A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement

Completed

• Conditions: Intracranial Aneurysm
• Interventions: Other: Observational study

• Registration Number: NCT05804474
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

the goal of this clinical trail is to evaluate the clinical efficiency of intracranial aneurysm assistive software in the morphological measurement. The trail is designed as retrospective, multicenter, controlled clinical trail. Collecting probable cases images retrospectively according to inclusion criteria and exclusion criteria strictly. Controlling bias strictly, to make sure the measurement of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, six physicions were recruited, containing three neuroradiologists, two radiologists and a residents. Software-assistant planning controls against no software-assisant planning，which aims to evaluate the improvement of morphological measurement efficiency of physicians.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2023-03
• Primary Completion: 2023-03-25
• Study Completion: 2023-03-25
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. aged 18-75y, no gender limitation.
2. non-ruptured intracranial saccular aneurysm with specific intracranial CTA images.
3. Intracranial aneurysm was not treated.

Inclusion criteria of images:

1. the number of detector rows of Computed Tomography(CT) is more than 16 rows.
2. slice thickness ≤ 0.625mm, whole-brain image is considered.
3. Both plain scan sequences and enhancer sequence are required.

Exclusion Criteria

1. combined with cerebral hemorrhage;
2. combined with cerevascular malformation or cerebral occupying lesion;
3. fusiform aneurysm or dissection aneurysm;
4. intracaverous internal carotid artery aneurysm;

Exclusion criteria of images:

1. none DICOM format;
2. quality score less than 3 scores;
3. metal artifacts existance.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Vessels	Observational study	-
Intracranial Aneurysms	Observational study	-

Primary Outcome Measures

Name	Time	Method
Intracranial aneurysm size	10 years

Secondary Outcome Measures

Name	Time	Method
Intracranial aneurysm width	10 years
Size ratio	10 years
Intracranial aneurysm volume	10 years
Intracranial aneurysm height	10 years
Parent artery diameter	10 years
Intracranial aneurysm neck diameter	10 years
Aspect ratio	10 years

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China