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

Primary Purpose

Stroke, Transient Ischemic Attack

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Septal Occluder Device
Antiplatelet Medical Therapy
Sponsored by
W.L.Gore & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring cryptogenic, stroke, transient ischemic attack, TIA, PFO, Patent foramen ovale, HELEX, Septal Occluder, PFO Occluder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania Medical Center
  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Medical Management

Device Closure

Arm Description

Antiplatelet medical therapy alone

PFO closure with study septal occluder device plus antiplatelet medical therapy

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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).

Full Information

First Posted
August 19, 2008
Last Updated
October 23, 2020
Sponsor
W.L.Gore & Associates
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1. Study Identification

Unique Protocol Identification Number
NCT00738894
Brief Title
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
Acronym
REDUCE
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2008 (Actual)
Primary Completion Date
April 24, 2017 (Actual)
Study Completion Date
May 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack
Keywords
cryptogenic, stroke, transient ischemic attack, TIA, PFO, Patent foramen ovale, HELEX, Septal Occluder, PFO Occluder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
664 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medical Management
Arm Type
Active Comparator
Arm Description
Antiplatelet medical therapy alone
Arm Title
Device Closure
Arm Type
Experimental
Arm Description
PFO closure with study septal occluder device plus antiplatelet medical therapy
Intervention Type
Device
Intervention Name(s)
Septal Occluder Device
Other Intervention Name(s)
GORE® HELEX® Septal Occluder, GORE® CARDIOFORM Septal Occluder
Intervention Description
PFO closure with study septal occluder device
Intervention Type
Drug
Intervention Name(s)
Antiplatelet Medical Therapy
Other Intervention Name(s)
Aspirin, Dipyridamole, Aggrenox, Clopidogrel, Plavix
Intervention Description
Investigator's choice of one of three regimen options specified in protocol
Primary Outcome Measure Information:
Title
Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)
Description
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.
Time Frame
24 months
Title
Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of Subjects With Study-related Serious Adverse Events
Description
Adverse event seriousness and relationship to study treatments (device, procedure, or antiplatelet medical therapy) as reported by each investigative site
Time Frame
24 months
Title
Number of Subjects With Effective Closure in Test (Device) Arm
Description
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).
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott E. Kasner, MD, FAHA
Organizational Affiliation
University of Pennsylvania Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John F. Rhodes, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Søndergaard, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
34455822
Citation
Messe SR, Erus G, Bilello M, Davatzikos C, Andersen G, Iversen HK, Roine RO, Sjostrand C, Rhodes JF, Sondergaard 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.
Results Reference
derived
PubMed Identifier
29090661
Citation
Kasner SE, Thomassen L, Sondergaard 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.
Results Reference
derived
PubMed Identifier
28902580
Citation
Sondergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, Settergren M, Sjostrand 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.
Results Reference
derived

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

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