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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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 2 days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with age 50 or older, of both genders. Patients are considered to be enrolled in the study after they have signed the informed consent form.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Söderman, MD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37055159 | Result | Stahl F, Almqvist H, Kolloch J, Aspelin A, Gontu V, Hummel E, van Vlimmeren M, Simon M, Thran A, Holmberg A, Mazya MV, Soderman M, Delgado AF. Dual-Layer Detector Cone-Beam CT Angiography for Stroke Assessment: First-in-Human Results (the Next Generation X-ray Imaging System Trial). AJNR Am J Neuroradiol. 2023 May;44(5):523-529. doi: 10.3174/ajnr.A7835. Epub 2023 Apr 13. | |
| 39052054 |
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| ID | Title | Description |
|---|---|---|
| FG000 | I - Ischemic Stroke, no Thrombectomy | I - Ischemic stroke, no thrombectomy |
| FG001 | II - Ischemic Stroke, Thrombectomy | II - Ischemic stroke, thrombectomy |
| FG002 | III - Hemorrhagic Stroke | III - Hemorrhagic stroke |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | I - Ischemic Stroke, no Thrombectomy | I - Ischemic stroke, no thrombectomy |
| BG001 | II - Ischemic Stroke, Thrombectomy | II - Ischemic stroke, thrombectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Each ASPECTS region was assessed individually (affected versus non-affected). Hemorrhagic stroke patients were excluded for this analysis. | Posted | Number | percentage of gold standard | Within 2 days after procedure |
|
48-hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | I - Ischemic Stroke, no Thrombectomy | I - Ischemic stroke, no thrombectomy | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marijke van Vlimmeren | Philips Clinical & Medical Affairs Global | +31 6 31042408 | marijke.van.vlimmeren@philips.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2020 | Nov 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Within 2 days after procedure |
| 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. | Within 2 days after procedure |
| Derived |
| Stahl F, Almqvist H, Aspelin A, Kolloch J, Ghalamkari O, Gontu V, Schafer D, van de Haar P, Engel KJ, van Nijnatten F, Holmberg A, Mazya MV, Soderman M, Delgado AF. 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). Clin Neuroradiol. 2024 Dec;34(4):929-937. doi: 10.1007/s00062-024-01439-7. Epub 2024 Jul 25. |
| BG002 | III - Hemorrhagic Stroke | III - Hemorrhagic stroke |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| OG001 | II - Ischemic Stroke, Thrombectomy | II - Ischemic stroke, thrombectomy |
| OG002 | III - Hemorrhagic Stroke | III - Hemorrhagic stroke |
|
|
| 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. | Contrast enhanced scans where not collected for Ischemic stroke, no thrombectomy (I) & Hemorrhagic stroke patients (III), hence where not part of this analysis. | Posted | Number | percentage of gold standard | Within 2 days after procedure |
|
|
|
| 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. | 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). | Posted | Number | percentage of gold standard | Within 2 days after procedure |
|
|
|
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | II - Ischemic Stroke, Thrombectomy | II - Ischemic stroke, thrombectomy | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | III - Hemorrhagic Stroke | III - Hemorrhagic stroke | 0 | 3 | 0 | 3 | 0 | 3 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Male |
|