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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by NMT Medical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NMT Medical
ClinicalTrials.gov Identifier:
NCT00201461
First received: September 12, 2005
Last updated: December 29, 2008
Last verified: November 2008

September 12, 2005
December 29, 2008
June 2003
Not Provided
  • Two (2) year incidence of stroke or Hard TIA [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • All cause mortality for the first 30 days of follow up/discharge, whichever is longer [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Neurological mortality from 31 days of follow up (F/U) or longer [ Time Frame: 31 days ] [ Designated as safety issue: Yes ]
  • -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 ] [ Designated as safety issue: Yes ]
  • Incidence of primary endpoint in BMT group [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Per treatment group, incidence of relevant/notable adverse events (AEs) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • -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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Active, not recruiting
900
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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00201461
G980031, CLOSURE I
Yes
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