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Advanced Neurology                                     Woven Endobridge embolization: Indications and innovation




            Table 1. (Continued)
             Study             Title                    Status        Population                     References
            NCT03379714 (Belgium)  Mid-term Data Collection of   Withdrawn  -                            -
                               the Treatment of Intracranial
                               Aneurysms with the WEB
                               aneurysm Embolization System
            NCT04839705        Post Approval Study – Evaluate   Not yet recruiting  -                   [72]
            (United States)    the Long-term Safety and
                               Effectiveness of the WEB Device
                               (WEB PAS)
            NCT03207087 (China)   The WEB-IT China Clinical study  Unknown status  -                    [73]
            Abbreviations: ACA: Anterior cerebral artery; Acom: Anterior communicating artery; BA: Basilar artery; IA: Intracranial aneurysm; ICA: Internal
            carotid artery; MCA: Middle cerebral artery; Pcom: Posterior communicating artery.

            Table 2. Summary of completed clinical trials result
             Study         Title             Study type  Conditions   Interventional   Results       References
                                                                      treatment
            NCT04621552    Virtual Simulation for   Observational  Aneurysm;   Device: WEB   Virtual simulation reduced   [64]
            (France)       Woven EndoBridge             intracranial   embolization  time of intervention;
                           Device Sizing                aneurysm                   decreased radiation dose,
                                                                                   number of undeployed
                                                                                   devices, and need for
                                                                                   corrective interventions.
            NCT01975233    WEB French Observatory  Observational  Brain aneurysm  Device: WEB   High rate of complete   [65]
            (France)       of the WEB Aneurysm                       aneurysms     occlusion (51.7%) and
                           Embolization System                       embolization   adequate occlusion (79.3%)
                                                                     systems       at 1 year.
            NCT01778322    WEB Clinical Assessment  Observational  Intracranial   Procedure:   56.1% complete occlusion,   [66]
            (Denmark France,   of Intrasaccular Aneurysm   aneurysm   Intracranial   29.3% neck remnant, and
            Germany, Hungary)  Therapy (WEBCAST)                     aneurysm      14.6% aneurysm remnant
                                                                     embolization  at 6 months.
            NCT02687607    Clinical Assessment of   Observational  Brain aneurysm  WEB aneurysm   41.3% complete occlusion   [67]
            (France)       WEB Device in Ruptured                    embolization   and 87% adequate
                           Aneurysms (CLARYS)                        system        occlusion at 1 year,
                                                                                   effective protection against
                                                                                   rebleeding.
            NCT02191618    The WEB-IT Clinical   Single group   Wide-neck   Device: WEB  53.8% complete aneurysm   [69]
            (Canada, Denmark,  Study         interventional  bifurcation           occlusion and 84.6%
            Germany,                                    intracranial               adequate occlusion.
            Hungary, Turkey,                            aneurysms;
            United States)                              intracranial
                                                        aneurysms
            Abbreviations: CLARYS: Clinical Assessment of WEB Device in Ruptured Aneurysms; WEBCAST: WEB Clinical Assessment of Intrasaccular
            Aneurysm Therapy; WEB: Woven Endobridge device; WEB-IT: Woven Endobridge Intrasaccular Therapy.

            in 54.0% of the aneurysms, neck remnant in 26.0%, and   system’s safety and effectiveness for treatment of wide-
                                                                                                  [23]
            an aneurysm remnant in 20.0%. Adequate occlusion was   neck bifurcation aneurysms (Table 2) . Mortality
            reported in 80.0%. More recently, data have been published   remained 0.0% throughout the entire 12-month study
                                                                    [24]
            with  a  cumulative  trial  population  of  WEBCAST  and   period . In the case-controlled and multicenter study
            WEBCAST-2 at 3  years  and 5-year analysis  that   (NCT04621552), investigators compared a virtual
                                                    [22]
                                [21]
            shows long-term aneurysm stability and occlusion rate in   simulation with conventional sizing  to determine  the
            aneurysms treated with the WEB devices.            appropriate WEB device size for an aneurysm. The results
                                                               demonstrated fulfillment of the primary outcome measure
              The  WEB  Intrasaccular  Therapy  (WEB-IT)  study   by shortening the intervention time, lowering the radiation
            (NCT02191618) also aimed to validate further the WEB   dose, and lowering the number of WEB devices not


            Volume 2 Issue 3 (2023)                         4                          https://doi.org/10.36922/an.293
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