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Enrolling by Invitation

NCT Number: NCT06364293

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Observational design does not include interventional behavior.

Other

Observational design does not include interventional behavior.

Primary outcomes

  1. Unfavorable imaging outcome

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

    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.)

Secondary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

An Early Warning Model of Unfavorable Outcomes Following Endovascular Interventional Treatment of Intracranial Aneurysms Based on Medical Image Analysis and Deep Learning Algorithm

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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