Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Incidence of Major Adverse Events Within 12 Months — From the index procedure through 12 months after the procedure
  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.
• Immediate Adequate Occlusion of the Target Aneurysm — Immediately after coil embolization on the day of the procedure
  Percentage of participants whose treated target aneurysm is classified as Raymond grade I or II on angiographic assessment immediately after coil embolization.

Trial sites (1)

More Xuanwu Hospital, Beijing trials in China

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