Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization

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.

Conditions

• Intracranial Aneurysm

Interventions

PROCEDURE

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.

DEVICE

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.

Sponsors & Collaborators

• Union Strong（Beijing）Technology Co.Ltd.

  collaborator UNKNOWN

• Qilu Hospital of Shandong University

  collaborator OTHER

• Linyi People's Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Tengzhou Central People's Hospital

  collaborator OTHER_GOV

• The Second Qilu Hospital of Shandong University

  collaborator UNKNOWN

• Qingdao Municipal Hospital

  collaborator OTHER

• The General Hospital of the PLA Northern Theater Command

  collaborator UNKNOWN

• Central Hospital Affiliated to Shenyang Medical Collage

  collaborator OTHER

• Shenyang Sujiatun District Central Hospital

  collaborator UNKNOWN

• Northeast International Hospital

  collaborator UNKNOWN

• First Hospital of China Medical University

  collaborator OTHER

• Affiliated Zhongshan Hospital of Dalian University

  collaborator OTHER

• Panjin Liaoyou Gem Flower Hospital

  collaborator UNKNOWN

• Beijing Tiantan Hospital

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Aerospace Center Hospital

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Seventh Medical Center of PLA Army General Hospital

  collaborator OTHER

• Peking University International Hospital

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Beijing Haidian Hospital

  collaborator OTHER

• Beijing Tsinghua Changgeng Hospital

  collaborator OTHER

• Beijing Hospital

  collaborator OTHER_GOV

• Civil Aviation General Hospital

  collaborator OTHER

• Xuanwu Hospital, Beijing

  lead OTHER

Principal Investigators

• Hongqi Zhang · Xuanwu Hospital, Beijing

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• China

Study Locations