Next Generation X-ray Imaging System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT)
研究概览
简要总结
Philips Healthcare has developed a next generation Allura investigational device. The intended purpose of the investigational device is to perform neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures on human patients. The goal of this study is to investigate the accuracy of the next generation Allura investigational device to determine the extent and localization of ischemic stroke changes in brain tissue.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has signed and dated the Informed Consent Form (ICF)
- •Age ≥ 50 years old
- •Clinical and radiological signs consistent with acute stroke I. Patient diagnosed with ischemic stroke of the anterior circulation and not eligible for thrombectomy. II. Patient diagnosed with ischemic stroke of the anterior circulation and subjected to thrombectomy. III. Patient diagnosed with hemorrhagic stroke.
排除标准
- •Pregnant or breastfeeding women.
- •Previous stroke or parenchymal damage/defects in anterior circulation territories (only applicable for subjects included by criterion 3.I or 3.II).
- •Subject participates in a potentially confounding drug or device trial during the course of the study.
- •Participation in the study exposes the subject to risk, as assessed at the discretion of the treating physician.
- •All subjects who meet an exclusion criteria according to national law.
- •Subject or subject family member is a known Philips employee.
结局指标
主要结局
Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT)
时间窗: Within 2 days after procedure
Accuracy of dual energy CBCT ASPECTS score to determine the extent and localization of ischemic stroke changes in brain tissue, evaluated by three independent neuroradiologists, using non enhanced CT ASPECTS as reference standard. The Alberta stroke program early CT score (ASPECTS) is a 10-point quantitative topographic CT scan score used for middle cerebral artery (MCA) stroke patients. Segmental estimation of the middle cerebral artery (MCA) vascular territory is made, and 1 point is deducted from the initial score of 10 for every region involved.
次要结局
- Percentage of Dual Layer CBCT Images With Non-inferior Vessel Tree Visibility Compared to CTA (Reference Standard)(Within 2 days after procedure)
- Intracranial Hemorrhage Detection Accuracy (CBCT With CT as Reference Standard)(Within 2 days after procedure)