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

Sponsor:

Information provided by (Responsible Party):

W.L.Gore & Associates

Study Description

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

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

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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).

Eligibility Criteria

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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

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

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

Messé SR, Erus G, Bilello M, Davatzikos C, Andersen G, Iversen HK, Roine RO, Sjöstrand C, Rhodes JF, Søndergaard L, Kasner SE; Gore REDUCE Study Investigators. Patent Foramen Ovale Closure Decreases the Incidence but Not the Size of New Brain Infarction on Magnetic Resonance Imaging: An Analysis of the REDUCE Trial. Stroke. 2021 Nov;52(11):3419-3426. doi: 10.1161/STROKEAHA.121.034451. Epub 2021 Aug 30.

Kasner SE, Thomassen L, Søndergaard L, Rhodes JF, Larsen CC, Jacobson J. Patent foramen ovale closure with GORE HELEX or CARDIOFORM Septal Occluder vs. antiplatelet therapy for reduction of recurrent stroke or new brain infarct in patients with prior cryptogenic stroke: Design of the randomized Gore REDUCE Clinical Study. Int J Stroke. 2017 Dec;12(9):998-1004. doi: 10.1177/1747493017701152. Epub 2017 Mar 24.

Søndergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, Settergren M, Sjöstrand C, Roine RO, Hildick-Smith D, Spence JD, Thomassen L; Gore REDUCE Clinical Study Investigators. Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke. N Engl J Med. 2017 Sep 14;377(11):1033-1042. doi: 10.1056/NEJMoa1707404. Erratum in: N Engl J Med. 2020 Mar 5;382(10):978.

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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 Aspirin Dipyridamole Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action

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