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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00738894
Recruitment Status : Completed
First Posted : August 21, 2008
Results First Posted : August 9, 2018
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stroke Transient Ischemic Attack Device: Septal Occluder Device Drug: Antiplatelet Medical Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 664 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 10, 2008
Actual Primary Completion Date : April 24, 2017
Actual Study Completion Date : May 11, 2020
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Medical Management
Antiplatelet medical therapy alone
 Drug: Antiplatelet Medical Therapy
Investigator's choice of one of three regimen options specified in protocol
Other Names:
  • Aspirin
  • Dipyridamole
  • Aggrenox
  • Clopidogrel
  • Plavix
Experimental: Device Closure
PFO closure with study septal occluder device plus antiplatelet medical therapy
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. 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

  2. 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).



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738894


Locations
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United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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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
  Study Documents (Full-Text)

Documents provided by W.L.Gore & Associates:
Study Protocol  [PDF] January 15, 2016
Statistical Analysis Plan  [PDF] January 15, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00738894    
Other Study ID Numbers: HLX 06-03
First Posted: August 21, 2008    Key Record Dates
Results First Posted: August 9, 2018
Last Update Posted: November 20, 2020
Last Verified: October 2020
Keywords provided by W.L.Gore & Associates:
cryptogenic
stroke
transient ischemic attack
TIA
PFO
 Patent foramen ovale
HELEX
Septal Occluder
PFO Occluder
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Foramen Ovale, Patent
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
 Congenital Abnormalities
Dipyridamole
Clopidogrel
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Phosphodiesterase Inhibitors
Vasodilator Agents