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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738894
• Other study ID #: HLX 06-03
• Status: Completed
• Phase: N/A
• Start date: December 10, 2008
• Est. completion date: May 11, 2020

Study information

• Verified date: October 2020
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: May 11, 2020
• Est. primary completion date: April 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Device:
• Septal Occluder Device
PFO closure with study septal occluder device

Drug:
• Antiplatelet Medical Therapy
Investigator's choice of one of three regimen options specified in protocol

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

United States,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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