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

NCT00738894 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 664

Last updated 2020-11-20

Study results available
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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

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

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Principal Investigators

  • Scott E. Kasner, MD, FAHA · University of Pennsylvania Medical Center

  • John F. Rhodes, MD · Medical University of South Carolina

  • Lars Søndergaard, MD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-10
Primary Completion
2017-04-24
Completion
2020-05-11

Countries

  • United States
  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00738894 on ClinicalTrials.gov