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Penumbra System Added to IMS III Stroke Trial Protocol

October 21, 2009—Penumbra, Inc. (Alameda, CA) announced that the Penumbra system has been added as a therapeutic option in the combined intravenous and intraarterial (IV/IA) therapy arm of the IMS III (International Management of Stroke III) trial, a prospective, randomized, controlled, international study of acute stroke intervention sponsored by the University of Cincinnati and the National Institute of Neurological Disorders and Stroke.

Penumbra System Added to IMS III Stroke Trial Protocol

October 21, 2009—Penumbra, Inc. (Alameda, CA) announced that the Penumbra system has been added as a therapeutic option in the combined intravenous and intra-arterial (IV/IA) therapy arm of the IMS III (International Management of Stroke III) trial, a prospective, randomized, controlled, international study of acute stroke intervention sponsored by the University of Cincinnati and the National Institute of Neurological Disorders and Stroke.

IMS III Stroke Trial to Include Covidien's Solitaire FR Device

January 30, 2012—Covidien (Mansfield, MA) announced that the Solitaire FR revascularization device has been approved for investigational use in the Interventional Management of Stroke trial (IMS III).The company noted that the IMS III trial will compare a combined intravenous and intra-arterial treatment to the standard FDA-approved approach of administering intravenous rt-PA (recombinant tissue plasminogen activator) alone for restoring blood flow to the brain.

IMS III Trial Enrollment Halted Due to Futility

May 2, 2012—The National Institute of Neurological Disorders and Stroke (NINDS) announced that the Interventional Management of Stroke III (IMS III) trial has stopped enrollment. The randomized, multicenter IMS III trial was designed to evaluate whether the combined use of intravenous tissue plasminogen activator and an intra-arterial therapy cleared by the US Food and Drug and Administration was better than intravenous tissue plasminogen activator alone for the treatment of acute ischemic stroke.  According to the NINDS, the trial's independent Data and Safety Monitoring Board reviewed a preplanned interim analysis on April 18, 2012, and the data showed that the study had a very low likelihood of demonstrating the prespecified, clinically significant difference in benefit between the treatment arms of the study. The board's decision was based on the primary outcome in the study, the modified Rankin score at 3 months, meeting the threshold for futility. This analysis included data from 587 participants who were enrolled at more than 50 sites worldwide.

Analysis Supports Endovascular Therapy After tPA Within 3 Hours of Symptom Onset of Severe Ischemic Stroke

December 15, 2015—Online in Stroke, Joseph P. Broderick, MD, et al, published findings from an assessment of the effect of endovascular treatment in acute ischemic stroke patients with severe neurologic deficit after a prespecified analysis plan.

One-Year Quality-of-Life Outcomes Reported From IMS III Trial

May 13, 2015—In Stroke, Yuko Y. Palesch, PhD, et al published 12-month clinical and quality-of-life (QoL) outcomes from the Interventional Management of Stroke III (IMS III) trial, which concluded that endovascular therapy improves functional outcome and health-related QoL at 12 months after severe ischemic stroke (2015;46:1321–1327).

IMS 3 Stroke Study Shows Lack of Benefit for tPA Plus Endovascular Therapy Versus tPA Alone

February 7, 2013—The American Stroke Association (ASA) announced that results from the Interventional Stroke Management III trial (IMS 3) showed that adding endovascular therapy to clot-busting therapy for stroke did not significantly improve stroke recovery at 3 months.

SAMMPRIS Supports Aggressive Medical Management Over Stenting to Treat Intracranial Artery Stenosis

September 7, 2011—Findings from the SAMMPRIS (Stenting vs Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) trial were published by Marc I. Chimowitz, MBChB, et al online ahead of print in The New England Journal of Medicine. The background of the study is that atherosclerotic intracranial arterial stenosis is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent stroke but that PTAS has not been compared with medical management in a randomized trial.