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NIH STROKENET: ACUTE INTERVENTIONAL STROKE TRIALS

 MINIMALLY INVASIVE SURGERY PLUS rt-PA FOR ICH EVACUATION

Trial Summary: MISTIE_III

Does faster clot removal give better patient outcomes in ICH? The MISTIE III intervention seeks to remove blood from the brain through minimally invasive surgery and intermittent dosing of a clot-busting drug, a recombinant tissue plasminogen activator (rt-PA) called alteplase, sold under the tradenames of Cathflo Activase by Genentech in the US and as Actilyse by Boehringer Ingelheim in Europe and Asia. The study premise is that by removing the blood clot faster, injury to the brain will be reduced and the patient’s long-term prognosis will improve.

Trial Design Summary:

Primary Objectives: Efficacy: Demonstrate that minimally invasive surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) for three days improves functional outcome by a 12% increase in the modified Rankin Scale (mRS) score 0-3 compared to medically treated subjects assessed at 180 days. Safety: Demonstrate that early use of MIS+rt-PA for three days is safe for the treatment of ICH relative to rates of mortality, rebleeding, and infection in the medically treated subject at 30 days. Secondary Objective: Demonstrate that the end of treatment volume and percent of ICH reduction from MIS+rt-PA is related to improved functional outcome, as compared to medically treated subjects.

Study Sponsor and Chair:  Daniel F. Hanley, MD     Johns Hopkins University
Principal Investigator:        Mario Zuccarello, MD   University of Cincinnati    
Principal Investigator:        Issam Awad, MD            University of Chicago         

Collaborators:

National Institute of Neurological Disorders and Stroke (NINDS), Cooperative Agreement: 1U01NS080824-01A1
Genentech
Emissary International LLC

FDA, IND: #

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