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GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients (REDUCE)

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ClinicalTrials.gov Identifier: NCT00738894
Recruitment Status : Active, not recruiting
First Posted : August 21, 2008
Results First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

August 19, 2008
August 21, 2008
May 16, 2018
August 9, 2018
August 9, 2018
August 2008
April 24, 2017   (Final data collection date for primary outcome measure)
  • Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1) [ Time Frame: 24 months ]
    A recurrent stroke event was defined as the first occurrence post-randomization of either a) neurological deficit presumed due to ischemia and persisting longer than 24 hours or until death, or b) transient neurological deficit presumed due to ischemia, persisting less than 24 hours with MRI evidence of a new relevant brain infarction.
  • Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2) [ Time Frame: 24 months ]
    Responders were subjects who showed one or more new infarctions on MRI since screening, or experienced a confirmed recurrent stroke, through 24 months (913 days). Nonresponders were subjects who did not show new infarction on MRI since screening and were confirmed free of recurrent stroke through at least 549 days. An infarction was defined as a new (since screening) T2 hyperintense MRI lesion with diameter ≥ 3 mm.
Freedom from recurrent ischemic stroke, imaging-confirmed TIA, or death due to stroke through 24 months post-randomization. [ Time Frame: 24 months ]
Complete list of historical versions of study NCT00738894 on ClinicalTrials.gov Archive Site
  • Number of Subjects With Study-related Serious Adverse Events [ Time Frame: 24 months ]
    Adverse event seriousness and relationship to study treatments (device, procedure, or antiplatelet medical therapy) as reported by each investigative site
  • Number of Subjects With Effective Closure in Test (Device) Arm [ Time Frame: 24 months ]
    Assessment of PFO closure in test (device) arm subjects by transesophageal echocardiography (TEE) at 24-month follow-up. Effective closure defined as occluded, small, or moderate shunt (0-25 bubbles).
  • Safety: Adverse events (AEs) directly related to the device, procedure, and/or antiplatelet medical therapy [ Time Frame: 24 months ]
  • Efficacy: Assessment of PFO closure in test (device) arm subjects by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) [ Time Frame: 24 months ]
Not Provided
Not Provided
 
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale (PFO) - The Gore REDUCE Clinical Study

The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA.

A co-primary objective is to demonstrate that medical management plus closure with the study device reduces the risk of new brain infarct compared to medical management alone.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Transient Ischemic Attack
  • Device: Septal Occluder Device
    PFO closure with study septal occluder device
    Other Names:
    • GORE® HELEX® Septal Occluder
    • GORE® CARDIOFORM Septal Occluder
  • Drug: Antiplatelet Medical Therapy
    Investigator's choice of one of three regimen options specified in protocol
    Other Names:
    • Aspirin
    • Dipyridamole
    • Aggrenox
    • Clopidogrel
    • Plavix
  • Active Comparator: Medical Management
    Antiplatelet medical therapy alone
    Intervention: Drug: Antiplatelet Medical Therapy
  • Experimental: Device Closure
    PFO closure with study septal occluder device plus antiplatelet medical therapy
    Interventions:
    • Device: Septal Occluder Device
    • Drug: Antiplatelet Medical Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
664
Same as current
February 2020
April 24, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presence of cryptogenic ischemic stroke or TIA of presumed embolic infarction verified by a neurologist within 180 days prior to randomization
  • Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
  • Absence of an identifiable source of thromboembolism in the systemic circulation
  • No evidence of a hypercoagulable state
  • Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

  • Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, atrial fibrillation/flutter, cardiac prosthetics (valves), mitral valve stenosis, aortic dissection, significant atherosclerosis, vasculitis, pre-existing neurologic disorders, multiple sclerosis, arteriovenous malformations, prior intracranial hemorrhage, severe central nervous system (CNS) disease, severe disability related to prior stroke, and autoimmune disorders that would increase the risk of mortality or morbidity above what is typical for the treatment
  • Previous Myocardial Infarction
  • Active infection that cannot be treated successfully prior to randomization
  • Sensitivity or contraindication to all proposed medical treatments
  • Pregnancy or intent on becoming pregnant through 24-months after randomization
  • Indications outside the parameters accepted for placement of the GORE® HELEX® Septal Occluder / GORE® Septal Occluder, including extensive congenital cardiac anomalies and defect diameter estimated to be > 18mm
  • Atrial septal anatomy that is expected to necessitate placement of more than one GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder
  • Need for concomitant procedure(s) that may confound detection of adverse events related to device placement
  • 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
Denmark,   United States
 
 
NCT00738894
HLX 06-03
Yes
Not Provided
Not Provided
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: Scott E. Kasner, MD, FAHA University of Pennsylvania Medical Center
Principal Investigator: John F. Rhodes, MD Medical University of South Carolina
Principal Investigator: Lars Søndergaard, MD Rigshospitalet, Denmark
W.L.Gore & Associates
July 2018

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