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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Device: Septal Occluder Device
* Drug: Antiplatelet Medical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medical Management<br>Antiplatelet medical therapy alone | Drug: Antiplatelet Medical Therapy<br>* Investigator's choice of one of three regimen options specified in protocol<br>* Other names: Plavix;|
| Experimental: Device Closure<br>PFO closure with study septal occluder device plus antiplatelet medical therapy | Device: Septal Occluder Device<br>* PFO closure with study septal occluder device<br>* Other names: GORE® CARDIOFORM Septal Occluder;Drug: Antiplatelet Medical Therapy<br>* Investigator's choice of one of three regimen options specified in protocol<br>* Other names: Plavix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1) | 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. | 24 months | 
| Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2) | 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Study-related Serious Adverse Events | Adverse event seriousness and relationship to study treatments (device, procedure, or antiplatelet medical therapy) as reported by each investigative site | 24 months | 
| Number of Subjects With Effective Closure in Test (Device) Arm | 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). | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryptogenic, stroke, transient ischemic attack, TIA, PFO, Patent foramen ovale, HELEX, Septal Occluder, PFO Occluder