The purpose of this study is to assess the safety and effectiveness of the Separator 3D as a component of the Penumbra System in the revascularization of large vessel occlusion (>2.5mm in diameter) in acute ischemic stroke.
This is a prospective, randomized, single blind, concurrent controlled, multi-center study to assess up to 230 evaluable patients at up to 50 centers presenting with acute ischemic stroke from large vessels occlusions (>2.5mm in diameter) accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. They must be refractory to or not eligible for thrombolytic therapy and assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D. Each treated patient will be followed and assessed for 3 months after the procedure. Each center will have two roll-in patients before actual enrollment. These patients will not be part of the trial but will be followed for 90 days post-procedure for safety.