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.

NCT Number	NCT07749404
Lead Sponsor	Xuanwu Hospital, Beijing Collaborators: Union Strong（Beijing）Technology Co.Ltd., Qilu Hospital of Shandong University, Linyi People's Hospital, Shandong Provincial Hospital, Tengzhou Central People's Hospital, The Second Qilu Hospital of Shandong University, Qingdao Municipal Hospital, The General Hospital of the PLA Northern Theater Command, Central Hospital Affiliated to Shenyang Medical Collage, Shenyang Sujiatun District Central Hospital, Northeast International Hospital, First Hospital of China Medical University, Affiliated Zhongshan Hospital of Dalian University, Panjin Liaoyou Gem Flower Hospital, Beijing Tiantan Hospital, Beijing Chao Yang Hospital, Chinese PLA General Hospital, Aerospace Center Hospital, Beijing Anzhen Hospital, Peking University Third Hospital, Seventh Medical Center of PLA Army General Hospital, Peking University International Hospital, Peking University First Hospital, Beijing Haidian Hospital, Beijing Tsinghua Changgeng Hospital, Beijing Hospital, Civil Aviation General Hospital
Conditions	Intracranial Aneurysm
Enrollment	1,438 participants
Start Date	2026-08-01
Primary Completion	2029-12 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-06