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"

Active, not recruiting

Phase N/A Results N/A

Trial Description

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

Conditions

Interventions

  • GORE HELEX Septal Occluder Procedure/Surgery
    Intervention Desc: The GORE HELEX Septal Occluder is the first device of its kind to use ePTFE, a biocompatible material that allows progressive tissue in-growth, to help seal the defect. The GORE HELEX Septal Occluder has been designed to be soft and flexible, conforming to the anatomy of the heart while bridging and covering the defect to stop the shunting of blood between the atria.
  • GORE HELEX™ Septal Occluder Device
    Other Names: GORE HELEX™ Septal Occluder
    Intervention Desc: PFO closure with GORE HELEX™ Septal Occluder
    ARM 1: Kind: Experimental
    Label: 2
    Description: PFO Closure Plus Antiplatelet Medical Therapy
  • GORE® HELEX® Septal Occluder / GORE® Septal Occluder Device
    Other Names: GORE® HELEX® Septal Occluder; GORE® Septal Occluder
    Intervention Desc: PFO closure with GORE® HELEX® Septal Occluder / GORE® Septal Occluder
    ARM 1: Kind: Experimental
    Label: 2
    Description: PFO Closure with GORE® HELEX® Septal Occluder / GORE® Septal Occluder Plus Antiplatelet Medical Therapy
  • Antiplatelet Medical Therapy Other
    Other Names: Aspirin; Dipyridamole; Aggrenox; Clopidogrel; Plavix
    Intervention Desc: Investigator's choice of one of three regimen options specified in protocol
    ARM 1: Kind: Experimental
    Label: 1
    Description: Antiplatelet Medical Therapy Alone
    ARM 2: Kind: Experimental
    Label: 2
    Description: PFO Closure with GORE® HELEX® Septal Occluder / GORE® Septal Occluder Plus Antiplatelet Medical Therapy
  • GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder Device
    Other Names: GORE® HELEX® Septal Occluder; GORE® CARDIOFORM Septal Occluder
    Intervention Desc: PFO closure with GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder
    ARM 1: Kind: Experimental
    Label: 2
    Description: PFO Closure with GORE® HELEX® Septal Occluder / GORE® CARDIOFORM Septal Occluder Plus Antiplatelet Medical Therapy

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two treatment arms, either antiplatelet medical management alone or device closure of the PFO in conjunction with antiplatelet medical management. Patients will be followed to 2 years for theprimary endpoint, and up to 5 years for secondary endpoints.

Outcomes

Type Measure Time Frame Safety Issue
Primary Freedom from recurrent ischemic stroke, imaging-confirmed TIA, or death due to stroke through 24 months post-randomization.
Secondary Safety: Adverse events (AEs) directly related to the device, procedure, and/or antiplatelet medical therapy; Efficacy: Assessment of PFO closure in test (device) arm subjects by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).
Primary Freedom from recurrent ischemic stroke or imaging-confirmed TIA through at least 24 months post-randomization. 24 months No
Secondary Safety: Adverse events (AEs) directly related to the device, procedure, and/or antiplatelet medical therapy 24 months Yes
Secondary Efficacy: Assessment of PFO closure in test (device) arm subjects by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) 24 months No
Primary 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. 24 months

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