Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Primary Endpoint: Area Under the Curve (AUC), Sensitivity, and Specificity of VCI When Compared Against Standard of Care Imaging.
研究概览
简要总结
This study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (PROBE), non-significant risk (NSR) device study including up to 420 evaluable subjects measured with the study device(s) and up to 40 non-evaluable subjects for the training phase.
详细描述
The purpose of this study is to collect robust data from NovaGuide 2 Intelligent Ultrasound System to validate the Velocity Curvature Index (VCI) as a diagnostic biomarker tool to drive clinical decision making for assessing cerebral vascular occlusions confirmed by standard of care Computed Tomography Angiography (CTA) imaging.
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
- •Subject aged 18 years and older referred for evaluation of possible stroke.
- •Subject receives Computed Tomography Angiography (CTA) imaging for the assessment of stroke.
- •Subject or Legally Authorized Representative has the ability to provide informed consent and comply with the protocol.
排除标准
- •Head CT findings consistent with acute primary intracranial hemorrhage (ICH), etc.
- •Subjects with occlusions in the distal or posterior circulation arteries.
- •Subjects who underwent partial or full craniotomy
- •Additional intracranial pathologies present (tumor, hydrocephalus, etc.)
- •Anticipated insufficient time to acquire a complete TCD scan as described by the protocol
- •Subjects who have a physical limitation preventing placement of the system.
结局指标
主要结局
Primary Endpoint: Area Under the Curve (AUC), Sensitivity, and Specificity of VCI When Compared Against Standard of Care Imaging.
时间窗: 1 day
The primary endpoint for both Phase 1 and Phase 2 of the study is to measure the AUC, Sensitivity, and Specificity of Velocity Curvature Index (VCI) when compared against standard of care CTA imaging for large vessel occlusion assessment. Initial assessment of outcome will be done after 18 months of study start and complete assessment will be done at the end of study's Phase 2.
次要结局
未报告次要终点