Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization

Safety and Effectiveness of Intelligent Microcatheter Shaping Simulation Technology in Coil Embolization of Intracranial Aneurysms: A Prospective, Multicenter, Observational, Real-World Registry Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Procedure: Physician-Experience Microcatheter Shaping; Device: AI-Assisted Microcatheter Shaping Simulation Technology

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.

• Study Type: Observational
• Enrollment (Estimated): 1438

Contacts and Locations

• Study Contact: Name: Hongqi Zhang, M.D; Phone Number: +8613601374152; Email: xwzhanghq@163.com
• Study Contact Backup: Name: Xin Su, M.D; Phone Number: +8618210685023; Email: 1258940078@qq.com

Study Locations

• China
  • Beijing, China, 100053
    • Xuanwu Hospital
    • Contact: Xin Su; Phone Number: +8618210685023; Email: 1258940078@qq.com
    • Contact: Yongjie Ma, M.D; Email: mayongjiexuanwu@163.com
    • Sub-Investigator: Yongjie Ma, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Physician-Experience Cohort; Participants undergoing coil embolization of an intracranial aneurysm in whom microcatheter shaping is performed according to the treating physician's experience, without assistance from the intelligent microcatheter shaping simulation technology.	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.
AI-Assisted Cohort; Participants undergoing coil embolization of an intracranial aneurysm in whom microcatheter shaping is performed with assistance from the intelligent microcatheter shaping simulation technology.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the index procedure through 12 months after the procedure
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.	Immediately after coil embolization on the day of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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
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.	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
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.	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
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.	From the index procedure through 12 months after the procedure
Incidence of Neurological Events	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.	From the index procedure through 12 months after the procedure
Incidence of Target Aneurysm Reintervention or Rehospitalization	Percentage of participants who undergo repeat treatment of the target aneurysm or are rehospitalized after the index coil embolization procedure.	From hospital discharge through 12 months after the procedure
Length of Index Hospital Stay	Number of days from admission for the index coil embolization procedure to hospital discharge.	At hospital discharge, up to 30 days after admission for the index procedure.
Cumulative Treatment-Related Costs	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.	From the index hospitalization through 12 months after the procedure
Adequate Occlusion of the Target Aneurysm During Follow-Up	Percentage of participants whose treated target aneurysm is classified as Raymond grade I or II on follow-up vascular imaging.	At 180 days (±30 days) and 360 days (±45 days) after the procedure
Incidence of Greater Than 50 Percent Parent Artery Stenosis	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.	At 180 days (±30 days) and 360 days (±45 days) after the procedure
Microcatheter Delivery Time	Time required to deliver the microcatheter to the intended position for coil embolization, recorded in hours, minutes, and seconds.	During the index coil embolization procedure
Number of Microcatheter Delivery Attempts	Number of attempts required to deliver the microcatheter to the intended position, categorized as 1, 2, 3, or more than 3 attempts.	During the index coil embolization procedure
Number of Microcatheter Shaping Attempts	Number of microcatheter shaping attempts required during the procedure, categorized as 1, 2, 3, or more than 3 attempts.	During the index coil embolization procedure
Incidence of Microcatheter Instability	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.	During the index coil embolization procedure
Incidence of Device-Related Serious Adverse Events	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.	From the index procedure through 12 months after the procedure

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Peking University First Hospital; Beijing Tiantan Hospital; Chinese PLA General Hospital; Peking University Third Hospital; Qilu Hospital of Shandong University; Peking University International Hospital; Shandong Provincial Hospital; Beijing Chao Yang Hospital; Beijing Hospital; Qingdao Municipal Hospital; Beijing Anzhen Hospital; First Hospital of China Medical University; Beijing Haidian Hospital; Tengzhou Central People's Hospital; Panjin Liaoyou Gem Flower Hospital; Beijing Tsinghua Changgeng Hospital; Linyi People's Hospital; Civil Aviation General Hospital; Seventh Medical Center of PLA Army General Hospital; Aerospace Center Hospital; Central Hospital Affiliated to Shenyang Medical Collage; Affiliated Zhongshan Hospital of Dalian University; Union Strong（Beijing）Technology Co.Ltd.; The Second Qilu Hospital of Shandong University; The General Hospital of the PLA Northern Theater Command; Shenyang Sujiatun District Central Hospital; Northeast International Hospital
• Investigators: Principal Investigator: Hongqi Zhang, Xuanwu Hospital, Beijing

Publications and helpful links

General Publications

• Yang H, Ni W, Xu L, Geng J, He X, Ba H, Yu J, Qin L, Yin Y, Huang Y, Zhang H, Gu Y. Computer-assisted microcatheter shaping for intracranial aneurysm embolization: evaluation of safety and efficacy in a multicenter randomized controlled trial. J Neurointerv Surg. 2024 Jan 12;16(2):177-182. doi: 10.1136/jnis-2023-020104.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: July 28, 2026
• First Submitted That Met QC Criteria: August 2, 2026
• First Posted (Actual): August 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 2, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Medical Device; Intracranial Aneurysm; Endovascular Treatment; Neurointervention; Coil Embolization; Computer-Assisted Microcatheter Shaping; Microcatheter Shaping; Real-World Registry
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: xwzhqmayongjiesxwsmhyf

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared because the study involves multicenter clinical and imaging data containing potentially sensitive health information. The data will be used only for the purposes specified in the study protocol and will be managed in accordance with participant consent, institutional policies, ethics committee requirements, and applicable data protection regulations. De-identified aggregate results may be reported in scientific publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No