Medtronic Inc. announced two significant clinical trials related to medical device interventions for stroke. First enrollments in the global CRYSTAL AF (Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation after Cryptogenic Stroke) trial have taken place. The trial will use the Reveal XT Insertable Cardiac Monitor (ICM) to assess the incidence of atrial fibrillation (AF) in patients with cryptogenic stroke (stroke of an undetermined cause) or transient ischemic attack (TIA) in order to aid physicians in determining the optimal course of treatment for these patients. It is widely recognized that patients with sustained AF are at increased risk of stroke.
A second trial, called SISTERS (Spasticity In Stroke – Randomized Study), is being initiated at centers in Europe and the US to compare the effectiveness of Intrathecal Baclofen (ITB) Therapy to best medical therapy in managing generalized, severe, post-stroke spasticity (tightening of the muscles). This clinical trial is designed to add to the body of clinical evidence for ITB Therapy, which is FDA-approved for the treatment of post-stroke spasticity.
“The clinical trials announced showcase Medtronic’s wide and deep expertise and our commitment to the management of those who have suffered a stroke by reducing its spasticity consequences and maximizing preventive therapy for future strokes,” said Rick Kuntz, M.D., president of the Neuromodulation business and senior vice president at Medtronic. “Stroke is a chronic disease that affects a large population of patients and these two studies seek to provide a higher level of clinical evidence for important medical device interventions that can aid in the diagnosis of stroke as well as the management of intractable spasticity, which is a common outcome of stroke.”