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An observational non-randomized, multi-center, prospective assessment of the clinical utility of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms deemed appropriate for endovascular treatment. The population being treated in this Registry is a subset of the CE marked indication.
All eligible subjects presenting to the participating Registry Center will be considered for entry into the Registry. Up to 70 evaluable subjects meeting the Registry entry criteria will be enrolled.
An intermediary analysis will be performed when the first forty (40) subjects reaching the planned one month follow-up.
subjects will be followed per Institution's standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WEB Aneurysm Embolization System | Subjects aged ℠18 years, but †80 years requiring treatment for single ruptured intracranial aneurysms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WEB Aneurysm Embolization System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Re-Bleed rate after treatment | Re-bleeding rate after treatment of the target aneurysm with WEB, during the period extending from post-procedure up to 1 month. Definitions:
Or, as per-center standard care, non-enhanced CT or MRI might be performed systematically during hospital course. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Aneurysm occlusion | Angiographic (conventional or CT-Angio or MR-Angio) occlusion at 12month based on WEB occlusion scale (WOS) | 12 months |
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Inclusion Criteria:
The decision to use a WEB device to treat the patient has been made before and independently of the decision to include the patient in this Registry
Subject must be â„ 18 years and < 80 years of age
Subject must have a single intracranial aneurysm ruptured within 30 days requiring treatment according to a multidisciplinary decision Definition: For the purposes of this study a ruptured IA patient is defined as a patient with computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP) evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 30 days.
If the subject has one or more additional aneurysm, the additional aneurysm must not require treatment in emergency or within 30 days of the index procedure
Subject with Hunt & Hess Score of I, II or III
Conventional or Flat-panel CT is performed within 6hrs prior to femoral puncture (or just before WEB placement if any clinical worsening is noted before the treatment) to assess absence of re-bleeding prior the treatment
Aneurysm to be treated must have the following characteristics i. Morphology - saccular ii. Location
Subject must be considered by the physician to be available for subsequent visits
Subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
Subject, or its legal representative, must have received information regarding the data collection and data protection within this clinical evaluation, or must have signed the informed consent when locally mandatory.
Exclusion Criteria:
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The decision to use a WEB device to treat the patient has been made before and independently of the decision to include the patient in this Registry
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Spelle, MD, PhD | CHU Bicetre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neuroradiologie | Le Kremlin-BicĂȘtre | 94270 | France |
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| Label | URL |
|---|---|
| CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter study | View source |
| CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study | View source |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D017542 | Aneurysm, Ruptured |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |