Trial ID or NCT#

NCT01584609

Status

RECRUITING

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.

Up to 164 evaluable patients at up to 50 centers presenting with acute ischemic stroke in vessels accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. 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.

Official 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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Huy M. Do, MD
Interventional neuroradiologist, Radiologist
Professor of Radiology (General Radiology) and, by courtesy, of Neurosurgery at the Stanford University Medical Center

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CONTACT

Stephanie Kemp
(650) 723-4481