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New Artisse intrasaccular device for intracranial aneurysm treatment: short term clinical and angiographic result from the prospective registry INSPIRE-A

Background Intrasaccular devices have broadened treatment options for wide necked aneurysms. This study presents the preliminary experience with the Artisse 2.0 device. - Methods Innovative NeurovaScular Product SurveIllance REgistry (INSPIRE) is a non-randomized, multicenter, real world clinical st...

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Main Authors: Hohenstatt, Sophia (Author) , Costalat, Vincent (Author) , Dargazanli, Cyril (Author) , Killer-Oberpfalzer, Monika (Author) , Schreiber, Barbara (Author) , Rautio, Riitta (Author) , Sinisalo, Matias (Author) , Lamin, Saleh (Author) , Chew, Han Seng (Author) , Spelle, Laurent (Author) , Tomasello, Alejandro (Author) , Patankar, Tufail (Author) , Piano, Mariangela (Author) , Fiehler, Jens (Author) , Möhlenbruch, Markus Alfred (Author)
Format: Article (Journal)
Language:English
Published: [January 29, 2025]
In: Journal of neuroInterventional surgery
Year: 2025, Pages: 1-10
ISSN:1759-8486
DOI:10.1136/jnis-2024-022576
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1136/jnis-2024-022576
Verlag, kostenfrei, Volltext: https://jnis.bmj.com/content/early/2025/01/28/jnis-2024-022576
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Author Notes:Sophia Hohenstatt, Vincent Costalat, Cyril Dargazanli, Monika Killer-Oberpfalzer, Barbara Schreiber, Riitta Rautio, Matias Sinisalo, Saleh Lamin, Han Seng Chew, Laurent Spelle, Alejandro Tomasello, Tufail Patankar, Mariangela Piano, Jens Fiehler, Markus A Möhlenbruch
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Summary:Background Intrasaccular devices have broadened treatment options for wide necked aneurysms. This study presents the preliminary experience with the Artisse 2.0 device. - Methods Innovative NeurovaScular Product SurveIllance REgistry (INSPIRE) is a non-randomized, multicenter, real world clinical study with treatment arms for aneurysms (INSPIRE-A) and acute ischemic stroke (INSPIRE-S). This interim analysis included 87 patients enrolled from November 2022 to April 2024 in the INSPIRE-A Artisse cohort across 16 Europoean centers. Procedures followed standard clinical care, with 6 months of follow-up. Safety and efficacy endpoints included major stroke, neurological death, serious adverse events (SAEs), aneurysm occlusion, and retreatment rates. An independent core laboratory assessed imaging, and all SAEs were reviewed by a clinical events committee. The Artisse steering committee provided independent oversight of the data. - Results The Artisse device achieved an overall successful implantation rate of 96.6% (84/87), with satisfactory placement rates of 98.7% (74/75) for unruptured and 88.9% (8/9) for ruptured aneurysms. Following the procedure, 46.2% of unruptured aneurysm patients were receiving antiplatelet therapy (APT), predominantly aspirin monotherapy, while no ruptured aneurysm patients received APT. Device related SAE rate was 1.3% (1/87), and the overall stroke rate was 2.3% (2/87), including both ruptured and unruptured aneurysms. At 6 months, 80.0% (28/35) of patients with unruptured aneurysms showed complete obliteration, with no recurrences or retreatments. - Conclusions Preliminary experience with the Artisse 2.0 device demonstrated high technical success, favorable safety, and efficacy in aneurysm obliteration at 6 months. Larger studies with longer follow-up periods are needed to confirm these findings.
Item Description:Gesehen am 22.10.2025
Physical Description:Online Resource
ISSN:1759-8486
DOI:10.1136/jnis-2024-022576

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