Clinical trial NCT01778322: WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
Official title: WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-29
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with:

- Diameter and width of the aneurysm is appropriate size for treatment with the WEB Aneurysm Embolization System per device Instructions for Use

Brief summary: The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

Detailed description: The following parameters will be evaluated as part of this study:

* 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

Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age
* Must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures

Exclusion Criteria:

* Must not have clinical or angiographic evidence of vasospasm
* 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

Primary outcomes:
measure: Durability of occlusion
timeFrame: 6 months
Secondary outcomes:
measure: Recurrence/recanalization rate
timeFrame: 6 months
measure: Modified Raymond Scale
timeFrame: 6 months
measure: Percentage occlusion of target aneurysm
timeFrame: 6 months
Other outcomes:
measure: Fluoroscopy time
timeFrame: procedure
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Clichy
country: France
facility: Hôpital Beaujon
city: Montpellier
country: France
facility: CHU Gui de Chauliac
city: Reims
country: France
facility: CHU Reims Maison Blanche
city: Toulouse
country: France
facility: CHU Purpan
city: Tours
country: France
facility: CHU Bretonneau
city: Cologne
country: Germany
facility: Uniklinik Koeln
city: Erfurt
country: Germany
facility: Helios Klinikum
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universität
city: Recklinghausen
country: Germany
facility: Klinikum Vest GmbH
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart- Katharinenhospital
city: Budapest
country: Hungary
facility: National Institute of Neurosciences
Study officials:
affiliation: CHU REIMS
name: Laurent Pierot, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.