Clinical trial NCT05651425: A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment
Official title: A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Aneurysm
Keywords: intracranial aneurysm
intravascular coiling embolization
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Shanxi Provincial People's Hospital
First posted: 2022-12-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese

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.


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.

Primary outcomes:
measure: concordance rate
timeFrame: accessment time point : immediately after computational coiling diameter assessment finished.
Secondary outcomes:
measure: coincidence rate
timeFrame: accessment time point: immediately after computational coiling diameter assessment finished.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Shuo Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: