101. Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results
- Author
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Hanel, Ricardo A, Kallmes, David F, Lopes, Demetrius Klee, Nelson, Peter Kim, Siddiqui, Adnan, Jabbour, Pascal, Pereira, Vitor M, Szikora István, Istvan, Zaidat, Osama O, Bettegowda, Chetan, Colby, Geoffrey P, Mokin, Maxim, Schirmer, Clemens, Hellinger, Frank R, Given Ii, Curtis, Krings, Timo, Taussky, Philipp, Toth, Gabor, Fraser, Justin F, Chen, Michael, Priest, Ryan, Kan, Peter, Fiorella, David, Frei, Don, Aagaard-Kienitz, Beverly, Diaz, Orlando, Malek, Adel M, Cawley, C Michael, and Puri, Ajit S
- Subjects
Hematology ,Neurosciences ,Clinical Research ,Clinical Trials and Supportive Activities ,Stroke ,Cardiovascular ,Adult ,Aged ,Blood Vessel Prosthesis ,Embolization ,Therapeutic ,Female ,Follow-Up Studies ,Humans ,Intracranial Aneurysm ,Male ,Middle Aged ,Prospective Studies ,Retreatment ,Self Expandable Metallic Stents ,Treatment Outcome ,aneurysm ,flow diverter ,artery ,brain ,intervention - Abstract
BackgroundPreliminary 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.ObjectiveTo evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms.MethodsPREMIER 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.ResultsA 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
- Published
- 2020