N/A
N=28
Next Generation X-ray Imaging System
Stroke, Acute
Bottom Line
View on ClinicalTrials.gov: NCT04571099 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT) — 90; 90 percentage of gold standard
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Philips Clinical & Medical Affairs Global
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT) |
90; 90 | — |
| SECONDARY Percentage of Dual Layer CBCT Images With Non-inferior Vessel Tree Visibility Compared to CTA (Reference Standard) |
77 | — |
| SECONDARY Intracranial Hemorrhage Detection Accuracy (CBCT With CT as Reference Standard) |
100; 100 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04571099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.