Clinical Trial: 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)

Study Status: Available
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex® Septal Closure System Versus Best Medical Therapy in Patients With a Stroke and/or Tra

Brief Summary: 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.

Detailed Summary:
Sponsor: NMT Medical

Current Primary Outcome:

  • Two (2) year incidence of stroke or Hard TIA [ Time Frame: 2 years ]
  • All cause mortality for the first 30 days of follow up/discharge, whichever is longer [ Time Frame: 30 days ]
  • Neurological mortality from 31 days of follow up (F/U) or longer [ Time Frame: 31 days ]


Original Primary Outcome:

  • -2 year incidence of stroke or TIA
  • -all cause mortality for the first 30 days of follow up/discharge, whichever is longer
  • Neurological mortality from 31 days of F/U or longer


Current Secondary Outcome:

  • Incidence of primary endpoint as a total and broken down by event type/treatment group in: stroke/TIA patients (pts) and DW-MR+ pts with symptoms < 24 hours [ Time Frame: < 24 hrs ]
  • Incidence of primary endpoint in BMT group [ Time Frame: 2 years ]
  • Per treatment group, incidence of relevant/notable adverse events (AEs) [ Time Frame: 2 years ]
  • Device group: (1) Incidence of primary endpoint in pts prescribed aspirin (325 versus 81 mg) daily, (2) Incidence of relevant/notable AEs [ Time Frame: 2 years ]


Original Secondary Outcome:

  • Incidence of 1* endpoint as a total & broken down by event type/treatment group in:stroke/TIA patients &, DW-MR+ pts with symptoms < 24 hrs
  • Incidence of 1* endpoint in BMT group
  • Per treatment group, incidence of relevant/notable AEs
  • Device group: (1)Incidence of 1* endpoint in pts prescribed aspirin (325 vs 81mg)daily, (2)Incidence of relevant/notable AEs
  • Tertiary: Several others


Information By: NMT Medical

Dates:
Date Received: September 12, 2005
Date Started: June 2003
Date Completion: April 2010
Last Updated: December 29, 2008
Last Verified: November 2008