Stroke, AcuteNCT04571099
Next Generation X-ray Imaging System
An observational study of Stroke, Acute, run by Philips Clinical & Medical Affairs Global at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke, Acute
- How many people
- 28 participants
- Where
- 1 siteSweden
- Study dates
- 8 Oct 2020to 26 Mar 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke, Acute
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 2 days after procedure
Secondary outcomes (2)
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.
Measured: 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.
Measured: Within 2 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start8 Oct 2020
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Söderman, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571099
- Sponsor's protocol ID
- XCY612-130814
- Status last verified
- Jun 2024
- First submitted
- 4 Sep 2020
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37055159Stahl 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.
PubMed 39052054
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation X-ray Imaging System
- ClinicalTrials.gov ID
- NCT04571099
- Acronym / sponsor ID
- XCY612-130814
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Posted 2 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 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
Intracranial Hemorrhage Detection Accuracy (CBCT With CT as Reference Standard)
Time frame: Within 2 days after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37055159Stahl 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.
- Derived from this study: PubMed 39052054Stahl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Söderman, MD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Philips Clinical & Medical Affairs Global at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic Stroke Diagnostic Accuracy (CBCT Versus CT) (time frame: Within 2 days after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571099, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.