Next Generation X-ray Imaging System

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT)

Time frame: 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 outcomes

Percentage of Dual Layer CBCT Images With Non-inferior Vessel Tree Visibility Compared to CTA (Reference Standard)

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Sep 30, 2020
Registry last updated: Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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