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

Hohenstatt, S.; Costalat, V.; Dargazanli, C.; Killer-Oberpfalzer, M.; Schreiber, B.; Rautio, R.; Sinisalo, M.; Lamin, S.; Chew, HS.; Spelle, L.; Tomasello, A.; Patankar, T.; Piano, M.; Fiehler, J.; Mohlenbruch, MA.

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

All Authors

Hohenstatt, S.

Costalat, V.

Dargazanli, C.

Killer-Oberpfalzer, M.

Schreiber, B.

Rautio, R.

Sinisalo, M.

Lamin, S.

Chew, HS.

Spelle, L.

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LTHT Author

Patankar, Tufail

LTHT Department

Radiology
Interventional Neuroradiology

Publication Date

2025

Item Type

Journal Article

Abstract

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.