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CLOSURE I: Prospective, multicenter, randomized, controlled trial to evaluate the safety and efficacy of the Starflex Septal Closure System

Description: CLOSURE I: Prospective, multicenter, randomized, controlled trial to evaluate the safety and efficacy of the Starflex Septal Closure System vs. best medical therapy in patients with a stroke and/or transient ischemic attack due to presumed paradoxical embolism through a patient foramen ovale To compare the STARFlex device and medication group to the medication-alone group in preventing a recurrent stroke or TIA associated with a PFO. Study conducted in up to 120 centers across the U.S. involving about 800 patients – those with stroke or definite clinical TIA within 6 months, without other definable cause.
IRB Number: NMT 910
Status: Enrollment Complete; Intervention Continues
Start Date: September 01, 2005
Principal Name: W. Scott Burgin, MD
Contact Name: Cheryl Weber, RN, MS, CCRC
Phone: 585-922-4111
Alternative Phone: 585-922-4371