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The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.
All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.
Subjects will be followed per Institution's standard of care.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WEB Aneurysm Embolization System | Device | Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms. |
| Measure | Description | Time Frame |
|---|---|---|
| Aneurysm occlusion | Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms.
| 12 months |
| Incidence of major stroke or neurological deaths | The proportion of subjects with death of any nonaccidental cause or any major stroke 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 | 12months |
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Inclusion Criteria:
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 study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Bicêtre | Le Kremlin-Bicêtre | 94270 | France | |||
| Hôpital Purpan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37914392 | Derived | Spelle L, Costalat V, Caroff J, Wodarg F, Fischer S, Herbreteau D, Mohlenbruch MA, Januel AC, Papagiannaki C, Klisch J, Numminen J, Rautio R, Berlis A, Mihalea C, Chalumeau V, Downer J, Cortese J, Ikka L, Gallas S, Bester M, Liebig T, Velasco S, Grimaldi L, Byrne J, Szikora I, Pierot L, Cognard C. CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms. J Neurointerv Surg. 2024 Nov 22;16(12):1299-1306. doi: 10.1136/jnis-2023-020866. |
| Label | URL |
|---|---|
| CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms | View source |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Toulouse |
| 31059 |
| France |
| Universitätsklinikum Knappschaftskrankenhaus | Bochum | 44892 | Germany |
| National Institute of Clinical Neurosciences | Budapest | 1145 | Hungary |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |