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NCT04571099

Next Generation X-ray Imaging System

Completed Results posted Last updated 2 October 2024
What this trial tests

trial in Stroke, Acute in 28 participants. Completed in 26 March 2021.

Timeline
8 October 2020
Primary endpoint
26 March 2021
26 March 2021

Quick facts

Lead sponsorPhilips Clinical & Medical Affairs Global
StatusCompleted
Study typeOBSERVATIONAL
Enrollment28
Start date8 October 2020
Primary completion26 March 2021
Estimated completion26 March 2021
Sites1 location across Sweden

Conditions studied

Sponsor

Philips Clinical & Medical Affairs Global — full company profile →

Who can join

50 and older, any sex, with Stroke, Acute. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT) Primary · 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.

GroupValue95% CI
I - Ischemic Stroke, no Thrombectomy90
II - Ischemic Stroke, Thrombectomy90
Percentage of Dual Layer CBCT Images With Non-inferior Vessel Tree Visibility Compared to CTA (Reference Standard) Secondary · 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 segm

GroupValue95% CI
II - Ischemic Stroke, Thrombectomy77
Intracranial Hemorrhage Detection Accuracy (CBCT With CT as Reference Standard) Secondary · 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.

GroupValue95% CI
II - Ischemic Stroke, Thrombectomy100
III - Hemorrhagic Stroke100

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Dual-Layer Detector Cone-Beam CT Angiography for Stroke Assessment: First-in-Human Results (the Next Generation X-ray Imaging System Trial).
    Ståhl F, Almqvist H, Kolloch J, Aspelin Å, et al · · 2023 · cited 2× · PMID 37055159 · DOI 10.3174/ajnr.a7835
  2. Stroke Evaluation in the Interventional Suite Using Dual-Layer Detector Cone-Beam CT: a First-in-human Prospective Cohort Study (the Next Generation X-ray Imaging System Trial).
    Ståhl F, Almqvist H, Aspelin Å, Kolloch J, et al · · 2024 · cited 1× · PMID 39052054 · DOI 10.1007/s00062-024-01439-7
  3. ESOC 2022 Abstract Book
    · 2022

Verify or expand the search:

Other recruiting trials for Stroke, Acute

Currently open trials in the same condition.

Other Philips Clinical & Medical Affairs Global trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04571099.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing