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

NCT ID: NCT00738894

Last Updated: 2020-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

664 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-10

Study Completion Date

2020-05-11

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Transient Ischemic Attack

Keywords

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cryptogenic stroke transient ischemic attack TIA PFO Patent foramen ovale HELEX Septal Occluder PFO Occluder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Medical Management

Antiplatelet medical therapy alone

Group Type ACTIVE_COMPARATOR

Antiplatelet Medical Therapy

Intervention Type DRUG

Investigator's choice of one of three regimen options specified in protocol

Device Closure

PFO closure with study septal occluder device plus antiplatelet medical therapy

Group Type EXPERIMENTAL

Septal Occluder Device

Intervention Type DEVICE

PFO closure with study septal occluder device

Antiplatelet Medical Therapy

Intervention Type DRUG

Investigator's choice of one of three regimen options specified in protocol

Interventions

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Septal Occluder Device

PFO closure with study septal occluder device

Intervention Type DEVICE

Antiplatelet Medical Therapy

Investigator's choice of one of three regimen options specified in protocol

Intervention Type DRUG

Other Intervention Names

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GORE® HELEX® Septal Occluder GORE® CARDIOFORM Septal Occluder Aspirin Dipyridamole Aggrenox Clopidogrel Plavix

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott E. Kasner, MD, FAHA

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania Medical Center

John F. Rhodes, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Lars Søndergaard, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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United States Denmark

References

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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.

Reference Type DERIVED
PMID: 34455822 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29090661 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28902580 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HLX 06-03

Identifier Type: -

Identifier Source: org_study_id