GORE® HELEX® Septal Occluder / GORE® Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients - The Gore REDUCE Clinical Study - Full Text View

Purpose

The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder / GORE® 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	Intervention
Stroke Transient Ischemic Attack	Device: GORE® HELEX® Septal Occluder / GORE® Septal Occluder Other: Antiplatelet Medical Therapy


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment
Official Title:	GORE® HELEX® Septal Occluder / GORE® Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale (PFO)

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:

Freedom from recurrent ischemic stroke or imaging-confirmed TIA through at least 24 months post-randomization. [ Time Frame: 24 months ]
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:

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


Estimated Enrollment:	664
Study Start Date:	August 2008
Estimated Study Completion Date:	February 2020
Primary Completion Date:	April 24, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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® Septal Occluder Plus Antiplatelet Medical Therapy	Device: GORE® HELEX® Septal Occluder / GORE® Septal Occluder PFO closure with GORE® HELEX® Septal Occluder / GORE® Septal Occluder Other Names: GORE® HELEX® Septal Occluder GORE® 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

Eligibility


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® 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738894

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


Responsible Party:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT00738894 History of Changes
Other Study ID Numbers:	HLX 06-03
Study First Received:	August 19, 2008
Last Updated:	June 20, 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

ClinicalTrials.gov processed this record on June 28, 2017

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