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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)

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ClinicalTrials.gov Identifier: NCT00201461
Recruitment Status : Unknown
Verified November 2008 by NMT Medical.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : December 30, 2008
Sponsor:
Information provided by:
NMT Medical

September 12, 2005
September 20, 2005
December 30, 2008
June 2003
Not Provided
  • 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 ]
  • -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
Complete list of historical versions of study NCT00201461 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
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)
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 Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Patent Foramen Ovale
  • Stroke
  • Ischemic Attack, Transient
  • Device: STARFlex septal closure system
    transcatheter placement of STARFlex device to close a patent foramen ovale
  • Drug: Best medical therapy
    aspirin (325 mg daily) and/or warfarin (target INR = 2.5)
  • Active Comparator: 1
    Best medical therapy
    Intervention: Drug: Best medical therapy
  • Experimental: 2
    STARFlex arm
    Intervention: Device: STARFlex septal closure system

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
900
1600
April 2010
Not Provided

Major Inclusion Criteria:

  • Age 18-60 years inclusive.
  • Positive contrast valsalva bubble study by trans-esophageal echocardiogram (TEE) for patent foramen ovale (PFO), with or without atrial septal aneurysm.
  • Stroke or clinically definite TIA (contact study coordinator).
  • Be able to comply with follow up over two years.
  • Be competent to, or have a legal guardian competent to, provide informed consent following full disclosure of risks and benefits of both treatment arms by a study investigator.
  • Venous access capable of accepting a 10F minimum vascular sheath.
  • Have, or be willing to, discontinue hormonal based contraceptive use prior to enrollment and for the term of the study.
  • Has cardiac anatomy based on enrollment echocardiogram that will allow for placement of the implant if randomized to the implant arm.
  • Note: Additional inclusion criteria may apply. Contact study coordinator or principal investigator for details.

Post-randomization - device patients only

  • The size of the PFO (measured by indentation with a soft balloon) must be amenable to selection of a STARFlex device.

Major Exclusion Criteria:

  • Carotid artery stenosis > 50%.
  • Intracranial stenosis > 50% appropriate to symptoms.
  • Complex aortic arch atheroma with high risk features for embolism
  • Aortic arch, carotid or vertebral artery dissection.
  • Mitral or aortic valve stenosis, vegetation, or calcification > 5 mm mitral annular calcification (MAC) thickness.
  • Active pregnancy.
  • Active infections (contact study coordinator).
  • Active infective endocarditis or bacteremia.
  • Prosthetic heart valves in any location.
  • Anterior MI within 3 months of neurological event.
  • Chronic atrial fibrillation
  • Thrombus in, or occluded, venous access route.
  • Contraindication to heparin, aspirin, clopidogrel, or warfarin, or a known medical condition that requires continuous warfarin.
  • Patient enrolled in another investigation study where clinical endpoint interference may occur.
  • Permanent pacemaker or inferior vena cava (IVC) filter.
  • Serum creatinine > 2.0 mg/dL
  • Patients with known vasculitis or neurologic disorder.
  • Baseline modified Rankin score of 3 or more.
  • Hypercoagulopathies requiring long-term warfarin.
  • Note: Additional exclusion criteria may apply.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00201461
G980031
CLOSURE I
Yes
Not Provided
Not Provided
Not Provided
NMT Medical
Not Provided
Principal Investigator: Anthony Furlan, MD Cleveland Clinic Foundation, Cleveland, OH
Principal Investigator: Mark Reisman, MD Swedish Medical Center, Seattle, WA
NMT Medical
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP