Large Vessel OcclusionNCT07546019
Evaluation of Heuron CTA for Detecting Suspected Large Vessel Occlusion Using Brain CT Angiography
An observational study of Large Vessel Occlusion, run by Heuron Inc. at 1 site in South Korea.
Trial summary
This study evaluates Heuron CTA, a software that helps doctors detect blockages in brain blood vessels using CT angiography images. The software's results will be compared with diagnoses made by medical specialists to assess its accuracy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Large Vessel Occlusion
- What is being tested?
- Heuron CTA
- Type of treatment
- Medical device
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Feb 2024to 21 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: (1) Adults over 19 years old (2) Brain CTA images acquired (3) who confirmed with large vessel occlusion(positive group) or not large vessel occlusion or normal(negative group)
Who may be able to join
- Adults aged 19 years or older who visited the clinical trial institution for brain CTA images between January 2020 and May 2021, and from November 2021 until IRB approval
- Individuals classified into the positive or negative group based on the following criteria:
- Positive group: Diagnosed with large vessel occlusion due to occlusion of the vessels between ICA and MCA-M1 after taking brain CTA images -- Negative group: Diagnosed as either not having large vessel occlusion or as normal after brain CTA images
Who cannot join
- Cases with poor-quality or incomplete brain CTA images7)
- Cases where intracranial prosthetic implants (e.g., catheters, coils) were present
- Cases that were previously used for AI model training and internal validation
- Any other cases deemed unsuitable for participation in the clinical trial based on the investigator's judgment * Specific reasons were recorded in the case report form.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Gachon University Gil Medical Center
Incheon, Namdong-gu, 21565
About this study
Official title: A Single-Center, Evaluator-Blinded, Retrospective, Pivotal Clinical Trial to Evaluate the Efficacy of Heuron CTA, a Brain Image Detection and Diagnostic Support Software, for Assessing Suspected Large Vessel Occlusion Using Brain CT Angiography
This study evaluates Heuron CTA, a software that helps doctors detect blockages in brain blood vessels using CT angiography images. The software's results will be compared with diagnoses made by medical specialists to assess its accuracy. If it performs well, it may help doctors diagnose these conditions more quickly and effectively.
Read the detailed description
This study aims to evaluate the efficacy of Heuron CTA in assisting the diagnosis of suspected large vessel occlusion using brain CT angiography. The study will determine whether Heuron CTA meets the predefined clinical success criteria, where the lower bound of the 95% confidence interval for sensitivity and specificity exceeds 80%, using the final clinical diagnosis by a group of surgeons as the reference standard. If Heuron CTA meets the success criteria, it will be considered effective in assisting in the diagnosis of large vessel occlusion.
- Conditions
- Large Vessel Occlusion
- Being tested
- Heuron CTA
- Keywords
- Heuron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heuron CTADevice
This software automatically analyzes Computed Tomography Angiography (CTA) images to detect suspected large vessel occlusion, assisting surgeons in their diagnostic decisions
| Study group | Role | What they receive |
|---|---|---|
| Positive Group | Diagnosed with large vessel occlusion due to occlusion of the vessels between ICA and MCA-M1 after taking brain CTA images Receives: Device: Heuron CTA | |
| Negative group | Diagnosed as either not having large vessel occlusion or as normal after brain CTA images Receives: Device: Heuron CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion
Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion were assessed by calculating their 95% confidence intervals (CIs) and determining whether the lower bound exceeded the clinical success criterion of 80%. The Clopper-Pearson confidence interval method12) was used to calculate the 95% CI.
Measured: Within 8 weeks after collecting data
Secondary outcomes (3)
Accuracy, ROC Curve and AUC value for classifying suspected large vessel occlusion
Using the calculation method above, the accuracy for classifying suspected large vessel occlusion with a 95% confidence interval. The accuracy calculation method is the following: 100 × [TP + TN] / N. A ROC Curve was generated with the x-axis representing the false positive rate (1-specificity) and the y-axis representing sensitivity. The AUC value was calculated as the area under the ROC curve, with a 95% confidence interval provided.
Measured: Within 8 weeks after collecting data
Sensitivity of Heuron CTA in determining suspected large vessel occlusion for each occluded vessel
For the positive group, Sensitivity of Heuron CTA in determining suspected large vessel occlusion for each occluded vessel was calculated, along with a 95% confidence interval.
Measured: Within 8 weeks after collecting data
Sensitivity and specificity of Heuron CTA in determining suspected large vessel occlusion based on adjusted occlusion criteria
When the reference standard categories of None, Stenosis but not near occlusion, and Near occlusion were classified as "Large Vessel Occlusion Negative," and Occlusion was classified as "Large Vessel Occlusion Positive," the sensitivity and specificity of Heuron CTA were calculated along with a 95% confidence interval.
Measured: Within 8 weeks after collecting data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start28 Feb 2024
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Vessel OcclusionStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heuron Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546019
- Sponsor's protocol ID
- HR-CTA-01
- Other IDs
- GCIRB2024-003
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Evaluator-Blinded, Retrospective, Pivotal Clinical Trial to Evaluate the Efficacy of Heuron CTA, a Brain Image Detection and Diagnostic Support Software, for Assessing Suspected Large Vessel Occlusion Using Brain CT Angiography
- ClinicalTrials.gov ID
- NCT07546019
- Acronym / sponsor ID
- HR-CTA-01
- Conditions
- Large Vessel Occlusion
- Keywords
- Heuron
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Heuron Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates Heuron CTA, a software that helps doctors detect blockages in brain blood vessels using CT angiography images. The software's results will be compared with diagnoses made by medical specialists to assess its accuracy. If it performs well, it may help doctors diagnose these conditions more quickly and effectively.
Detailed description
This study aims to evaluate the efficacy of Heuron CTA in assisting the diagnosis of suspected large vessel occlusion using brain CT angiography. The study will determine whether Heuron CTA meets the predefined clinical success criteria, where the lower bound of the 95% confidence interval for sensitivity and specificity exceeds 80%, using the final clinical diagnosis by a group of surgeons as the reference standard. If Heuron CTA meets the success criteria, it will be considered effective in assisting in the diagnosis of large vessel occlusion.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Group | – | Device: Heuron CTADiagnosed with large vessel occlusion due to occlusion of the vessels between ICA and MCA-M1 after taking brain CTA images |
| Negative group | – | Device: Heuron CTADiagnosed as either not having large vessel occlusion or as normal after brain CTA images |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (1) Adults over 19 years old (2) Brain CTA images acquired (3) who confirmed with large vessel occlusion(positive group) or not large vessel occlusion or normal(negative group)
Key inclusion criteria (3 listed)
- Adults aged 19 years or older who visited the clinical trial institution for brain CTA images between January 2020 and May 2021, and from November 2021 until IRB approval
- Individuals classified into the positive or negative group based on the following criteria:
Key exclusion criteria (4 listed)
- Cases with poor-quality or incomplete brain CTA images7)
- Cases where intracranial prosthetic implants (e.g., catheters, coils) were present
- Cases that were previously used for AI model training and internal validation
- Any other cases deemed unsuitable for participation in the clinical trial based on the investigator's judgment * Specific reasons were recorded in the case report form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heuron CTAThis software automatically analyzes Computed Tomography Angiography (CTA) images to detect suspected large vessel occlusion, assisting surgeons in their diagnostic decisions | Device | Negative group, Positive Group |
Primary outcome
Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion
Time frame: Within 8 weeks after collecting data
Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion were assessed by calculating their 95% confidence intervals (CIs) and determining whether the lower bound exceeded the clinical success criterion of 80%. The Clopper-Pearson confidence interval method12) was used to calculate the 95% CI.
3 secondary outcomes
Accuracy, ROC Curve and AUC value for classifying suspected large vessel occlusion
Time frame: Within 8 weeks after collecting data
Sensitivity of Heuron CTA in determining suspected large vessel occlusion for each occluded vessel
Time frame: Within 8 weeks after collecting data
Sensitivity and specificity of Heuron CTA in determining suspected large vessel occlusion based on adjusted occlusion criteria
Time frame: Within 8 weeks after collecting data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Large Vessel Occlusion, run by Heuron Inc. at 1 site in South Korea.
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 4 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 22 Apr 2026. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and specificity of Heuron CTA in determining the presence of suspected large vessel occlusion (time frame: Within 8 weeks after collecting data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.