Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization
Safety and Effectiveness of Intelligent Microcatheter Shaping Simulation Technology in Coil Embolization of Intracranial Aneurysms: A Prospective, Multicenter, Observational, Real-World Registry Study
1 other identifier
observational
1,438
1 country
1
Brief Summary
This prospective, multicenter, observational registry study will evaluate the real-world safety, effectiveness, and clinical value of artificial intelligence (AI)-assisted microcatheter shaping during coil embolization of intracranial aneurysms. Adults with an intracranial aneurysm who are scheduled to undergo coil embolization will be enrolled and followed for approximately 12 months. The study will not assign participants to a treatment strategy. All treatment decisions will be made by the treating physicians according to routine clinical practice. Participants will be analyzed according to whether microcatheter shaping is performed based on the physician's experience alone or with assistance from an intelligent microcatheter shaping simulation technology. The study will evaluate major adverse events within 12 months, immediate aneurysm occlusion after the procedure, clinical and quality-of-life outcomes, follow-up imaging findings, serious adverse events, repeat treatment or rehospitalization, microcatheter delivery performance, and health care resource use. At least 1,438 participants are planned to be enrolled.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2026
Typical duration 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
July 28, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedFirst Posted
Study publicly available on registry
August 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
August 6, 2026
August 1, 2026
3.3 years
July 28, 2026
August 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Major Adverse Events Within 12 Months
Percentage of participants who experience at least one major adverse event from the index coil embolization procedure through 12 months. A major adverse event is defined as neurological death or major ischemic or hemorrhagic stroke. Major stroke is defined as an increase of at least 4 points on the National Institutes of Health Stroke Scale.
From the index procedure through 12 months after the procedure
Immediate Adequate Occlusion of the Target Aneurysm
Percentage of participants whose treated target aneurysm is classified as Raymond grade I or II on angiographic assessment immediately after coil embolization.
Immediately after coil embolization on the day of the procedure
Secondary Outcomes (15)
Modified Rankin Scale Score
At hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure
EQ-5D-5L Health Utility Index
At baseline, hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure
EQ Visual Analog Scale Score
At baseline, hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure
Incidence of Procedure-Related Serious Adverse Events
From the index procedure through 12 months after the procedure
Incidence of Neurological Events
From the index procedure through 12 months after the procedure
- +10 more secondary outcomes
Study Arms (2)
Physician-Experience Cohort
Participants undergoing coil embolization of an intracranial aneurysm in whom microcatheter shaping is performed according to the treating physician's experience, without assistance from the intelligent microcatheter shaping simulation technology.
AI-Assisted Cohort
Participants undergoing coil embolization of an intracranial aneurysm in whom microcatheter shaping is performed with assistance from the intelligent microcatheter shaping simulation technology.
Interventions
Microcatheter shaping is planned and performed by the treating physician according to clinical experience without assistance from the intelligent microcatheter shaping simulation technology. The shaping approach is determined during routine clinical care and is not assigned by the study protocol.
An artificial intelligence-based decision-support technology that analyzes three-dimensional cerebrovascular anatomy, assists with aneurysm localization and measurement, and provides a suggested microcatheter shaping plan for intracranial aneurysm coil embolization. Use of the technology is determined by routine clinical practice and is not assigned by the study protocol.
Eligibility Criteria
The study population will include adults with an intracranial aneurysm confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography who are scheduled to undergo coil embolization at participating study centers. Eligible patients will be enrolled prospectively after providing written informed consent. Participants will be classified into the physician-experience cohort or the AI-assisted cohort according to whether intelligent microcatheter shaping simulation technology is used during routine clinical care. Treatment strategy and use of the technology will not be assigned by the study protocol.
You may qualify if:
- Age 18 years or older, with no restriction based on sex.
- Diagnosis of an intracranial aneurysm confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography, with the target aneurysm planned for treatment by coil embolization.
- Ability to understand the study requirements and treatment procedures and provision of written informed consent before any study-specific procedure.
You may not qualify if:
- Currently unable or expected to be unable to complete the 1-year follow-up.
- Participation in another clinical study that may affect the results of this study.
- Life expectancy of less than 1 year because of another disease or medical condition.
- Considered unsuitable for participation by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xuanwu Hospital, Beijinglead
- Union Strong（Beijing）Technology Co.Ltd.collaborator
- Qilu Hospital of Shandong Universitycollaborator
- Linyi People's Hospitalcollaborator
- Shandong Provincial Hospitalcollaborator
- Tengzhou Central People's Hospitalcollaborator
- The Second Qilu Hospital of Shandong Universitycollaborator
- Qingdao Municipal Hospitalcollaborator
- The General Hospital of the PLA Northern Theater Commandcollaborator
- Central Hospital Affiliated to Shenyang Medical Collagecollaborator
- Shenyang Sujiatun District Central Hospitalcollaborator
- Northeast International Hospitalcollaborator
- First Hospital of China Medical Universitycollaborator
- Affiliated Zhongshan Hospital of Dalian Universitycollaborator
- Panjin Liaoyou Gem Flower Hospitalcollaborator
- Beijing Tiantan Hospitalcollaborator
- Beijing Chao Yang Hospitalcollaborator
- Chinese PLA General Hospitalcollaborator
- Aerospace Center Hospitalcollaborator
- Beijing Anzhen Hospitalcollaborator
- Peking University Third Hospitalcollaborator
- Seventh Medical Center of PLA Army General Hospitalcollaborator
- Peking University International Hospitalcollaborator
- Peking University First Hospitalcollaborator
- Beijing Haidian Hospitalcollaborator
- Beijing Tsinghua Changgeng Hospitalcollaborator
- Beijing Hospitalcollaborator
- Civil Aviation General Hospitalcollaborator
Study Sites (1)
Xuanwu Hospital
Beijing, 100053, China
Related Publications (1)
Yang H, Ni W, Xu L, Geng J, He X, Ba H, Yu J, Qin L, Yin Y, Huang Y, Zhang H, Gu Y. Computer-assisted microcatheter shaping for intracranial aneurysm embolization: evaluation of safety and efficacy in a multicenter randomized controlled trial. J Neurointerv Surg. 2024 Jan 12;16(2):177-182. doi: 10.1136/jnis-2023-020104.
PMID: 37080769BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongqi Zhang
Xuanwu Hospital, Beijing
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2026
First Posted
August 6, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
August 6, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be publicly shared because the study involves multicenter clinical and imaging data containing potentially sensitive health information. The data will be used only for the purposes specified in the study protocol and will be managed in accordance with participant consent, institutional policies, ethics committee requirements, and applicable data protection regulations. De-identified aggregate results may be reported in scientific publications.