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.
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 Type
OBSERVATIONAL
Enrollment
1,000
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.
Xuanwu Hospital
Beijing, China
RECRUITINGIncidence 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.
Time frame: 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.
Time frame: 12 Months After the Index Procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the Index Procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.