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Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization
Sponsor: Xuanwu Hospital, Beijing
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.
Official title: Safety and Effectiveness of Intelligent Microcatheter Shaping Simulation Technology in Coil Embolization of Intracranial Aneurysms: A Prospective, Multicenter, Observational, Real-World Registry Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
1438
Start Date
2026-08-01
Completion Date
2029-12
Last Updated
2026-08-06
Healthy Volunteers
No
Conditions
Interventions
Physician-Experience Microcatheter Shaping
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.
AI-Assisted Microcatheter Shaping Simulation Technology
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.
Locations (1)
Xuanwu Hospital
Beijing, China