Trial record 1 of 1 for:
NCT00738894
GORE® HELEX® Septal Occluder / GORE® Septal Occluder for Patent Foramen Ovale (PFO) Closure in Stroke Patients - The Gore REDUCE Clinical Study (HLX 06-03)
This study is currently recruiting participants.
Verified March 2013 by W.L.Gore & Associates
Sponsor:
W.L.Gore & Associates
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00738894
First received: August 19, 2008
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
The primary objective is to determine that 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke Transient Ischemic Attack |
Device: GORE® HELEX® Septal Occluder / GORE® Septal Occluder |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by W.L.Gore & Associates:
Primary Outcome Measures:
- Freedom from recurrent ischemic stroke or imaging-confirmed TIA through at least 24 months post-randomization. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety: Adverse events (AEs) directly related to the device, procedure, and/or antiplatelet medical therapy [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Efficacy: Assessment of PFO closure in test (device) arm subjects by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 664 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | January 2018 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Antiplatelet Medical Therapy alone
|
|
|
Experimental: 2
PFO Closure with GORE® HELEX® Septal Occluder / GORE® Septal Occluder Plus Antiplatelet Medical Therapy
|
Device: GORE® HELEX® Septal Occluder / GORE® Septal Occluder
PFO closure with GORE® HELEX® Septal Occluder / GORE® Septal Occluder
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738894
Contacts
| Contact: Don Tunucci | 800-437-8181 ext 45208 | REDUCE@wlgore.com |
Locations
| United States, Pennsylvania | |
| University of Pennsylvania Medical Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Steven Messe, MD | |
| Principal Investigator: Steven Messe, MD | |
| Denmark | |
| Rigshospitalet | Recruiting |
| Copenhagen, Denmark | |
| Contact: Lars Søndergaard, MD | |
| Principal Investigator: Lars Søndergaard, MD | |
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
| Principal Investigator: | Scott E. Kasner, MD, FAHA | University of Pennsylvania Medical Center |
| Principal Investigator: | John F. Rhodes, MD | Duke University |
| Principal Investigator: | Lars Søndergaard, MD | Rigshospitalet, Denmark |
| Principal Investigator: | Lars Thomassen, MD, PhD | Haukeland University Hospital - Bergen, Norway |
More Information
Additional Information:
No publications provided
| Responsible Party: | W.L.Gore & Associates |
| ClinicalTrials.gov Identifier: | NCT00738894 History of Changes |
| Other Study ID Numbers: | HLX 06-03 |
| Study First Received: | August 19, 2008 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by W.L.Gore & Associates:
|
cryptogenic stroke transient ischemic attack TIA PFO |
Patent foramen ovale HELEX Septal Occluder PFO Occluder |
Additional relevant MeSH terms:
|
Ischemic Attack, Transient Foramen Ovale, Patent Heart Septal Defects, Atrial Ischemia Stroke Cerebral Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Heart Septal Defects Heart Defects, Congenital Cardiovascular Abnormalities Heart Diseases Congenital Abnormalities Pathologic Processes Brain Infarction |
ClinicalTrials.gov processed this record on May 23, 2013