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