Intracranial AneurysmWEB-RWSNCT07620626
Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment
An observational study of Intracranial Aneurysm, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
We designed the Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS), an ambidirectional, multicenter, post-market real-world study with a prospective active surveillance component. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Intrasaccular Flow Disruption Device
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 30 Jun 2028
- 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 includes patients with intracranial aneurysms who are treated with the commercially available MicroVention Woven EndoBridge device as part of routine clinical care at participating study centers in China. The registry includes both retrospectively identified patients and prospectively enrolled patients. Clinical, procedural, imaging, and safety data will be collected according to the study protocol.
Who may be able to join
- Retrospective Cohort:
- Participants of any age and sex.
- Patients treated for an intracranial aneurysm using a commercially available MicroVention Woven EndoBridge device.
- Patients who completed at least one postoperative imaging follow-up.
- Prospective Cohort:
- Participants of any age and sex.
- Patients treated for an intracranial aneurysm using a commercially available MicroVention Woven EndoBridge device.
- The participant, or legally authorized representative if applicable, understands the study requirements and procedures and provides written informed consent before any study-specific data collection.
Who cannot join
- Retrospective Cohort:
- Patients treated with a Woven EndoBridge device for whom intraoperative or postoperative follow-up imaging data are not available.
- Patients considered by the investigator to be unsuitable for participation in this study.
- Prospective Cohort:
- Participants who are currently participating in, or plan to participate during the follow-up period, another clinical study that may affect the results of this study.
- Patients who are currently unable or expected to be unable to complete follow-up.
- Patients with a life expectancy of less than 1 year due to other diseases or conditions.
- Patients considered by the investigator to be unsuitable for participation in this study.
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, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, 100053
Xin Su, +8618210685023, 1258940078@qq.com
Simin Wang, wsm158524@126.com
About this study
Official title: A Real-World Study of Intrasaccular Flow Disruption Devices for the Treatment of Intracranial Aneurysms
We designed the Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS), an ambidirectional, multicenter, post-market real-world study with a prospective active surveillance component. The study will include patients with IAs treated with commercially available WEB devices under the direction of treating physicians in routine clinical practice. Clinical, procedural, imaging, and safety data will be collected using a standardized electronic data capture system, with safety events adjudicated by an independent clinical events committee and imaging outcomes assessed by an independent core laboratory. The primary objective is to evaluate 12-month adequate aneurysm occlusion and major adverse events after WEB treatment. The study is expected to provide comprehensive post-market evidence on the real-world performance of the WEB device in China, including its safety, effectiveness, clinical appropriateness, and health economic value in routine neurointerventional practice.
Read the detailed description
Intracranial aneurysms are abnormal dilatations of blood vessels in the brain. If an aneurysm ruptures, it can cause subarachnoid hemorrhage, which may lead to serious disability or death. Endovascular treatment has become an important treatment option for intracranial aneurysms. The Woven EndoBridge (WEB) device is an intrasaccular flow disruption device designed to treat selected intracranial aneurysms from within the aneurysm sac.
This study is a post-market, ambispective, multicenter, real-world registry study. It will evaluate the safety and performance of commercially available MicroVention WEB devices when used by treating physicians according to routine clinical practice and the approved instructions for use. The study does not assign participants to a treatment group and does not require a randomized comparison. Treatment decisions are made by the treating physicians based on standard medical care.
The study plans to enroll up to 1,000 patients from multiple study centers in China. Approximately 200 patients will be included retrospectively, and approximately 800 patients will be included prospectively. Eligible participants are patients with intracranial aneurysms treated with a commercially available WEB device. For the prospective cohort, written informed consent will be obtained from the participant or legally authorized representative before study-related data collection, as applicable.
Clinical data will be collected using an electronic data capture system. Imaging data will be de-identified and submitted for independent core laboratory assessment. Follow-up assessments are planned after the procedure and at approximately 30 days, 6 months, and 12 months. Follow-up may include neurological assessment, imaging evaluation, information on aneurysm retreatment, adverse event assessment, serious adverse event assessment, and information on antiplatelet or anticoagulant medication use.
The primary effectiveness outcome is the proportion of aneurysms with adequate occlusion at 12 months, based on the Raymond-Roy Occlusion Classification. Adequate occlusion is defined as Raymond-Roy class I or II. The primary safety outcome is the rate of major adverse events, including unexpected death or major stroke within 30 days after the procedure, and neurological death or major stroke from 31 days to 1 year after the procedure.
Other outcomes include aneurysm occlusion based on the WEB Occlusion Scale, aneurysm recurrence, aneurysm retreatment, rebleeding, parent artery patency, clinical outcome measured by the modified Rankin Scale, device-related serious adverse events, procedure-related serious adverse events, neurological events, successful device implantation and health economic outcomes. The study will mainly use descriptive statistical methods to summarize outcomes and confidence intervals.
- Conditions
- Intracranial Aneurysm
- Being tested
- Intrasaccular Flow Disruption Device
- Keywords
- Woven EndoBridge, WEB Device, Intrasaccular Flow Disruption, Endovascular Treatment, Intracranial Aneurysm, Aneurysm Embolization, Real-World Study, Post-Market Study, Raymond-Roy Occlusion Classification, WEB Occlusion Scale, Active surveillance
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrasaccular Flow Disruption DeviceDevice
Also called Woven EndoBridge, WEB Device, MicroVention WEB Device, Woven EndoBridge Aneurysm Embolization System
The intervention of interest is treatment of intracranial aneurysms using the commercially available MicroVention Woven EndoBridge device. The device is an intrasaccular flow disruption device used during endovascular treatment according to routine clinical practice and the approved instructions for use. Treatment decisions and procedural details are determined by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Patients Treated With the Woven EndoBridge Device | Patients with intracranial aneurysms who are treated with the commercially available MicroVention Woven EndoBridge device as part of routine clinical care. This cohort includes both retrospectively identified patients and prospectively enrolled patients. Clinical, procedural, imaging, safety, effectiveness, clinical appropriateness, and health economic outcomes will be collected according to the study protocol. Receives: Device: Intrasaccular Flow Disruption Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Events
Major adverse events include unexpected death or major stroke within 30 days after the procedure, and neurological death or major stroke from 31 days to 1 year after the procedure. Major stroke is defined as an ischemic or hemorrhagic stroke associated with an increase of more than 4 points in the NIHSS score.
Measured: Up to 1 Year After the Index Procedure
Proportion of Aneurysms With Adequate Occlusion Based on Raymond-Roy Occlusion Classification
Adequate aneurysm occlusion is defined as Raymond-Roy Occlusion Classification class I or II at the 12-month follow-up. Class I indicates complete occlusion, and class II indicates residual neck without contrast filling of the aneurysm sac.
Measured: 12 Months After the Index Procedure
Secondary outcomes (18)
Proportion of Aneurysms With Adequate Occlusion Based on WEB Occlusion Scale
Adequate aneurysm occlusion will be assessed by an independent imaging core laboratory using the Woven EndoBridge Occlusion Scale. The Woven EndoBridge Occlusion Scale is a categorical angiographic scale ranging from Class A to Class D: Class A indicates complete occlusion, Class B indicates complete occlusion with recess filling, Class C indicates neck remnant, and Class D indicates aneurysm remnant. Adequate occlusion is defined as Class A, Class B, or Class C. Class D indicates inadequate occlusion. This is a categorical scale; higher or lower numerical scores are not applicable.
Measured: 12 Months After the Index Procedure
Aneurysm Occlusion Status Based on Raymond-Roy Occlusion Classification and WEB Occlusion Scale
Aneurysm occlusion status will be assessed by an independent imaging core laboratory using the Raymond-Roy Occlusion Classification and the Woven EndoBridge Occlusion Scale. The Raymond-Roy Occlusion Classification is a categorical angiographic classification ranging from Class I to Class III: Class I indicates complete occlusion, Class II indicates residual neck, and Class III indicates residual aneurysm. The Woven EndoBridge Occlusion Scale is a categorical angiographic scale ranging from Class A to Class D: Class A indicates complete occlusion, Class B indicates complete occlusion with recess filling, Class C indicates neck remnant, and Class D indicates aneurysm remnant. These are categorical scales; higher or lower numerical scores are not applicable.
Measured: 12 Months After the Index Procedure
Aneurysm Occlusion Without Rebleeding in Ruptured Aneurysms
In participants with ruptured aneurysms, aneurysm occlusion status will be assessed together with the absence of rebleeding.
Measured: 12 Months After the Index Procedure
Aneurysm Occlusion Without Rebleeding or Retreatment in Aneurysms With Residual Filling
In aneurysms with residual filling, occlusion status will be assessed together with absence of rebleeding in ruptured aneurysms or absence of retreatment.
Measured: 12 Months After the Index Procedure
Stability of Aneurysm Occlusion
Occlusion stability will be assessed by comparing imaging results between the 6-month and 12-month follow-up visits and classified as unchanged, improved, or worsened.
Measured: From 6 Months to 12 Months After the Index Procedure
Aneurysm Recurrence
Aneurysm recurrence is defined as aneurysm growth or recanalization within 1 year after the index procedure.
Measured: Up to 1 Year After the Index Procedure
Aneurysm Retreatment
The proportion of participants who undergo retreatment of the target aneurysm within 1 year will be assessed.
Measured: Up to 1 Year After the Index Procedure
Unplanned Retreatment or Alternative Treatment
The proportion of participants who undergo unplanned retreatment or alternative treatment due to aneurysm recurrence or residual aneurysm will be assessed.
Measured: Up to 1 Year After the Index Procedure
Rebleeding Within 30 Days in Ruptured Aneurysms
In participants with ruptured aneurysms, rebleeding within 30 days after the procedure will be assessed, excluding intraprocedural rupture or bleeding.
Measured: Up to 30 Days After the Index Procedure
Rebleeding Within 1 Year in Ruptured Aneurysms
In participants with ruptured aneurysms, rebleeding within 1 year after the procedure will be assessed, excluding intraprocedural rupture or bleeding.
Measured: Up to 1 Year After the Index Procedure
New Bleeding of the Target Aneurysm in Unruptured Aneurysms
In participants with unruptured aneurysms, new bleeding of the target aneurysm within 1 year will be assessed, excluding intraprocedural rupture or bleeding.
Measured: Up to 1 Year After the Index Procedure
Parent Artery Patency
Parent artery patency will be assessed at 1 year, defined as less than 50% stenosis of the parent artery or absence of clinical symptoms.
Measured: 12 Months After the Index Procedure
Clinical Outcome Measured by Modified Rankin Scale
Clinical outcome will be assessed using the Modified Rankin Scale (mRS). The Modified Rankin Scale is an ordinal scale ranging from 0 to 6, where 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death. Higher scores indicate worse functional outcome.
Measured: 30 Days, 6 Months, and 12 Months After the Index Procedure
Device-Related Serious Adverse Events
Serious adverse events related to the study device will be collected and summarized.
Measured: Up to 1 Year After the Index Procedure
Procedure-Related Serious Adverse Events
Serious adverse events related to the procedure will be collected and summarized.
Measured: Up to 1 Year After the Index Procedure
Device- or Procedure-Related Adverse Events
Periprocedural and postprocedural adverse events related to the device or procedure will be collected and summarized.
Measured: Up to 1 Year After the Index Procedure
Neurological Events
Neurological events will include ischemic stroke, hemorrhagic stroke, neurological death, intracerebral hemorrhage, subarachnoid hemorrhage, arterial thrombosis, parent artery or branch artery perforation or rupture, and transient ischemic attack.
Measured: Up to 1 Year After the Index Procedure
Proportion of Target Aneurysms With Successful Woven EndoBridge Device Implantation
Successful device implantation will be assessed using the procedure record and electronic case report form. Successful Woven EndoBridge device implantation is defined as successful deployment and detachment of the Woven EndoBridge device in the target aneurysm during the index procedure. The outcome will be reported as the proportion of target aneurysms with successful device implantation among target aneurysms in which Woven EndoBridge device implantation was attempted. Reasons for unsuccessful implantation, such as inappropriate device size or model, unsuitable target aneurysm anatomy, unfavorable angle, vascular tortuosity preventing access to the lesion, or other reasons, will be recorded when applicable.
Measured: During the Index Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, ZhuHai Hospital, Third Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, Guangdong Second Provincial General Hospital, Zhujiang Hospital, Nanfang Hospital, Southern Medical University, The First Medical Center of Chinese PLA General Hospital, Beijing Chao Yang Hospital, Beijing Tiantan Hospital, Zhongnan Hospital, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital, Fudan University, RenJi Hospital, Ruijin Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Nanyang Central Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Air Force Medical University, The Second Affiliated Hospital of Air Force Military Medical University, Sichuan Provincial People's Hospital, West China Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, Xiangya Hospital of Central South University, The Second Xiangya Hospital, Central South University, The First Hospital of Jilin University, Second Hospital of Jilin University, Nanjing Gulou Hospital, First Hospital of China Medical University, Qilu Hospital of Shandong University, First Affiliated Hospital of Chongqing Medical University, People's Hospital of Guangxi Zhuang Autonomous Region, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Fujian Medical University, MicroVention, Inc., a Terumo company, Anhui Provincial Hospital, Zhongshan Hospital of Hubei Province, Beijing Haidian Hospital, Peking University Third Hospital, Beijing Anzhen Hospital, Yichang Central People's Hospital, The General Hospital of Eastern Theater Command, The General Hospital of Northern Theater Command, Southwest Hospital, China, Guangxi Hospital of the First Affiliated Hospital, Sun Yat-sen University, Affiliated Hospital of Yunnan University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Tangshan Worker's Hospital, The Affiliated Hospital of Qingdao University
- Responsible party
- Principal investigator, Hongqi Zhang, MD, Xuanwu Hospital, Beijing
- Investigators
- Hongqi Zhang, Study chair, Xuanwu Hospital, BeijingHongqi Zhang, Study director, Xuanwu Hospital, BeijingXin Su, Principal investigator, Xuanwu Hospital, BeijingSimin Wang, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620626
- Sponsor's protocol ID
- xwzhqsxwsmhyf
- Acronym
- WEB-RWS
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study of Intrasaccular Flow Disruption Devices for the Treatment of Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT07620626
- Acronym / sponsor ID
- WEB-RWS / xwzhqsxwsmhyf
- Conditions
- Intracranial Aneurysm
- Keywords
- Woven EndoBridge, WEB Device, Intrasaccular Flow Disruption, Endovascular Treatment, Intracranial Aneurysm, Aneurysm Embolization, Real-World Study, Post-Market Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, ZhuHai Hospital, Third Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, Guangdong Second Provincial General Hospital, Zhujiang Hospital, Nanfang Hospital, Southern Medical University, The First Medical Center of Chinese PLA General Hospital, Beijing Chao Yang Hospital, Beijing Tiantan Hospital, Zhongnan Hospital, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital, Fudan University, RenJi Hospital, Ruijin Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Nanyang Central Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Air Force Medical University, The Second Affiliated Hospital of Air Force Military Medical University, Sichuan Provincial People's Hospital, West China Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, Xiangya Hospital of Central South University, The Second Xiangya Hospital, Central South University, The First Hospital of Jilin University, Second Hospital of Jilin University, Nanjing Gulou Hospital, First Hospital of China Medical University, Qilu Hospital of Shandong University, First Affiliated Hospital of Chongqing Medical University, People's Hospital of Guangxi Zhuang Autonomous Region, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Fujian Medical University, MicroVention, Inc., a Terumo company, Anhui Provincial Hospital, Zhongshan Hospital of Hubei Province, Beijing Haidian Hospital, Peking University Third Hospital, Beijing Anzhen Hospital, Yichang Central People's Hospital, The General Hospital of Eastern Theater Command, The General Hospital of Northern Theater Command, Southwest Hospital, China, Guangxi Hospital of the First Affiliated Hospital, Sun Yat-sen University, Affiliated Hospital of Yunnan University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Tangshan Worker's Hospital, The Affiliated Hospital of Qingdao University
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 Jun 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.
We designed the Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS), an ambidirectional, multicenter, post-market real-world study with a prospective active surveillance component. The study will include patients with IAs treated with commercially available WEB devices under the direction of treating physicians in routine clinical practice. Clinical, procedural, imaging, and safety data will be collected using a standardized electronic data capture system, with safety events adjudicated by an independent clinical events committee and imaging outcomes assessed by an independent core laboratory. The primary objective is to evaluate 12-month adequate aneurysm occlusion and major adverse events after WEB treatment. The study is expected to provide comprehensive post-market evidence on the real-world performance of the WEB device in China, including its safety, effectiveness, clinical appropriateness, and health economic value in routine neurointerventional practice.
Detailed description
Intracranial aneurysms are abnormal dilatations of blood vessels in the brain. If an aneurysm ruptures, it can cause subarachnoid hemorrhage, which may lead to serious disability or death. Endovascular treatment has become an important treatment option for intracranial aneurysms. The Woven EndoBridge (WEB) device is an intrasaccular flow disruption device designed to treat selected intracranial aneurysms from within the aneurysm sac.
This study is a post-market, ambispective, multicenter, real-world registry study. It will evaluate the safety and performance of commercially available MicroVention WEB devices when used by treating physicians according to routine clinical practice and the approved instructions for use. The study does not assign participants to a treatment group and does not require a randomized comparison. Treatment decisions are made by the treating physicians based on standard medical care.
The study plans to enroll up to 1,000 patients from multiple study centers in China. Approximately 200 patients will be included retrospectively, and approximately 800 patients will be included prospectively. Eligible participants are patients with intracranial aneurysms treated with a commercially available WEB device. For the prospective cohort, written informed consent will be obtained from the participant or legally authorized representative before study-related data collection, as applicable.
Clinical data will be collected using an electronic data capture system. Imaging data will be de-identified and submitted for independent core laboratory assessment. Follow-up assessments are planned after the procedure and at approximately 30 days, 6 months, and 12 months. Follow-up may include neurological assessment, imaging evaluation, information on aneurysm retreatment, adverse event assessment, serious adverse event assessment, and information on antiplatelet or anticoagulant medication use.
The primary effectiveness outcome is the proportion of aneurysms with adequate occlusion at 12 months, based on the Raymond-Roy Occlusion Classification. Adequate occlusion is defined as Raymond-Roy class I or II. The primary safety outcome is the rate of major adverse events, including unexpected death or major stroke within 30 days after the procedure, and neurological death or major stroke from 31 days to 1 year after the procedure.
Other outcomes include aneurysm occlusion based on the WEB Occlusion Scale, aneurysm recurrence, aneurysm retreatment, rebleeding, parent artery patency, clinical outcome measured by the modified Rankin Scale, device-related serious adverse events, procedure-related serious adverse events, neurological events, successful device implantation and health economic outcomes. The study will mainly use descriptive statistical methods to summarize outcomes and confidence intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Treated With the Woven EndoBridge Device | – | Device: Intrasaccular Flow Disruption DevicePatients with intracranial aneurysms who are treated with the commercially available MicroVention Woven EndoBridge device as part of routine clinical care. This cohort includes both retrospectively identified patients and prospectively enrolled patients. Clinical, procedural, imaging, safety, effectiveness, clinical appropriateness, and health economic outcomes will be collected according to the study protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes patients with intracranial aneurysms who are treated with the commercially available MicroVention Woven EndoBridge device as part of routine clinical care at participating study centers in China. The registry includes both retrospectively identified patients and prospectively enrolled patients. Clinical, procedural, imaging, and safety data will be collected according to the study protocol.
Key inclusion criteria (8 listed)
- Participants of any age and sex.
- Patients treated for an intracranial aneurysm using a commercially available MicroVention Woven EndoBridge device.
- Patients who completed at least one postoperative imaging follow-up.
- Participants of any age and sex.
- Patients treated for an intracranial aneurysm using a commercially available MicroVention Woven EndoBridge device.
Key exclusion criteria (8 listed)
- Patients treated with a Woven EndoBridge device for whom intraoperative or postoperative follow-up imaging data are not available.
- Patients considered by the investigator to be unsuitable for participation in this study.
- Participants who are currently participating in, or plan to participate during the follow-up period, another clinical study that may affect the results of this study.
- Patients who are currently unable or expected to be unable to complete follow-up.
- Patients with a life expectancy of less than 1 year due to other diseases or conditions.
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 |
|---|---|---|
| Intrasaccular Flow Disruption DeviceAlso: Woven EndoBridge, WEB Device, MicroVention WEB Device, Woven EndoBridge Aneurysm Embolization SystemThe intervention of interest is treatment of intracranial aneurysms using the commercially available MicroVention Woven EndoBridge device. The device is an intrasaccular flow disruption device used during endovascular treatment according to routine clinical practice and the approved instructions for use. Treatment decisions and procedural details are determined by the treating physician. | Device | Patients Treated With the Woven EndoBridge Device |
Primary outcome
Incidence of Major Adverse Events
Time frame: Up to 1 Year After the Index Procedure
Major adverse events include unexpected death or major stroke within 30 days after the procedure, and neurological death or major stroke from 31 days to 1 year after the procedure. Major stroke is defined as an ischemic or hemorrhagic stroke associated with an increase of more than 4 points in the NIHSS score.
Proportion of Aneurysms With Adequate Occlusion Based on Raymond-Roy Occlusion Classification
Time frame: 12 Months After the Index Procedure
Adequate aneurysm occlusion is defined as Raymond-Roy Occlusion Classification class I or II at the 12-month follow-up. Class I indicates complete occlusion, and class II indicates residual neck without contrast filling of the aneurysm sac.
18 secondary outcomes
Proportion of Aneurysms With Adequate Occlusion Based on WEB Occlusion Scale
Time frame: 12 Months After the Index Procedure
Aneurysm Occlusion Status Based on Raymond-Roy Occlusion Classification and WEB Occlusion Scale
Time frame: 12 Months After the Index Procedure
Aneurysm Occlusion Without Rebleeding in Ruptured Aneurysms
Time frame: 12 Months After the Index Procedure
Aneurysm Occlusion Without Rebleeding or Retreatment in Aneurysms With Residual Filling
Time frame: 12 Months After the Index Procedure
Stability of Aneurysm Occlusion
Time frame: From 6 Months to 12 Months After the Index Procedure
Aneurysm Recurrence
Time frame: Up to 1 Year After the Index Procedure
Aneurysm Retreatment
Time frame: Up to 1 Year After the Index Procedure
Unplanned Retreatment or Alternative Treatment
Time frame: Up to 1 Year After the Index Procedure
Rebleeding Within 30 Days in Ruptured Aneurysms
Time frame: Up to 30 Days After the Index Procedure
Rebleeding Within 1 Year in Ruptured Aneurysms
Time frame: Up to 1 Year After the Index Procedure
New Bleeding of the Target Aneurysm in Unruptured Aneurysms
Time frame: Up to 1 Year After the Index Procedure
Parent Artery Patency
Time frame: 12 Months After the Index Procedure
Clinical Outcome Measured by Modified Rankin Scale
Time frame: 30 Days, 6 Months, and 12 Months After the Index Procedure
Device-Related Serious Adverse Events
Time frame: Up to 1 Year After the Index Procedure
Procedure-Related Serious Adverse Events
Time frame: Up to 1 Year After the Index Procedure
Device- or Procedure-Related Adverse Events
Time frame: Up to 1 Year After the Index Procedure
Neurological Events
Time frame: Up to 1 Year After the Index Procedure
Proportion of Target Aneurysms With Successful Woven EndoBridge Device Implantation
Time frame: During the Index 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 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 study chair
Xuanwu Hospital, Beijing
Hongqi Zhang study director
Xuanwu Hospital, Beijing
Xin Su 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Jun 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 (time frame: Up to 1 Year After the Index 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?
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 11 Jun 2026.