GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients (REDUCE)
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ClinicalTrials.gov Identifier: NCT00738894 |
Recruitment Status :
Completed
First Posted : August 21, 2008
Results First Posted : August 9, 2018
Last Update Posted : November 20, 2020
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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 |
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Stroke Transient Ischemic Attack | Device: Septal Occluder Device Drug: Antiplatelet Medical Therapy | Not Applicable |
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 |
Arm | Intervention/treatment |
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Active Comparator: Medical Management
Antiplatelet medical therapy alone
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Drug: Antiplatelet Medical Therapy
Investigator's choice of one of three regimen options specified in protocol
Other Names:
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Experimental: Device Closure
PFO closure with study septal occluder device plus antiplatelet medical therapy
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Device: Septal Occluder Device
PFO closure with study septal occluder device
Other Names:
Drug: Antiplatelet Medical Therapy Investigator's choice of one of three regimen options specified in protocol
Other Names:
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- 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.
- 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).

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

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
United States, Pennsylvania | |
University of Pennsylvania Medical Center | |
Philadelphia, Pennsylvania, United States, 19104 | |
Denmark | |
Rigshospitalet | |
Copenhagen, Denmark |
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 |
Documents provided by W.L.Gore & Associates:
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 |
cryptogenic stroke transient ischemic attack TIA PFO |
Patent foramen ovale HELEX Septal Occluder PFO Occluder |
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 |
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