A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke

Service: Trial Number:
091-12
Principal Investigator: Conducted at:
Long Beach Memorial
Currently enrolling additional patients:
Yes

In the United States approximately 800,000 patients experience a new or recurrent stroke each year. Of these, approximately 87% are diagnosed as ischemic (vessel occlusions), while the remaining 13% are attributable to hemorrhagic events (bleeding in the brain). Current therapies for acute stroke are limited to the intravenous administration of a blood thinning medicine called (rtPA) or removing the clot with catheters, both of which have limitations as mono therapies. The Penumbra System® is a new generation of clot removing devices specifically designed to remove thrombus through aspiration (suction). The System has received 510(k) clearance from the US FDA for an acute ischemic stroke recanalization indication. The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System. The separators function to break up the clot while the Penumbra sucks it out. 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 (>3mm in diameter) in acute ischemic stroke. This is a prospective, randomized, concurrent controlled, multi-center study to assess up to 164 evaluable patients at up to 50 centers presenting with acute ischemic stroke from large vessels occlusions (>3mm 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.

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