Intracranial Aneurysm
Conditions
Interventions
Internal retrospective independent test cohort:None
External Centre 1 retrospective independent test cohort:None
External Centre 2 retrospective independent test cohort:None
Internal silent prospective validation cohort:None
External Centre 1 silent prospective validation cohort:None
AI-first crossover reader group:Readers will complete procedural planning for all locked cases with artificial intelligence assistance during the first reading period. After a washout period of 28+/-3
Unaided-first crossover reader group:Readers will complete procedural planning for all locked cases without artificial intelligence assistance during the first reading period. After a washout period o
Sponsors
Medical Ethics Committee of the General Hospital of the Northern Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 years or older. 2.A confirmed diagnosis of intracranial aneurysm based on clinical and imaging examinations. 3.Availability of three-dimensional digital subtraction angiography data that meet the input and analytical requirements of the artificial intelligence system. 4.The rupture status of the target aneurysm at the current presentation can be reliably determined. 5.The patient has undergone or is scheduled to undergo coil embolization for the intracranial aneurysm. 6.Information regarding stent use and the specifications of the first framing coil is available from procedural planning or actual treatment records. 7.Clinical, imaging and procedural data can be reliably matched to the target aneurysm. 8.The collection and use of study data are covered by the scope of the relevant ethics approval. 9.For patients with multiple intracranial aneurysms, the target aneurysm for the current treatment can be prespecified before analysis or reader assessment.
Exclusion criteria
Exclusion criteria: 1.Digital subtraction angiography images contain severe artefacts, lack critical image sections, or cannot be reconstructed into a three-dimensional dataset that meets the study requirements. 2.The target aneurysm has previously undergone surgical or endovascular treatment resulting in substantial morphological alteration outside the prespecified study scope. 3.The target aneurysm cannot be reliably matched with its rupture status, clinical data or procedural records. 4.Key procedural information, including stent use or the diameter of the first framing coil, is missing and cannot be verified from the source records. 5.Critical imaging or clinical information required for the primary study tasks is unavailable. 6.The collection or use of the case data is outside the scope of the ethics approval, informed consent or applicable data-use requirements. 7.Any inclusion criterion is not fulfilled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concordance rate of stent-assistance recommendations with the expert reference standard;Proportion of recommended first framing-coil diameters within the expert-defined acceptable range; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dice similarity coefficient for automated intracranial aneurysm segmentation;Area under the receiver operating characteristic curve for classification of intracranial aneurysm rupture status at presentation; | — |
Countries
China
Contacts
Public ContactHai Jin
The General Hospital of Northern Theater Command
Outcome results
None listed