Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)

Active, not recruiting

Phase 2/3 Results N/A

Summary of Purpose

The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy.

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 29 December 2008.

1 Jun 2003 12 Sep 2005 Unavailable 1 Apr 2010 1 Nov 2008 Unavailable
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment


  • Karen Doyle NMT Medical, Inc 27 Wormwood Street Boston, MA 02210 617-737-0930 Ext. 121 kbd@nmtmedical.com Cathy Sila, MD Phone: (216)444-4230 Email: silac@ccf.org