WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
NCT ID: NCT01778322
Last Updated: 2023-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
51 participants
OBSERVATIONAL
2011-12-31
2019-12-31
Brief Summary
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Detailed Description
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* Aneurysm morphology
* Aneurysm size
* For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH)
* Size of the embolization device(s) used in the procedure
* Intra-procedural assessment of aneurysm occlusion and flow stasis
* Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and other scores as appropriate)
* Aneurysm occlusion durability
* Recanalization rate
* Device-related changes in Modified Rankin Scale from baseline
* Complications/adverse events
* Rebleed/new bleed
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Index Embolization Cohort
WEB Aneurysm Embolization System
Intracranial aneurysm embolization
Treatment of intracranial aneurysms
Interventions
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Intracranial aneurysm embolization
Treatment of intracranial aneurysms
Eligibility Criteria
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Inclusion Criteria
* Must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures
Exclusion Criteria
* Must not have lesion with characteristics unsuitable for endovascular treatment
* Must not have neurologic or psychiatric conditions, which preclude ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
* Must not be concurrently involved in another investigational or post-market study
* Must not have received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial
18 Years
75 Years
ALL
No
Sponsors
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Microvention-Terumo, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Laurent Pierot, MD
Role: PRINCIPAL_INVESTIGATOR
CHU REIMS
Locations
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Rigshospitalet
Copenhagen, , Denmark
Hôpital Beaujon
Clichy, , France
CHU Gui de Chauliac
Montpellier, , France
CHU Reims Maison Blanche
Reims, , France
CHU Purpan
Toulouse, , France
CHU Bretonneau
Tours, , France
Uniklinik Koeln
Cologne, , Germany
Helios Klinikum
Erfurt, , Germany
Klinikum der Johann Wolfgang Goethe Universität
Frankfurt, , Germany
Klinikum Vest GmbH
Recklinghausen, , Germany
Klinikum Stuttgart- Katharinenhospital
Stuttgart, , Germany
National Institute of Neurosciences
Budapest, , Hungary
Countries
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References
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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.
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.
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.
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.
Related Links
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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).
Safety and efficacy of aneurysm treatment with WEB: results of the WEBCAST study.
Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of Three Prospective, Multicenter Series: 2-Year Follow-up
Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up
Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up
Safety and Efficacy of Aneurysm Treatment with the WEB: Results of the WEBCAST 2 Study
Other Identifiers
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CP 11-001
Identifier Type: -
Identifier Source: org_study_id
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