TY - JOUR T1 - Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results JF - Journal of NeuroInterventional Surgery JO - J NeuroIntervent Surg SP - 62 LP - 66 DO - 10.1136/neurintsurg-2019-015091 VL - 12 IS - 1 AU - Ricardo A Hanel AU - David F Kallmes AU - Demetrius Klee Lopes AU - Peter Kim Nelson AU - Adnan Siddiqui AU - Pascal Jabbour AU - Vitor M Pereira AU - Istvan Szikora István AU - Osama O Zaidat AU - Chetan Bettegowda AU - Geoffrey P Colby AU - Maxim Mokin AU - Clemens Schirmer AU - Frank R Hellinger AU - Curtis Given II AU - Timo Krings AU - Philipp Taussky AU - Gabor Toth AU - Justin F Fraser AU - Michael Chen AU - Ryan Priest AU - Peter Kan AU - David Fiorella AU - Don Frei AU - Beverly Aagaard-Kienitz AU - Orlando Diaz AU - Adel M Malek AU - C Michael Cawley AU - Ajit S Puri Y1 - 2020/01/01 UR - http://jnis.bmj.com/content/12/1/62.abstract N2 - Background Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications.Objective To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.Methods PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death.Results A total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study’s primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140).Conclusions Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications.Trial registration NCT02186561. ER -