A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment
1 other identifier
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2022
CompletedFirst Posted
Study publicly available on registry
December 15, 2022
CompletedStudy Start
First participant enrolled
December 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedDecember 15, 2022
December 1, 2022
1 month
November 23, 2022
December 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
coincidence rate
accessment time point: immediately after computational coiling diameter assessment finished.
Study Arms (2)
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.
Eligibility Criteria
Chinese
You may qualify if:
- aged 18-80y, no gender limitation.
- non-ruptured intracranial saccular aneurysm with specific intracranial CTA images; Target aneurysm has performed intravascular coiling treatment.
- intracranial aneurysm diameter range from 3mm to 10mm.
- the shape of aneurysm is regular without daughter sac or more than 2 lobulations.
- the number of detector rows of Computed Tomography(CT) is more than 16 rows.
- slice thickness ≤ 0.625mm, whole-brain image is considered.
- Both plain scan sequences and enhancer sequence are required.
You may not qualify if:
- combined with cerebral hemorrhage;
- combined with cerevascular malformation or cerebral occupying lesion;
- fusiform aneurysm or dissection aneurysm;
- significant proximal stenosis of parent artery;
- intracaverous internal carotid artery aneurysm;
- target aneurysm has been performed flow-diverter stents treatment.
- none DICOM format;
- quality score less than 3 scores;
- metal artifacts existance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Tiantan Hospitallead
- RenJi Hospitalcollaborator
- Shanxi Provincial People's Hospitalcollaborator
Study Sites (1)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Biospecimen
Clinical data of all patients enrolled in our trial are preserved in CRF format, and CTA data are preserved in DICOM format.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shuo Wang, MD
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Cerebrovascular Neurosurgery
Study Record Dates
First Submitted
November 23, 2022
First Posted
December 15, 2022
Study Start
December 20, 2022
Primary Completion
January 20, 2023
Study Completion
April 30, 2023
Last Updated
December 15, 2022
Record last verified: 2022-12