Safety and Effectiveness of the LVIS and LVIS JR Devices for the Treatment of Intracranial Aneurysms

OBJECTIVES	To evaluate the morbidity, mortality, and efficacy of LVIS/LVIS Jr (MicroVention, Inc, AlisoViejo, CA, USA) stents in an intention-to-treat population with ruptured or unruptured intracranial aneurysms.
STUDY	Prospective, observational, and multicenter study that included 17 French centers, conducted between February 2018 and December 2019.
POPULATION	Patients with unruptured, ruptured and recanalized intracranial aneurysms treated with the LVIS stents.
ENDPOINTS	The primary safety endpoint was the cumulative morbidity and mortality rate (CMMR) assessed at 12 months follow-up, defined by the incidence of adverse events (AEs) with sequelae related to the treatment and/or device observed during the procedure up to 1 year after treatment. Secondary endpoints included mRS at 3-6 months and 12-18 months follow-up with favorable and unfavorable outcomes defined by mRS scores of 0−2 and >2, respectively, aneurysmal occlusion by the Raymond-Roy occlusion scale, parent artery, stent patency, and in-stent stenosis. Lastly, another secondary endpoint included the aneurysm retreatment rate at 1-year post-procedure.

Safety and Effectiveness of the LVIS and LVIS JR Devices for the Treatment of Intracranial Aneurysms - LEPI