A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment

Recruiting

• Conditions: Intracranial Aneurysm

• Registration Number: NCT05651425
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

the goal of this clinical trail is to evaluate the efficiency and safety of intracranial aneurysm assistive software in the preoperative assessment. 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 efficiency and safety of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, software-assisstant planning controls against experienced-surgeon-independent planning，which aims to avoid bias effictively and eliminate non-test interferences.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-23
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-13
• Last Update Submitted: 2022-12-13
• Study First Posted: 2022-12-15
• Last Update Posted: 2022-12-15
• Study Start: 2022-12-20
• Primary Completion: 2023-01-20
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. aged 18-80y, no gender limitation.
2. non-ruptured intracranial saccular aneurysm with specific intracranial CTA images; Target aneurysm has performed intravascular coiling treatment.
3. intracranial aneurysm diameter range from 3mm to 10mm.
4. the shape of aneurysm is regular without daughter sac or more than 2 lobulations.

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. significant proximal stenosis of parent artery;
5. intracaverous internal carotid artery aneurysm;
6. target aneurysm has been performed flow-diverter stents treatment.

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

Primary Outcome Measures

Name	Time	Method
concordance rate	accessment time point : immediately after computational coiling diameter assessment finished.	the optimal coiling diameter used in surgery is considered as "gold standard". The concordance rate is defined as computational suitable coiling diameter in test group differs gold standard less than ±1mm.; concordance rate=the number of concordance matched/totle enrolled number\*100%

Secondary Outcome Measures

Name	Time	Method
coincidence rate	accessment time point: immediately after computational coiling diameter assessment finished.	the optimal coiling diameter used in surgery is considered as "gold standard". The coincidence rate is defined as computational suitable coiling diameter in test group is less than gold standard.; coincidence rate= the number meets coincidence requirement /totle enrolled \*100%

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China