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

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Shuo Wang, MD; Phone Number: 13801180330; Email: captain5868@162.com
• Study Contact Backup: Name: Qinyuan Liu, MD; Phone Number: 13260457220; Email: 13260457220@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Qingyuan Liu, MD; Phone Number: 13260457220; Email: 13260457220@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chinese

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
surgeon-independent group; the coiling diameter is predicted by experienced surgeon alone.
surgeon-software-assistant group; the coiling diameter is predicted by experienced surgeon with software assistant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concordance rate	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%	accessment time point : immediately after computational coiling diameter assessment finished.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
coincidence rate	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%	accessment time point: immediately after computational coiling diameter assessment finished.

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: RenJi Hospital; Shanxi Provincial People's Hospital
• Investigators: Principal Investigator: Shuo Wang, MD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2022
• Primary Completion (Anticipated): January 20, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Estimate): December 15, 2022

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: intracranial aneurysm; intravascular coiling embolization
• 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: QX2022-011-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No