NCT00738894

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 664 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Septal Occluder Device	PFO closure with study septal occluder device
DRUG	Antiplatelet Medical Therapy	Investigator's choice of one of three regimen options specified in protocol

Timeline

• Start date: 2008-12-10
• Primary completion: 2017-04-24
• Completion: 2020-05-11
• First posted: 2008-08-21
• Last updated: 2020-11-20
• Results posted: 2018-08-09

Locations

2 sites across 2 countries: United States, Denmark