N/A
N=664
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
Stroke · Transient Ischemic Attack
Bottom Line
View on ClinicalTrials.gov: NCT00738894 ↗Enrolled (actual)
664
Serious AEs
24.7%
Results posted
Aug 2018
Primary outcome: Primary: Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1) — 6; 12 Participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Septal Occluder Device (Device); Antiplatelet Medical Therapy (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Freedom From Recurrent Ischemic Stroke (Primary Outcome #1) |
6; 12 | 0.001 sig |
| PRIMARY Number of Subjects With New Brain Infarct or Recurrent Stroke (Primary Outcome #2) |
22; 20 | 0.024 sig |
| SECONDARY Number of Subjects With Study-related Serious Adverse Events |
102; 62 | — |
| SECONDARY Number of Subjects With Effective Closure in Test (Device) Arm |
312 | — |
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
Data sourced from ClinicalTrials.gov (NCT00738894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.