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
This trial does not accept healthy volunteersQualifiers
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 population
The study population will include adults with an intracranial aneurysm confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography who are scheduled to undergo coil embolization at participating study centers. Eligible patients will be enrolled prospectively after providing written informed consent. Participants will be classified into the physician-experience cohort or the AI-assisted cohort according to whether intelligent microcatheter shaping simulation technology is used during routine clinical care. Treatment strategy and use of the technology will not be assigned by the study protocol.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Physician-Experience Microcatheter Shaping
Procedure/SurgeryMicrocatheter 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
DeviceAn 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.
Treatment groups
1,438 Participants
are divided into 2 treatment groupsGroup A: Physician-Experience Cohort1 intervention
Group B: AI-Assisted Cohort1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Major Adverse Events Within 12 Months
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.
Time frame
From the index procedure through 12 months after the procedure2
Immediate Adequate Occlusion of the Target Aneurysm
Percentage of participants whose treated target aneurysm is classified as Raymond grade I or II on angiographic assessment immediately after coil embolization.
Time frame
Immediately after coil embolization on the day of the procedureSecondary outcomes
1
Modified Rankin Scale Score
Distribution of modified Rankin Scale scores. The scale ranges from 0 to 6, with 0 indicating no symptoms and 6 indicating death. Lower scores indicate better functional status.
Time frame
At hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure2
EQ-5D-5L Health Utility Index
Health-related quality of life assessed using the EQ-5D-5L questionnaire, which evaluates mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Responses will be converted to a health utility index according to the prespecified scoring method.
Time frame
At baseline, hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure3
EQ Visual Analog Scale Score
Participant-reported overall health status measured using the EQ Visual Analog Scale. Scores range from 0 to 100, with higher scores indicating better self-reported health.
Time frame
At baseline, hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure4
Incidence of Procedure-Related Serious Adverse Events
Percentage of participants who experience at least one serious adverse event considered by the investigator to be related to the coil embolization procedure.
Time frame
From the index procedure through 12 months after the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
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