The findings, says the University of Cincinnati's Joseph Broderick, MD, co-principal investigator of the study, are encouraging and support a much broader phase-3 trial planned to begin soon.
Dr. Broderick, chair of the neurology department at the University of Cincinnati (UC) and co-principal investigator Thomas Tomsick, MD, director of neuroradiology at UC and Cincinnati's University Hospital, presented their findings today at the International Stroke Conference in Kissimmee, Fla. The study was co-sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) and EKOS Corporation.
The study, known as Interventional Management of Stoke Study or IMS-II, involved 73 participants between the ages of 18 and 80 treated in 13 participating centers and suffering from severe ischemic stroke. Each was given lower than standard doses of tissue plasminogen activator (tPA) during a 30-minute period within three hours of the onset of stroke.
Subjects were then immediately taken for an angiography where a microcatheter (small tube) was placed into a groin artery and threaded to the site of the blocked artery in their brain. Twenty-one participants without a visible and treatable clot received no additional therapy. The remainder of participants (52) who had visible, treatable clots was treated with up to 22 milligrams of additional tPA delivered through the catheter directly to the blockage.
Whenever possible, they were also given a low-energy ultrasound treatment at the site of the clot. The ultrasound, which attempted to break up the clot, was administered using the EKOS Micro-Infusion Catheter MicroLysus infusion system. In 18 participants, where the EKOS MicroLysus catheter could not access the clot,
Contact: Sheryl Hilton
University of Cincinnati