Intracranial Aneurysm
Conditions
Keywords
Artificial Intelligence, Computer-Assisted Microcatheter Shaping, Microcatheter Shaping, Coil Embolization, Endovascular Treatment, Intracranial Aneurysm, Real-World Registry, Medical Device, Neurointervention
Brief 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.
Detailed description
Microcatheter shaping is an important technical step in the endovascular coil embolization of intracranial aneurysms. The shape and stability of the microcatheter may affect access to the aneurysm, coil delivery, procedural efficiency, and procedural safety. The AI-assisted microcatheter shaping simulation technology evaluated in this study analyzes three-dimensional cerebrovascular anatomy to assist with aneurysm localization and measurement and to generate a suggested microcatheter shaping plan. The technology provides decision support, while the treating physician remains responsible for all clinical decisions. This is a prospective, multicenter, observational, real-world registry study. Adult patients with an intracranial aneurysm confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography and scheduled to undergo coil embolization may be enrolled after providing written informed consent. Participants will not be randomly assigned to a treatment group, and participation in the registry will not determine the treatment received. For analysis, participants will be classified into two observational cohorts according to actual clinical practice. In the physician-experience cohort, microcatheter shaping is performed according to the treating physician's experience. In the AI-assisted cohort, microcatheter shaping is performed with support from the intelligent microcatheter shaping simulation technology. Study information will be collected during six planned visits: screening, the procedure, the postoperative hospitalization period, approximately 30 days after treatment, approximately 180 days after treatment, and approximately 360 days after treatment. Collected data will include participant characteristics, medical history, aneurysm and parent-artery morphology, procedural and device information, medication use, microcatheter delivery time and attempts, number of shaping attempts, microcatheter stability, clinical outcomes, quality of life, imaging outcomes, adverse events, serious adverse events, repeat interventions, rehospitalizations, and health care resource use. The primary safety evaluation is the occurrence of major adverse events within 12 months, 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. The primary effectiveness evaluation is immediate adequate aneurysm occlusion after coil embolization, defined as Raymond grade I or II. Because the use of AI-assisted technology is determined by routine clinical practice rather than random assignment, statistical analyses will focus on estimating differences between the two cohorts while accounting for potential confounding factors. Regression-based adjustment will be used, with propensity score methods and sensitivity analyses considered when appropriate.
Interventions
PROCEDUREPhysician-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.
DEVICEAI-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
Xuanwu Hospital, Beijing
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
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older, with no restriction based on sex. 2. 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. 3. Ability to understand the study requirements and treatment procedures and provision of written informed consent before any study-specific procedure.
Exclusion criteria
1. Currently unable or expected to be unable to complete the 1-year follow-up. 2. Participation in another clinical study that may affect the results of this study. 3. Life expectancy of less than 1 year because of another disease or medical condition. 4. Considered unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale Score | At hospital discharge or Day 7 after the procedure, 30 days (±15 days), 180 days (±30 days), and 360 days (±45 days) after the procedure | 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. |
| EQ-5D-5L Health Utility Index | 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 procedure | 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. |
| EQ Visual Analog Scale Score | 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 procedure | 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. |
| Incidence of Procedure-Related Serious Adverse Events | From the index procedure through 12 months after the procedure | Percentage of participants who experience at least one serious adverse event considered by the investigator to be related to the coil embolization procedure. |
| Incidence of Neurological Events | From the index procedure through 12 months after the procedure | Percentage of participants who experience at least one neurological event, including ischemic stroke, hemorrhagic stroke, neurological death, intracranial hemorrhage, subarachnoid hemorrhage, arterial thrombosis, perforation or rupture of the parent artery or a branch artery, or transient ischemic attack. |
| Incidence of Target Aneurysm Reintervention or Rehospitalization | From hospital discharge through 12 months after the procedure | Percentage of participants who undergo repeat treatment of the target aneurysm or are rehospitalized after the index coil embolization procedure. |
| Length of Index Hospital Stay | At hospital discharge, up to 30 days after admission for the index procedure. | Number of days from admission for the index coil embolization procedure to hospital discharge. |
| Cumulative Treatment-Related Costs | From the index hospitalization through 12 months after the procedure | Cumulative treatment-related costs in Chinese yuan, including costs of the index hospitalization, diagnostic examinations, surgical treatment, medical devices and consumables, medications, follow-up examinations, treatment of complications, direct nonmedical costs, and recorded indirect costs. |
| Adequate Occlusion of the Target Aneurysm During Follow-Up | At 180 days (±30 days) and 360 days (±45 days) after the procedure | Percentage of participants whose treated target aneurysm is classified as Raymond grade I or II on follow-up vascular imaging. |
| Incidence of Greater Than 50 Percent Parent Artery Stenosis | At 180 days (±30 days) and 360 days (±45 days) after the procedure | Percentage of participants with greater than 50 percent stenosis of the parent artery at the location of the treated target aneurysm on follow-up vascular imaging. |
| Microcatheter Delivery Time | During the index coil embolization procedure | Time required to deliver the microcatheter to the intended position for coil embolization, recorded in hours, minutes, and seconds. |
| Number of Microcatheter Delivery Attempts | During the index coil embolization procedure | Number of attempts required to deliver the microcatheter to the intended position, categorized as 1, 2, 3, or more than 3 attempts. |
| Number of Microcatheter Shaping Attempts | During the index coil embolization procedure | Number of microcatheter shaping attempts required during the procedure, categorized as 1, 2, 3, or more than 3 attempts. |
| Incidence of Microcatheter Instability | During the index coil embolization procedure | Percentage of participants in whom microcatheter kickback or displacement occurs during coil embolization. Microcatheter instability is recorded as a binary outcome of yes or no. |
| Incidence of Device-Related Serious Adverse Events | From the index procedure through 12 months after the procedure | Percentage of participants who experience at least one serious adverse event considered by the investigator to be related to a device used during the coil embolization procedure, including the intelligent microcatheter shaping simulation technology when applicable. |
Countries
China
Contacts
CONTACTHongqi Zhang, M.D
CONTACTXin Su, M.D
PRINCIPAL_INVESTIGATORHongqi Zhang
Xuanwu Hospital, Beijing
Outcome results
None listed