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This trial is a prospective, multicenter, single-arm confirmatory clinical trial. The study is to confirm the safety and effectiveness of the WEB Aneurysm Embolization System demonstrated in the US WEB-IT Study for the treatment of intracranial wide-neck bifurcation aneurysms. The study's primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by an independent third party core lab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WEB Aneurysm Embolization Device | Experimental | The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant. Subjects will be screened for study eligibility after giving informed consent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WEB Aneurysm Embolization | Device | Subjects will be screened for study eligibility after giving informed consent. The WEB embolization procedure will be performed in the catheterization room using standard angiographic techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis | Proportion of complete (angiographic) aneurysm occlusion as assessed by Core Lab without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment. | 12 month |
| Primary Safety Endpoint: Proportion of death and major stroke | Proportion of death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment. | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital Affiliated to The Second Military Medical University ( Shanghai Changhai Hospital) | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41559830 | Derived | He C, Xu J, Gao X, Li G, Liang G, Jun Y, Zhao Z, Fang B, Xie X, Liu A, Zhang J, Zhang H, Liu J. Woven EndoBridge intrasaccular therapy for the treatment of unruptured wide-necked bifurcation aneurysms: a prospective study in a Chinese population. Chin Neurosurg J. 2026 Jan 20;12(1):2. doi: 10.1186/s41016-025-00418-2. |
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Single group assignment
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Open label
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| West China | Chengdu | Sichuan | China |
| Tiantan Hospital | Beijing | China |
| Xuanwu Hospital, Capital Medical University | Beijing | China |
| The Second affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
| Huashan Hospital | Shanghai | China |
| The General Hospital of Shenyang Military | Shenyang | China |
| Tangdu Hospital, the Fourth Military Medical University | Xi'an | China |