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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Other: Observational design does not include interventional behavior.

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; Observational design does not include interventional behavior.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: National Natural Science Foundation of China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Deep learning; Unfavorable imaging outcome; artificial intelligent prediction model
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: KY2023-261-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No