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

Hohenstatt, Sophia; Costalat, Vincent; Dargazanli, Cyril; Killer-Oberpfalzer, Monika; Schreiber, Barbara; Rautio, Riitta; Sinisalo, Matias; Lamin, Saleh; Chew, Han Seng; Spelle, Laurent; Tomasello, Alejandro; Patankar, Tufail; Piano, Mariangela; Fiehler, Jens; Möhlenbruch, Markus A.
New Artisse intrasaccular device for intracranial aneurysm treatment: short term clinical and angiographic result from the prospective registry INSPIRE-A

Hohenstatt, Sophia
Costalat, Vincent
Dargazanli, Cyril
Killer-Oberpfalzer, Monika
Schreiber, Barbara
Rautio, Riitta
Sinisalo, Matias
Lamin, Saleh
Chew, Han Seng
Spelle, Laurent
Tomasello, Alejandro
Patankar, Tufail
Piano, Mariangela
Fiehler, Jens
Möhlenbruch, Markus A.
Katso/Avaa
Lataukset: 

BMJ PUBLISHING GROUP
doi:10.1136/jnis-2024-022576
URI
https://doi.org/10.1136/jnis-2024-022576
Näytä kaikki kuvailutiedot
Julkaisun pysyvä osoite on:
https://urn.fi/URN:NBN:fi-fe2025082791473
Tiivistelmä

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.

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