REduction of Contrast Via DyeVert Used in CTO Procedures (REDUCe)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Contrast volume administration during CTO PCI
研究概览
简要总结
The is an observational, prospective study to evaluate the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
详细描述
The DyeVert System is a disposable, FDA-approved device that interfaces with standard manifold systems to reduce the amount of contrast used in catheterization procedures, while maintaining fluoroscopic image opacity.
No study has assessed use of the system in CTO PCI. It would be expected that savings in CTO procedures may be less than non-CTO procedures due to catheter sizing and number of open guide injections required. Open guide injections through larger catheters do not provide for the as much resistance, therefore decreasing the need for contrast to be diverted
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects undergoing CTO PCI at each of the participating centers.
- •Contrast volume recorded during CTO PCI
- •Subjects included in the "Multicenter Registry of Chronic Total Occlusion Interventions" study (Allina IRB approval # 948134-1)
排除标准
- 未提供
结局指标
主要结局
Contrast volume administration during CTO PCI
时间窗: During the CTO PCI procedure
The hypothesis of the study is that use of the DyeVert System will result in lower contrast volume, determined through real-time monitoring with the DyeVert System.
次要结局
未报告次要终点