Minimizing Radiographic Contrast Administration During Coronary Angiography Using a Novel Contrast Reduction System: A Multicenter Observational Study of the DyeVert™ Plus Contrast Reduction System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 8
- 主要终点
- Percentage of Contrast Media Volume Saved
研究概览
简要总结
This is a prospective, single arm, multi-center, observational clinical study of the DyeVert Plus System. The DyeVert Plus System is an FDA-cleared device designed to reduce contrast media volume delivered during angiography and permit real-time contrast media volume monitoring.
详细描述
The purpose of this observational study is to evaluate the amount of contrast media saved using DyeVert Plus in coronary angiographic and/or interventional procedures performed with manual injection and evaluate the impact of predetermined thresholds and real-time monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Scheduled to undergo CAG and/or PCI
- •Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2
排除标准
- •Acute ST-elevation myocardial infarction or known coronary artery fistulas
- •Body mass index (BMI) >40
- •Currently pregnant
- •Undergoing a chronic total occlusion procedure or optical coherence tomography analysis
- •Planning to undergo transcatheter aortic valve replacement within 72 hr of the index procedure
- •A condition known to require large volumes of contrast (>10 mL) for each injection
结局指标
主要结局
Percentage of Contrast Media Volume Saved
时间窗: At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure
The percentage of contrast media volume saved (diverted) over the total procedure as reported on the DyeVert Plus display at the end of each case.
次要结局
- Evaluation of Adverse Events Through Discharge (From the Index Procedure)(From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days))