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

NCT00738894 | Completed Results DMC

• 1 other identifier: HLX 06-03
• Study Type: interventional
• Target: 664
• Locations: 2 countries
• Sites: 2

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.

Conditions

Stroke; Transient Ischemic Attack

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1)

  A recurrent stroke event was defined as the first occurrence post-randomization of either a) neurological deficit presumed due to ischemia and persisting longer than 24 hours or until death, or b) transient neurological deficit presumed due to ischemia, persisting less than 24 hours with MRI evidence of a new relevant brain infarction.

  24 months

• Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2)

  Responders were subjects who showed one or more new infarctions on MRI since screening, or experienced a confirmed recurrent stroke, through 24 months (913 days). Nonresponders were subjects who did not show new infarction on MRI since screening and were confirmed free of recurrent stroke through at least 549 days. An infarction was defined as a new (since screening) T2 hyperintense MRI lesion with diameter ≥ 3 mm.

  24 months

Secondary Outcomes (2)

• Number of Subjects With Study-related Serious Adverse Events

  24 months

• Number of Subjects With Effective Closure in Test (Device) Arm

  24 months

Study Arms (2)

Medical Management

ACTIVE COMPARATOR

Antiplatelet medical therapy alone

Drug: Antiplatelet Medical Therapy

Device Closure

EXPERIMENTAL

PFO closure with study septal occluder device plus antiplatelet medical therapy

Device: Septal Occluder Device; Drug: Antiplatelet Medical Therapy

Interventions

Septal Occluder Device DEVICE

PFO closure with study septal occluder device

Also known as: GORE® HELEX® Septal Occluder, GORE® CARDIOFORM Septal Occluder

Device Closure

Antiplatelet Medical Therapy DRUG

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

Also known as: Aspirin, Dipyridamole, Aggrenox, Clopidogrel, Plavix

Device Closure; Medical Management

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (2)

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (3)

• 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.

  PMID: 34455822 DERIVED

• 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.

  PMID: 29090661 DERIVED

• 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.

  PMID: 28902580 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Foramen Ovale, Patent

Interventions

Septal Occluder Device; Aspirin; Dipyridamole; Aspirin, Dipyridamole Drug Combination; Clopidogrel

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Bryan Randall
• Organization: W. L. Gore & Associates

BRandall@WLGore.com

928-864-4832

Study Officials

• Scott E. Kasner, MD, FAHA

  University of Pennsylvania Medical Center

  PRINCIPAL INVESTIGATOR

• John F. Rhodes, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Lars Søndergaard, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 21, 2008
• Study Start: December 10, 2008
• Primary Completion: April 24, 2017
• Study Completion: May 11, 2020
• Last Updated: November 20, 2020
• Results First Posted: August 9, 2018

Record last verified: 2020-10

Locations

DK (1); US (1)