Intracranial AneurysmNCT07749404
Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization
An observational study of Intracranial Aneurysm, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Physician-Experience Microcatheter Shaping and AI-Assisted Microcatheter Shaping Simulation Technology
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1,438 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to Dec 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital
Beijing, 100053
Xin Su, +8618210685023, 1258940078@qq.com
Yongjie Ma, M.D, mayongjiexuanwu@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Intracranial Aneurysm
- Being tested
- Physician-Experience Microcatheter Shaping, AI-Assisted Microcatheter Shaping Simulation Technology
- Keywords
- Artificial Intelligence, Computer-Assisted Microcatheter Shaping, Microcatheter Shaping, Coil Embolization, Endovascular Treatment, Intracranial Aneurysm, Real-World Registry, Medical Device, Neurointervention
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-Experience Microcatheter ShapingProcedure or surgery
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 Microcatheter Shaping Simulation TechnologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Physician-Experience Microcatheter Shaping | |
| 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. Receives: Device: AI-Assisted Microcatheter Shaping Simulation Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after coil embolization on the day of the procedure
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the index procedure through 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,438 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Hongqi Zhang, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749404
- Sponsor's protocol ID
- xwzhqmayongjiesxwsmhyf
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 37080769
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Intelligent Microcatheter Shaping Simulation Technology in Coil Embolization of Intracranial Aneurysms: A Prospective, Multicenter, Observational, Real-World Registry Study
- ClinicalTrials.gov ID
- NCT07749404
- Acronym / sponsor ID
- xwzhqmayongjiesxwsmhyf
- Conditions
- Intracranial Aneurysm
- Keywords
- Artificial Intelligence, Computer-Assisted Microcatheter Shaping, Microcatheter Shaping, Coil Embolization, Endovascular Treatment, Intracranial Aneurysm, Real-World Registry, Medical Device
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,438 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- 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
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physician-Experience Cohort | – | Procedure: Physician-Experience Microcatheter ShapingParticipants 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. |
| AI-Assisted Cohort | – | Device: AI-Assisted Microcatheter Shaping Simulation TechnologyParticipants undergoing coil embolization of an intracranial aneurysm in whom microcatheter shaping is performed with assistance from the intelligent microcatheter shaping simulation technology. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician-Experience Microcatheter ShapingMicrocatheter 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. | Procedure or surgery | Physician-Experience Cohort |
| AI-Assisted Microcatheter Shaping Simulation TechnologyAn 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. | Device | AI-Assisted Cohort |
Primary outcome
Incidence of Major Adverse Events Within 12 Months
Time frame: 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
Time frame: 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.
15 secondary outcomes
Modified Rankin Scale Score
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 procedure
EQ-5D-5L Health Utility Index
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 procedure
EQ Visual Analog Scale Score
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 procedure
Incidence of Procedure-Related Serious Adverse Events
Time frame: From the index procedure through 12 months after the procedure
Incidence of Neurological Events
Time frame: From the index procedure through 12 months after the procedure
Incidence of Target Aneurysm Reintervention or Rehospitalization
Time frame: From hospital discharge through 12 months after the procedure
Length of Index Hospital Stay
Time frame: At hospital discharge, up to 30 days after admission for the index procedure.
Cumulative Treatment-Related Costs
Time frame: From the index hospitalization through 12 months after the procedure
Adequate Occlusion of the Target Aneurysm During Follow-Up
Time frame: At 180 days (±30 days) and 360 days (±45 days) after the procedure
Incidence of Greater Than 50 Percent Parent Artery Stenosis
Time frame: At 180 days (±30 days) and 360 days (±45 days) after the procedure
Microcatheter Delivery Time
Time frame: During the index coil embolization procedure
Number of Microcatheter Delivery Attempts
Time frame: During the index coil embolization procedure
Number of Microcatheter Shaping Attempts
Time frame: During the index coil embolization procedure
Incidence of Microcatheter Instability
Time frame: During the index coil embolization procedure
Incidence of Device-Related Serious Adverse Events
Time frame: From the index procedure through 12 months after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 37080769Yang 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongqi Zhang principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongqi Zhang, M.D (+8613601374152, xwzhanghq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Events Within 12 Months (time frame: From the index procedure through 12 months after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07749404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.