GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients - The Gore REDUCE Clinical Study (HLX 06-03)

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 / 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: GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder; Other: Antiplatelet Medical Therapy	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated 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)
Study Start Date :	August 2008
Actual Primary Completion Date :	April 24, 2017
Estimated Study Completion Date :	February 2020

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 1; Antiplatelet Medical Therapy Alone	Other: Antiplatelet Medical Therapy; Investigator's choice of one of three regimen options specified in protocol; Other Names: Aspirin; Dipyridamole; Aggrenox; Clopidogrel; Plavix
Experimental: 2; PFO Closure with GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder Plus Antiplatelet Medical Therapy	Device: GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder; PFO closure with GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder; Other Names: GORE® HELEX® Septal Occluder; GORE® CARDIOFORM Septal Occluder Other: 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. Freedom from recurrent ischemic stroke or imaging-confirmed TIA through at least 24 months post-randomization. [ Time Frame: 24 months ]
2. Incidence of subjects with new brain infarct or clinical findings of ischemic stroke from screening through 24 months or last follow-up visit, whichever occurs first. [ Time Frame: 24 months ]

Secondary Outcome Measures :

1. Safety: Adverse events (AEs) directly related to the device, procedure, and/or antiplatelet medical therapy [ Time Frame: 24 months ]
2. Efficacy: Assessment of PFO closure in test (device) arm subjects by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) [ Time Frame: 24 months ]

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

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Locations

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

Principal Investigator:	Scott E. Kasner, MD, FAHA	University of Pennsylvania Medical Center
Principal Investigator:	John F. Rhodes, MD	Duke University
Principal Investigator:	Lars Søndergaard, MD	Rigshospitalet, Denmark
Principal Investigator:	Lars Thomassen, MD, PhD	Haukeland University Hospital - Bergen, Norway

More Information

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

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.

Responsible Party:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT00738894 History of Changes
Other Study ID Numbers:	HLX 06-03
First Posted:	August 21, 2008
Last Update Posted:	August 18, 2017
Last Verified:	August 2017

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:

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