Overview

This trial is active, not recruiting.

Conditions stroke, transient ischemic attack
Treatments gore® helex® septal occluder / gore® septal occluder, antiplatelet medical therapy
Phase phase 3
Sponsor W.L.Gore & Associates
Start date August 2008
End date February 2017
Trial size 664 participants
Trial identifier NCT00738894, HLX 06-03

Summary

The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder / GORE® 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Antiplatelet Medical Therapy Alone
antiplatelet medical therapy Aspirin
Investigator's choice of one of three regimen options specified in protocol
(Experimental)
PFO Closure with GORE® HELEX® Septal Occluder / GORE® Septal Occluder Plus Antiplatelet Medical Therapy
gore® helex® septal occluder / gore® septal occluder GORE® HELEX® Septal Occluder
PFO closure with GORE® HELEX® Septal Occluder / GORE® Septal Occluder
antiplatelet medical therapy Aspirin
Investigator's choice of one of three regimen options specified in protocol

Primary Outcomes

Measure
Freedom from recurrent ischemic stroke or imaging-confirmed TIA through at least 24 months post-randomization.
time frame: 24 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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® Septal Occluder - Need for concomitant procedure(s) that may confound detection of adverse events related to device placement - Note: Additional Exclusion Criteria may apply

Additional Information

Official title GORE® HELEX® Septal Occluder / GORE® Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale (PFO)
Principal investigator Scott E. Kasner, MD, FAHA
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by W.L.Gore & Associates.