Clinical trial

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

NCT00738894 · W.L.Gore & Associates, Industry · Completed

Key facts

NCT number NCT00738894
Title GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
Official title 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
Acronym REDUCE
Lead sponsor W.L.Gore & Associates, Industry
Status Completed
Study type Interventional
Conditions Stroke, Transient Ischemic Attack
Intervention type Device, Drug
Interventions Septal Occluder Device, Antiplatelet Medical Therapy
Enrollment 664
Start date Dec 10, 2008
Primary completion Apr 24, 2017
Completion May 11, 2020
First posted Aug 21, 2008
Last update posted Nov 20, 2020
Countries Denmark, United States

At a glance

  • 1–9 Study sites
  • Yes Results posted
  • 1–9 Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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