Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization

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.

Inclusion Criteria: 1. Age 18 years or older, with no restriction based on sex. 2. 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. 3. Ability to understand the study requirements and treatment procedures and provision of written informed consent before any study-specific procedure. Exclusion Criteria: 1. Currently unable or expected to be unable to complete the 1-year follow-up. 2. Participation in another clinical study that may affect the results of this study. 3. Life expectancy of less than 1 year because of another disease or medical condition. 4. Considered unsuitable for participation by the investigator.