Condition | Neurology

CLOSURE I

  • IRB Number: NMT 910
  • Contact Name: Cheryl Weber, RN, MS, CCRC
  • Status: Open
  • Phone: 585-922-4111
  • Lead Researcher: W. Scott Burgin, MD

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.