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A second trial, called Sisters, 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 Crystal AF 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.
Crystal AF will involve approximately 450 cryptogenic stroke or TIA patients without a prior history of AF, at 45 centers in Europe, Canada and the US. The primary objective is to evaluate the time to first documented event of AF following cryptogenic stroke or TIA through six months continuous heart rhythm monitoring using the Medtronic Reveal XT insertable cardiac monitor (continuous monitoring arm) and Medtronic CareLink Network, compared to standard of care optimal medical treatment (control arm). Patients will be followed at one, six and 12 months, and every six months thereafter; results are expected in 2012.
Sisters will involve approximately 88 patients at 20 centers in Europe and the US. The study is a randomized, controlled, multi-center study to compare the effect of ITB Therapy on generalized, severe spasticity in post-stroke patients. The primary objective is to evaluate the effectiveness of ITB Therapy in reducing spasticity compared to best medical therapy in adult post-stroke patients. Other outcomes to be addressed in the study include function, quality of life and cost-effectiveness.
Rick Kuntz, president of the neuromodulation business and senior vice president at Medtronic, said: "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."
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