The last patient has now completed in Stage II of the phase II MISTIE trial and the final patient in the endoscopy tier should reach the one-year follow-up endpoint next spring. We now turn to data analysis and publication of final results in this trial of minimally-invasive approaches to intracerebral hemorrhage (ICH). Meanwhile, we are already on the road to a phase III trial!
A grant application was submitted to NINDS back in February. After responding to reviewer critiques, we re-submitted earlier this month and now eagerly await a final decision. If the grant is awarded in July-2013, we would begin initiating sites and enrolling patients again by next fall. MISTIE III is planned as a 500-patient randomized clinical trial at approximately 90 international sites. The primary aim is to assess whether rapid removal of intracerebral blood, using intermittent minimally-invasive catheter delivery of a thrombolytic drug, improves functional outcome of patients with an intracerebral hemorrhage (ICH).
MISTIE is an abbreviation for Minimally Invasive Surgery Plus rt-PA for intracerebral Hemorrhage Evacuation. ICH occurs in 100,000 Americans each year and it is the only form of stroke with no effective treatment. This bleeding into the brain matter, usually arising from uncontrolled hypertension, is fatal 30% to 50% of the time and the majority of survivors are left with significant physical and mental disability often having to remain in extended care indefinitely. Compared to ischemic stroke, ICH occurs in younger patients and ICH patients often spend weeks or even months in the hospital with a corresponding high impact in terms of medical and societal costs.
Recognizing this critical unmet medical need, Dr. Daniel F. Hanley initiated the MISTIE program in the 1990's and established the Brain Injury Outcomes (BIOS) division within Johns Hopkins University's Department of Neurology. Over the ensuing years, dozens of top medical centers around the world have joined in this long-term goal to change the way we treat ICH, that is to reduce brain injury using innovative surgical and clinical approaches. The MISTIE II trial was a successful proof-of-concept that has demonstrated the general safety of this new treatment and that has shown very promising improvements in post-stroke recovery. MISTIE III will be a larger trial to definitively establish whether this approach actually does reduce mortality and improve the quality of life of patients after an ICH.
With the grant having now been submitted, we have already begun the process of qualifying sites for MISTIE III. Over the next few months we will begin uploading training courses and other study materials so that we can launch the trial quickly next fall.
One of these early tasks has been to create a new logo for the phase III study. We are happy to premiere this new logo today. Once again employing the "MISTIE Green" theme, this new logo incorporates the clot targeting image that became such an important part of the phase II trial. In that trial, we learned that placement of the catheter along the long axis about 2/3rds of the way into the clot was ideal for delivering the thrombolytic agent. Good catheter placement leads to more effective clot reduction, which the early trial data suggests leads to better long-term recovery. Look for publication of the detailed study results soon!