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

Launched by BEIJING TIANTAN HOSPITAL · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a special software designed to help doctors assess and plan for surgery in patients with non-ruptured intracranial aneurysms, which are bulges in blood vessels in the brain. The goal is to see how effective and safe this software is compared to traditional methods used by experienced surgeons. The study is being conducted at multiple medical centers and will analyze past cases to ensure a thorough and unbiased evaluation.

To participate in this trial, you must be between 18 and 80 years old and have a specific type of aneurysm that meets certain criteria, such as being between 3mm and 10mm in diameter and having a regular shape. The study is open to all genders. If eligible, participants can expect their past medical images to be reviewed using the software to help plan their treatment. It's important to know that the trial excludes individuals with certain complications, like previous bleeding in the brain or specific types of aneurysms. Overall, this research aims to improve surgical planning and outcomes for patients with intracranial aneurysms.

Gender

ALL

Eligibility criteria

• 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.

Trial Officials