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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00738894
First received: August 19, 2008
Last updated: August 15, 2017
Last verified: August 2017
August 19, 2008
August 15, 2017
August 2008
April 24, 2017   (Final data collection date for primary outcome measure)
  • 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 ]
Freedom from recurrent ischemic stroke, imaging-confirmed TIA, or death due to stroke through 24 months post-randomization. [ Time Frame: 24 months ]
Complete list of historical versions of study NCT00738894 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients - The Gore REDUCE Clinical Study
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 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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Transient Ischemic Attack
  • 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
  • Active Comparator: 1
    Antiplatelet Medical Therapy Alone
    Intervention: Other: Antiplatelet Medical Therapy
  • Experimental: 2
    PFO Closure with GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder Plus Antiplatelet Medical Therapy
    Interventions:
    • Device: GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder
    • Other: Antiplatelet Medical Therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
664
February 2020
April 24, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   United States
 
 
NCT00738894
HLX 06-03
Yes
Not Provided
Not Provided
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
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
W.L.Gore & Associates
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP