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

Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651425
• Other study ID #: QX2022-011-02
• Status: Recruiting
• Start date: December 20, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: December 2022
• Source: Beijing Tiantan Hospital
• Contact: Shuo Wang, MD
• Phone: 13801180330
• Email: captain5868[@]162.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 30, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	RenJi Hospital, Shanxi Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.