Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization
ConditionIntracranial Aneurysm
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorXuanwu Hospital, Beijing
About this trial
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 criteria
Qualifiers
Age 18 years or older, with no restriction based on sex.
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.
Ability to understand the study requirements and treatment procedures and provision of written informed consent before any study-specific procedure.
Disqualifiers
Currently unable or expected to be unable to complete the 1-year follow-up.
Participation in another clinical study that may affect the results of this study.
Life expectancy of less than 1 year because of another disease or medical condition.
Considered unsuitable for participation by the investigator.
Trial design
Treatments tested in this trial
- Physician-Experience Microcatheter Shaping
- AI-Assisted Microcatheter Shaping Simulation Technology
Treatment groups
1,438 Participants
are divided into 2 treatment groupsSponsors and collaborators
Xuanwu Hospital, Beijing
Lead sponsor
Union Strong（Beijing）Technology Co.Ltd.
Collaborator
Qilu Hospital of Shandong University
Collaborator
Linyi People's Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
Tengzhou Central People's Hospital
Collaborator
The Second Qilu Hospital of Shandong University
Collaborator
Qingdao Municipal Hospital
Collaborator
The General Hospital of the PLA Northern Theater Command
Collaborator
Central Hospital Affiliated to Shenyang Medical Collage
Collaborator
Shenyang Sujiatun District Central Hospital
Collaborator
Northeast International Hospital
Collaborator
First Hospital of China Medical University
Collaborator
Affiliated Zhongshan Hospital of Dalian University
Collaborator
Panjin Liaoyou Gem Flower Hospital
Collaborator
Beijing Tiantan Hospital
Collaborator
Beijing Chao Yang Hospital
Collaborator
Chinese PLA General Hospital
Collaborator
Aerospace Center Hospital
Collaborator
Beijing Anzhen Hospital
Collaborator
Peking University Third Hospital
Collaborator
Seventh Medical Center of PLA Army General Hospital
Collaborator
Peking University International Hospital
Collaborator
Peking University First Hospital
Collaborator
Beijing Haidian Hospital
Collaborator
Beijing Tsinghua Changgeng Hospital
Collaborator
Beijing Hospital
Collaborator
Civil Aviation General Hospital
Collaborator
Source ClinicalTrials.gov