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Enrolling by invitationNCT06364293Updated Apr 15, 2024

An Early Warning Model of Unfavorable Outcomes Following Endovascular Interventional Treatment of Intracranial Aneurysm

An observational study in Intracranial Aneurysm, sponsored by Beijing Tiantan Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-15.

Sponsored by Beijing Tiantan Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
750
Ages
18 Years to 80 Years
Sex
All
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Study summary

Endovascular treatment has become one of the primary treatment methods for intracranial aneurysms. The unfavorable outcomes during follow-up included aneurysm recurrence and long-term incomplete-occlusion, which would bring a high risk of rebleeding and retreatment. Previous studies have tried to predict the outcomes of aneurysms following endovascular treatment based on aneurysm characteristics including morphology, embolization packing degree, etc, but the conclusion was inconsistent. Hemodynamics of aneurysms and parent artery played a greater role in predicting outcomes following endovascular treatments. Investigators also found that the outcomes were determined by many factors, in which the demography, clinical indicators, treatment methods, and material selection can not be ignored, and the mechanism of unfavorable imaging outcomes should be explored using large samples of clinical cases and numerous variable parameters. The pre-experiment of investigators confirmed that artificial intelligence technology can meet the calculation requirements for deep mining and analysis of large sample data. This study aims to use the deep learning model to identify relevant risk factors and weights, establish a stable and accurate prediction model, then incorporate the prospective study to verify the model. The results will be very helpful in accurately predicting the adverse outcomes such as recurrence and long-term non-occlusion after endovascular treatment and help to improve the therapeutic strategy and avoid risk factors. Besides, the occurrence of ischemic or hemorrhagic complications during follow-up may affect the final follow-up outcome, so the analysis was included as one of the outcome events to evaluate the prognosis after intervention.

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Conditions studied

  • Intracranial Aneurysm

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Keywords

  • Unfavorable imaging outcome
  • artificial intelligent prediction model
  • Deep learning
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In context

Intracranial Aneurysm

429 studies on the registry are indexed under Intracranial Aneurysm; 114 are open to participants now.

This study's planned enrollment of 750 is above the median of 200 across 199 observational studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 481 studies on the registry; 287 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This study included the patients undergoing intravascular interventional treatment of intracranial aneurysms.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of intracranial aneurysm;
  • Endovascular intervention was performed;
  • The age is more than 18 years and less than 80 years;
  • At least one follow-up of imaging data must be digital subtraction angiography with a time interval of 12 months or more;
  • The quality of image data can satisfy morphological measurement and hemodynamic calculation;
  • The patient family members were informed and consented to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Dynamic aneurysms with cerebrovascular malformation;
  • Dissecting, fusiform or thrombotic aneurysms;
  • Follow-up images were not digital subtraction angiography or data quality can not meet the hydrodynamic analysis.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
750 participants (estimated)
Patient registry
No

Groups and cohorts

  • the cohort with or without unfavorable imaging outcome

    Cohorts will be divided into the favorable imaging outcome group and unfavorable imaging outcome group according to the interpretation of the imaging outcome of the postoperative follow-up of intravascular interventional therapy for intracranial aneurysms

    Other: Observational design does not include interventional behavior.

Interventions

  • OtherObservational design does not include interventional behavior.

    Observational design does not include interventional behavior.

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What researchers measure

Primary outcomes

  1. Unfavorable imaging outcome

    Unfavorable imaging outcome included the recurrence and long-term incomplete aneurysm occlusion. Any enlarged imaging of the residual portion of the aneurysm is considered a recurrence compared to immediate postoperative imaging. At the last DSA follow-up longer than 12 months, the aneurysm was not completely occluded, showing aneurysm residual portion and development (Raymond scale 3) and was judged to be long-term incomplete aneurysm occlusion.)

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Hemorrhagic or ischemic complication occurred during the follow-up

    Ischemic or hemorrhagic complications occurred in patients with intracranial aneurysms during follow-up after endovascular therapy

    Time frame: through study completion, an average of 1 year

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Study locations

1 site
  • Beijing Tiantan hospital
    Beijing, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06364293
Collaborators
National Natural Science Foundation of China
Responsible party
Sponsor
First posted
Apr 15, 2024
Start date
Jan 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 15, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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