MISTIE III - A phase III, Randomized, Open Label, 500-Subject Clinical Trial of Minimally Invasive Surgery Plus rt-PA in the Treatment of Intraccebral Hemorrhage
ID Number 13-1608Principal Investigator(s)
Department(s) or Division(s)
MISTIE III will test a minimally invasive surgical procedure in which a hollow tube, called a catheter, is used to remove the blood clot from a bleed in the brain known as an intracerebral hemorrhage (ICH), and to administer a drug called rt-PA (recombinant tissue plasminogen activator) into the blood clot to break it up. rt-PA is used in other areas of the body to break up blood clots, and in fact, is the standard treatment for ischemic stroke (a type of stroke in which a blood vessel is blocked by a clot) and heart attack.
The hope is that the MISTIE procedure will improve participant recovery. Participants in the MISTIE III trial are followed for a year after their ICH to determine if this new surgical procedure and drug will help them recover more fully.
The MISTIE III trial is a phase III clinical trial that will involve people from all over the United States, Canada, Europe, and Asia. The MISTIE procedure and study drug, rt-PA, have already been tested in phase I and II clinical trials.
Primary objective: Demonstrate that minimally invasive surgery (MIS) plus recombinant tissue plasmogen activator (rt-PA) for three days improves functional outcome by a 12% in the modified Rankin Scale (mRS) score 0-3 compared to medically threated subjects assessed at 180 days.
Recruiting Patients: Yes