Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms
The following parameters will be evaluated as part of this study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Index Embolization Cohort | WEB Aneurysm Embolization System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracranial aneurysm embolization | Procedure | Treatment of intracranial aneurysms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Durability of occlusion | Evaluated by the Corelab | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence/recanalization rate | Evaluated by the Corelab, based on Raymond Roy occlusion scale | 6 months |
| Modified Raymond Scale | Evaluation of patient's functional level of activity by the physician |
| Measure | Description | Time Frame |
|---|---|---|
| Fluoroscopy time | Duration of fluoroscopy time will be recorded during the procedure | procedure |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Subjects with:
- Diameter and width of the aneurysm is appropriate size for treatment with the WEB Aneurysm Embolization System per device Instructions for Use
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laurent Pierot, MD | CHU de Reims | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark | |||
| Hôpital Beaujon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35803731 | Derived | Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Klisch J, Herbreteau D, Costalat V, Fiehler J, Januel AC, Liebig T, Stockx L, Weber W, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up. J Neurointerv Surg. 2023 Jun;15(6):552-557. doi: 10.1136/neurintsurg-2021-018414. Epub 2022 Jul 8. | |
| 32532858 |
| Label | URL |
|---|---|
| Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory). | View source |
Not provided
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| Percentage occlusion of target aneurysm | Evaluated by the Corelab | 6 months |
| Clichy |
| 92118 |
| France |
| CHU Gui de Chauliac | Montpellier | 34295 | France |
| CHU Reims Maison Blanche | Reims | 51092 | France |
| CHU Purpan | Toulouse | 31059 | France |
| CHU Bretonneau | Tours | 37000 | France |
| Uniklinik Koeln | Cologne | 50937 | Germany |
| Helios Klinikum | Erfurt | 99089 | Germany |
| Klinikum der Johann Wolfgang Goethe Universität | Frankfurt | 60528 | Germany |
| Klinikum Vest GmbH | Recklinghausen | 45657 | Germany |
| Klinikum Stuttgart- Katharinenhospital | Stuttgart | 70174 | Germany |
| National Institute of Neurosciences | Budapest | H-1145 | Hungary |
| Derived |
| Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Herbreteau D, Fiehler J, Costalat V, Klisch J, Januel AC, Weber W, Liebig T, Stockx L, Berkefeld J, Moret J, Molyneux A, Byrne J. Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up. J Neurointerv Surg. 2021 Apr;13(4):363-368. doi: 10.1136/neurintsurg-2020-016151. Epub 2020 Jun 12. |
| 28965106 | Derived | Pierot L, Moret J, Barreau X, Szikora I, Herbreteau D, Turjman F, Holtmannspotter M, Januel AC, Costalat V, Fiehler J, Klisch J, Gauvrit JY, Weber W, Desal H, Velasco S, Liebig T, Stockx L, Berkefeld J, Molyneux A, Byrne J, Spelle L. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series. J Neurointerv Surg. 2018 Jun;10(6):553-559. doi: 10.1136/neurintsurg-2017-013448. Epub 2017 Sep 30. |
| 26552042 | Derived | Pierot L, Spelle L, Molyneux A, Byrne J; WEBCAST and French Observatory Investigators. Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory). Neurosurgery. 2016 Jan;78(1):133-41. doi: 10.1227/NEU.0000000000001106. |
| Safety and efficacy of aneurysm treatment with WEB: results of the WEBCAST study. | View source |
| Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of Three Prospective, Multicenter Series: 2-Year Follow-up | View source |
| Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up | View source |
| Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up | View source |
| Safety and Efficacy of Aneurysm Treatment with the WEB: Results of the WEBCAST 2 Study | View source |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |