FRIDAY, Oct. 25 (HealthDay News) -- Sonothrombolysis using a novel operator-independent ultrasound device plus tissue-type plasminogen activator (tPA) is safe and effective in patients with ischemic stroke caused by proximal intracranial occlusion, according to a study published online Oct. 24 in Stroke.
Andrew D. Barreto, M.D., from University of Texas Health Science Center at Houston, and colleagues conducted an open-label, pilot safety trial in which 20 patients (60 percent male; mean age, 63 years) with ischemic stroke caused by proximal intracranial occlusion received a standard dose of intravenous tPA plus two-hour therapeutic exposure to 2-MHz pulsed-wave ultrasound delivered by a novel operator-independent ultrasound device.
The researchers found that enrolled patients had a median National Institutes of Health Stroke Scale of 15. Pretreatment occlusion sites were 70 percent middle cerebral artery, 15 percent terminal internal carotid artery, and 15 percent vertebral artery. The median time to tPA at the beginning of sonothrombolysis was 22 minutes. The entire two hours of insonation was tolerated by all participants, with no serious adverse effects, including no development of symptomatic intracerebral hemorrhage. The greatest complete recanalization rate was seen in eight of 14 cases of middle cerebral artery occlusions. A modified Rankin scale of 0 to 1 was seen at 90 days in five of 20 patients.
"Sonothrombolysis using a novel, operator-independent device, in combination with systemic tPA, seems safe, and recanalization rates warrant evaluation in a phase III efficacy trial," the authors write.
One author disclosed financial ties to the medical device industry and holds a pertinent patent.
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