Next Generation X-ray Imaging System

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Dual Layer CBCT Images With Non-inferior Vessel Tree Visibility Compared to CTA (Reference Standard)	Within 2 days after procedure	Percentage of images made with new investigational device (dual layer CBCT) rated non-inferior vessel visibility compared to CTA (reference standard). Vessel visibility was evaluated separately as indicators of diagnostic quality on 5-point Likert scales, adopted with slight modifications from previous studies (5: excellent vessel visibility or no artifacts, 1:vessel not visible or extensive artifacts). Sixteen intracranial arterial segments were prospectively defined for the reader study. The score difference between DL-CBCTA and CTA for each segment in each patient determined whether a segment was considered inferior, equal or superior.
Intracranial Hemorrhage Detection Accuracy (CBCT With CT as Reference Standard)	Within 2 days after procedure	Accuracy of images made with new investigational device (dual layer CBCT) to determine the presence of intracranial hemorrhage (Yes/No) using non enhanced CT as the reference standard as judged by the individual reader (neuroradiologist) through blinded reader assessment.