Stroke, Acute
Conditions
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.
Interventions
None listed
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient has signed and dated the Informed Consent Form (ICF) 2. Age ≥ 50 years old 3. 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
1. Pregnant or breastfeeding women. 2. Previous stroke or parenchymal damage/defects in anterior circulation territories (only applicable for subjects included by criterion 3.I or 3.II). 3. Subject participates in a potentially confounding drug or device trial during the course of the study. 4. Participation in the study exposes the subject to risk, as assessed at the discretion of the treating physician. 5. All subjects who meet an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| I - Ischemic Stroke, no Thrombectomy I - Ischemic stroke, no thrombectomy | 3 |
| II - Ischemic Stroke, Thrombectomy II - Ischemic stroke, thrombectomy | 22 |
| III - Hemorrhagic Stroke III - Hemorrhagic stroke | 3 |
| Total | 28 |
Baseline characteristics
| Characteristic | I - Ischemic Stroke, no Thrombectomy | II - Ischemic Stroke, Thrombectomy | III - Hemorrhagic Stroke | Total |
|---|---|---|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 9.6 | 74.5 years STANDARD_DEVIATION 9.7 | 76.7 years STANDARD_DEVIATION 7.8 | 74.1 years STANDARD_DEVIATION 9.6 |
| Body Mass Index (BMI) | 28.5 kg/m2 STANDARD_DEVIATION 5.7 | 25.4 kg/m2 STANDARD_DEVIATION 5.1 | 22.8 kg/m2 STANDARD_DEVIATION 1 | 25.6 kg/m2 STANDARD_DEVIATION 5.2 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Sweden | 3 participants | 22 participants | 3 participants | 28 participants |
| Sex: Female, Male Female | 2 Participants | 16 Participants | 0 Participants | 18 Participants |
| Sex: Female, Male Male | 1 Participants | 6 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 22 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 22 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 22 | 0 / 3 |
Outcome results
Primary
Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT)
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.
Time frame: Within 2 days after procedure
Population: Each ASPECTS region was assessed individually (affected versus non-affected).~Hemorrhagic stroke patients were excluded for this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| I - Ischemic Stroke, no Thrombectomy | Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT) | 90 percentage of gold standard |
| II - Ischemic Stroke, Thrombectomy | Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT) | 90 percentage of gold standard |
Secondary
Intracranial Hemorrhage Detection Accuracy (CBCT With CT as Reference Standard)
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.
Time frame: Within 2 days after procedure
Population: The target for hemorrhage detection was set to not miss any bleeding given a limited number of participants.~Three primary hemorrhages (III - Hemorrhagic stroke) and five hemorrhagic transformations of ischemic stroke (II - Ischemic stroke, thrombectomy) were detected in the reference CT examinations. Hence, eight matched scans with hemorrhages were included in the analysis (28% of all scans).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| II - Ischemic Stroke, Thrombectomy | Intracranial Hemorrhage Detection Accuracy (CBCT With CT as Reference Standard) | 100 percentage of gold standard |
| III - Hemorrhagic Stroke | Intracranial Hemorrhage Detection Accuracy (CBCT With CT as Reference Standard) | 100 percentage of gold standard |
Secondary
Percentage of Dual Layer CBCT Images With Non-inferior Vessel Tree Visibility Compared to CTA (Reference Standard)
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.
Time frame: Within 2 days after procedure
Population: Contrast enhanced scans where not collected for Ischemic stroke, no thrombectomy (I) \& Hemorrhagic stroke patients (III), hence where not part of this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| II - Ischemic Stroke, Thrombectomy | Percentage of Dual Layer CBCT Images With Non-inferior Vessel Tree Visibility Compared to CTA (Reference Standard) | 77 percentage of gold standard |