Intracranial AneurysmIDEAL2NCT07124624
Stepped-Wedge Cluster Randomized Trial of AI-Assisted CTA Detection for Intracranial Aneurysms in Regional Hospitals
A study testing AI-Assisted CTA Interpretation and Standard CTA Interpretation in people with Intracranial Aneurysm and CT Angiography, run by Jinling Hospital, China.
Trial summary
This study (IDEAL 2) is a nationwide stepped-wedge cluster-randomized trial designed to prospectively enroll over 14,400 patients undergoing outpatient head CT angiography (CTA). The trial will be conducted across more than 72 regional hospitals in China. Clusters were randomly assigned to nine randomization groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysm, CT Angiography, AI (Artificial Intelligence)
- What is being tested?
- AI-Assisted CTA Interpretation and Standard CTA Interpretation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,400 participants
- Where
- No sites listed yet
- Study dates
- 9 Oct 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Patients in the outpatient setting who are scheduled to undergo head CTA scanning
Who cannot join
- Age < 18 years
- History of cerebrovascular surgery involving any metallic implants (e.g., aneurysm embolization, aneurysm clipping, or vascular stenting)
- Modified Rankin Scale (mRS) score > 3
- Refuse to sign written informed consent
- Contraindications to CTA examination
- CTA scan failure, incomplete imaging data, or image quality insufficient for diagnostic evaluation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of an AI-Driven CT Angiography Model on Intracranial Aneurysm Detection and Clinical Outcomes in Regional Hospitals (IDEAL2): A Nationwide Stepped-Wedge Cluster-Randomized Trial
This study (IDEAL 2) is a nationwide stepped-wedge cluster-randomized trial designed to prospectively enroll over 14,400 patients undergoing outpatient head CT angiography (CTA). The trial will be conducted across more than 72 regional hospitals in China. Clusters were randomly assigned to nine randomization groups. In accordance with the stepped-wedge design, clusters will sequentially transition from the control condition (standard human diagnosis) to the intervention condition (AI-assisted diagnosis) at regular intervals over a 10-month period, until all clusters receive the intervention. The primary outcome is the detection rate of intracranial aneurysms. Secondary outcomes include patient prognosis and clinical outcomes.
Read the detailed description
A multicenter, stepped-wedge cluster-randomized trial will be conducted in regional hospitals, specifically prefecture-level and county-level institutions across China. Each cluster (i.e., hospital) will enroll approximately 200 patients undergoing head computed tomography angiography (CTA), yielding a total sample size of at least 14,400 participants. The trial consists of nine steps, each lasting one month. Clusters will transition sequentially from the control condition to the intervention condition based on stratified randomization, until all clusters have received the intervention.
In the control group, diagnoses and treatments will follow local standard clinical protocols. In the intervention group, diagnostic procedures will be supported by an artificial intelligence (AI)-assisted system. The primary outcome is the detection rate of intracranial aneurysms, as determined from radiology reports at the patient level. Secondary outcomes include additional diagnostic performance metrics on CTA, such as the detection of intracranial arterial stenosis, occlusion, and tumors.
Follow-up evaluations at 3 and 12 months will assess treatment-related indicators-including repeat head CTA or magnetic resonance angiography (MRA), hospitalization rates, and digital subtraction angiography (DSA) utilization-as well as clinical outcomes related to aneurysm events. These measures aim to evaluate both the short- and long-term impacts of AI-assisted diagnosis on routine clinical practice and patient prognosis.
- Conditions
- Intracranial Aneurysm, CT Angiography, AI (Artificial Intelligence), Cluster Randomized Trial
- Being tested
- AI-Assisted CTA Interpretation, Standard CTA Interpretation
- Keywords
- Intracranial aneurysm, AI (Artificial Intelligence), Stepped-wedge cluster-randomized trial
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted CTA InterpretationDevice
A locked, independently validated deep learning model was used to assist radiologists in interpreting head CTA scans. The model was trained on 16,546 CTA cases and externally validated on an independent set of 900 DSA-verified CTA cases, achieving a patient-level sensitivity of 0.943 and an average of 0.187 false positives per case.
Standard CTA InterpretationDiagnostic test
Head CTA interpretation performed by radiologists using local routine diagnostic workflows without AI support.
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Diagnosis | Experimental | Patients in this group will undergo head CTA, interpreted by radiologists with the assistance of a previously validated deep learning AI model. The model highlights suspected aneurysm candidates on the CTA images to support diagnostic decision-making. Receives: Device: AI-Assisted CTA Interpretation |
| Standard Diagnosis | Active comparator | Patients in this group will undergo head CTA, which will be interpreted by radiologists following standard local diagnostic protocols. No AI assistance will be provided during image interpretation. Receives: Diagnostic Test: Standard CTA Interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of intracranial aneurysms
The proportion of patients diagnosed with intracranial aneurysms among all individuals undergoing CTA during the observation period. This outcome is used to compare the diagnostic effectiveness of conventional radiologist interpretation based on local clinical practice versus AI-assisted diagnosis in detecting intracranial aneurysms.
Measured: Day 1
Secondary outcomes (11)
Detection rates of other intracranial lesions except aneurysms
The proportion of patients diagnosed with intracranial arterial stenosis, occlusion, arteriovenous malformation (AVM), Moyamoya disease, or other vascular abnormalities among all individuals undergoing CTA during the observation period.
Measured: Day 1
Follow-up visits and referrals
The number of follow-up or referral visits, including the number of follow-up visits, number of referrals, and repeated noninvasive vascular imaging examinations (e.g., CTA, MRA, or high-resolution vessel wall MRI).
Measured: At 3-month and 12-month follow-up.
Hospitalization
Subsequent hospitalization outcomes during patient follow-up, including the rate of hospitalization, rate of hospitalization specifically related to intracranial aneurysms and the length of hospital stay.
Measured: At 3-month and 12-month follow-up.
Invasive DSA examinations
Rate of patients undergoing digital subtraction angiography (DSA), along with the distribution of findings, including positive identification of aneurysms, other vascular abnormalities, or no detectable abnormalities.
Measured: At 3-month and 12-month follow-up.
Aneurysm treatment decisions
Distribution of aneurysm management strategies, including conservative treatment, endovascular coiling, surgical clipping, and other approaches.
Measured: At 3-month and 12-month follow-up.
Intraoperative complications
The rate of aneurysm treatment-related complications-such as intraoperative rupture, , vasospasm, neurological injury, and other adverse events.
Measured: At 3-month and 12-month follow-up.
Postoperative complications
Postoperative complications, including cerebral edema, intracranial hematoma, hydrocephalus, and recurrent thrombosis.
Measured: At 3-month and 12-month follow-up.
In-hospital morbidity
In-hospital morbidity, defined as a Modified Rankin Scale (mRS) score of 3-5 at hospital discharge. The Modified Rankin Scale ranges from 0 to 6, with higher scores indicating greater disability (scores of 3-5) or death (score of 6).
Measured: At 3-month and 12-month follow-up.
In-hospital mortality
In-hospital mortality, defined as a Modified Rankin Scale (mRS) score of 6 at hospital discharge. The Modified Rankin Scale ranges from 0 to 6, with a score of 6 indicating death.
Measured: At 3-month and 12-month follow-up.
All-cause mortality
All-cause mortality during patient follow-up.
Measured: At 3-month and 12-month follow-up.
Aneurysm-related events during follow-up
Proportion of patients with aneurysm-related events during follow-up, including aneurysm growth (≥1 mm in any dimension), aneurysm rupture (non-traumatic subarachnoid hemorrhage), stroke (hemorrhagic or ischemic), de novo aneurysm formation, and aneurysm recurrence after treatment.
Measured: At 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start9 Oct 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang longjiang,MD, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124624
- Sponsor's protocol ID
- 2025DZKY-087-01
- Acronym
- IDEAL2
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an AI-Driven CT Angiography Model on Intracranial Aneurysm Detection and Clinical Outcomes in Regional Hospitals (IDEAL2): A Nationwide Stepped-Wedge Cluster-Randomized Trial
- ClinicalTrials.gov ID
- NCT07124624
- Acronym / sponsor ID
- IDEAL2 / 2025DZKY-087-01
- Conditions
- Intracranial Aneurysm, CT Angiography, AI (Artificial Intelligence), Cluster Randomized Trial
- Keywords
- Intracranial aneurysm, AI (Artificial Intelligence), Stepped-wedge cluster-randomized trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14,400 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 9 Oct 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 15 Aug 2025 (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 (IDEAL 2) is a nationwide stepped-wedge cluster-randomized trial designed to prospectively enroll over 14,400 patients undergoing outpatient head CT angiography (CTA). The trial will be conducted across more than 72 regional hospitals in China. Clusters were randomly assigned to nine randomization groups. In accordance with the stepped-wedge design, clusters will sequentially transition from the control condition (standard human diagnosis) to the intervention condition (AI-assisted diagnosis) at regular intervals over a 10-month period, until all clusters receive the intervention. The primary outcome is the detection rate of intracranial aneurysms. Secondary outcomes include patient prognosis and clinical outcomes.
Detailed description
A multicenter, stepped-wedge cluster-randomized trial will be conducted in regional hospitals, specifically prefecture-level and county-level institutions across China. Each cluster (i.e., hospital) will enroll approximately 200 patients undergoing head computed tomography angiography (CTA), yielding a total sample size of at least 14,400 participants. The trial consists of nine steps, each lasting one month. Clusters will transition sequentially from the control condition to the intervention condition based on stratified randomization, until all clusters have received the intervention.
In the control group, diagnoses and treatments will follow local standard clinical protocols. In the intervention group, diagnostic procedures will be supported by an artificial intelligence (AI)-assisted system. The primary outcome is the detection rate of intracranial aneurysms, as determined from radiology reports at the patient level. Secondary outcomes include additional diagnostic performance metrics on CTA, such as the detection of intracranial arterial stenosis, occlusion, and tumors.
Follow-up evaluations at 3 and 12 months will assess treatment-related indicators-including repeat head CTA or magnetic resonance angiography (MRA), hospitalization rates, and digital subtraction angiography (DSA) utilization-as well as clinical outcomes related to aneurysm events. These measures aim to evaluate both the short- and long-term impacts of AI-assisted diagnosis on routine clinical practice and patient prognosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Diagnosis | Experimental | Device: AI-Assisted CTA InterpretationPatients in this group will undergo head CTA, interpreted by radiologists with the assistance of a previously validated deep learning AI model. The model highlights suspected aneurysm candidates on the CTA images to support diagnostic decision-making. |
| Standard Diagnosis | Active comparator | Diagnostic Test: Standard CTA InterpretationPatients in this group will undergo head CTA, which will be interpreted by radiologists following standard local diagnostic protocols. No AI assistance will be provided during image interpretation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients in the outpatient setting who are scheduled to undergo head CTA scanning
Key exclusion criteria (6 listed)
- Age < 18 years
- History of cerebrovascular surgery involving any metallic implants (e.g., aneurysm embolization, aneurysm clipping, or vascular stenting)
- Modified Rankin Scale (mRS) score > 3
- Refuse to sign written informed consent
- Contraindications to CTA examination
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 |
|---|---|---|
| AI-Assisted CTA InterpretationA locked, independently validated deep learning model was used to assist radiologists in interpreting head CTA scans. The model was trained on 16,546 CTA cases and externally validated on an independent set of 900 DSA-verified CTA cases, achieving a patient-level sensitivity of 0.943 and an average of 0.187 false positives per case. | Device | AI-Assisted Diagnosis |
| Standard CTA InterpretationHead CTA interpretation performed by radiologists using local routine diagnostic workflows without AI support. | Diagnostic test | Standard Diagnosis |
Primary outcome
Detection rate of intracranial aneurysms
Time frame: Day 1
The proportion of patients diagnosed with intracranial aneurysms among all individuals undergoing CTA during the observation period. This outcome is used to compare the diagnostic effectiveness of conventional radiologist interpretation based on local clinical practice versus AI-assisted diagnosis in detecting intracranial aneurysms.
11 secondary outcomes
Detection rates of other intracranial lesions except aneurysms
Time frame: Day 1
Follow-up visits and referrals
Time frame: At 3-month and 12-month follow-up.
Hospitalization
Time frame: At 3-month and 12-month follow-up.
Invasive DSA examinations
Time frame: At 3-month and 12-month follow-up.
Aneurysm treatment decisions
Time frame: At 3-month and 12-month follow-up.
Intraoperative complications
Time frame: At 3-month and 12-month follow-up.
Postoperative complications
Time frame: At 3-month and 12-month follow-up.
In-hospital morbidity
Time frame: At 3-month and 12-month follow-up.
In-hospital mortality
Time frame: At 3-month and 12-month follow-up.
All-cause mortality
Time frame: At 3-month and 12-month follow-up.
Aneurysm-related events during follow-up
Time frame: At 12-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Assisted CTA Interpretation and Standard CTA Interpretation in people with Intracranial Aneurysm and CT Angiography, run by Jinling Hospital, China.
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 1 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: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Longjiang Zhang, Ph.D, MD (+8613405833176, kevinzhlj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of intracranial aneurysms (time frame: Day 1). 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 20 Aug 2025.