning process. The procedure lasts about 1.5 to 2 hours, during which the subject may be asked to hold his or her breath several times for as long as 5 to 20 seconds. During the procedure, gadofosveset is injected and several kinds of MRI pictures are taken to understand better how the new agent works. Subjects may be asked to undergo a second scan using conventional MRI contrast dye
详细描述
Repairing totally occluded peripheral arteries remains challenging because they are not visualized using available imaging technologies. Contrast-enhanced magnetic resonance angiography (CE-MRA), X-ray computed tomography angiography (CTA), and invasive radiocontrast digital subtraction angiography (DSA) all rely on blood flow within arteries that are not totally occluded. Where the arterial lumen is totally occluded, contrast does not enter and the artery remains invisible. As a result, physicians have difficulty identifying a pathway or trajectory for catheter devices in order to improve blood flow using angioplasty.
Gadofosveset, an albumin-binding MRI contrast agent that is commercially available outside the United States, may accumulate in the walls of occluded arteries through a mechanism that is not known.
The goal of this protocol is to determine whether gadofosveset has value in planning catheter trajectories in totally occluded peripheral arteries. We propose to study the gadofosveset contrast enhancement patterns in occluded peripheral artery segments in up to 20 patients with known occluded iliac, femoral, and shoulder arteries being considered for catheter-based treatment.
This research may have value in planning and conducting minimally invasive treatments using conventional X-ray guidance and possibly in the future using investigational real-time MRI guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Conspicuity of occluded arteries after contrast exposure.
次要结局
未报告次要终点