Forsyth Medical Center

Penumbra Separator 3D

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Study Name/Number: Penumbra Separator 3D

Title: 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

Investigator:  Donald Heck, MD

Purpose: This is a prospective, randomized, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (>3mm in diameter) occlusion in the cerebral circulation will be 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 randomization. The hypothesis to be tested is that the safety and effectiveness of the Penumbra System with the Separator 3D for the revascularization of large vessel occlusion is not inferior to the Penumbra System alone.

Eligibility: From 18-85 years of age. Present with symptoms of an acute ischemic stroke for revascularization within 8 hours from sympton onset, evidence of a large vessel occlusion in the cerebral circulation, NIHSS score great than or equal to 8, signed informed consent.

Contact Information:
Debra Norwood

Link to the current record »