Clinical trial NCT00738894: GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Transient Ischemic Attack
Keywords: cryptogenic
stroke
transient ischemic attack
TIA
PFO
Patent foramen ovale
HELEX
Septal Occluder
PFO Occluder
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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® 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

Primary outcomes:
measure: Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)
timeFrame: 24 months
measure: Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2)
timeFrame: 24 months
Secondary outcomes:
measure: Number of Subjects With Study-related Serious Adverse Events
timeFrame: 24 months
measure: Number of Subjects With Effective Closure in Test (Device) Arm
timeFrame: 24 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: University of Pennsylvania Medical Center
name: Scott E. Kasner, MD, FAHA
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: John F. Rhodes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Lars Søndergaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.