Device Studies

Name of Trial: CLOSURE I - Evaluation of the STARFlex® Septal Closure System in Patients with a Stroke and/or transient ischemic attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale
CPHS #: 16378

Start date: August 2003

End date: December 2006

Description of Trial: A prospective, multicenter, randomized controlled trial with the primary objective to determine whether the STARFlex® Septal Closure System (STARFlex) will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a patent foramen ovale (PFO) and to demonstrate superiority of the STARFlex device compared to best medical therapy.