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NCT00738894 · ClinicalTrials.gov registry record · NA
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
A NA study of Stroke and Transient Ischemic Attack, sponsored by W.L.Gore & Associates.
- Completed
- Registry status
- NA
- Development phase
- 664
- Enrollment target
- 2
- Study locations
NCT00738894 is a NA study of Stroke and Transient Ischemic Attack that has completed, run by W.L.Gore & Associates. The registered enrollment target is 664 participants, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00738894, a NA study of Stroke and Transient Ischemic Attack, has completed, sponsored by W.L.Gore & Associates.
- COMPLETED
- Registry status
- NA
- Development phase
- 664 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DEVICE Septal Occluder Device
- DRUG Antiplatelet Medical Therapy
Study Locations (2)
Pennsylvania
- University of Pennsylvania Medical Center - Philadelphia
Other
- Rigshospitalet - Copenhagen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 664 participants |
| Start Date | 2008-12-10 |
| Est. Completion | 2020-05-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00738894
The ClinicalTrials.gov registry entry for NCT00738894 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 664 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (94% lower). The listed sponsor is W.L.Gore & Associates, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Septal Occluder Device is the first listed.
NCT00738894 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Pennsylvania, Other.
Frequently Asked Questions
What is clinical trial NCT00738894 about?
NCT00738894 is a clinical study titled "GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients". 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 (TI...
What is the current status of trial NCT00738894?
This trial is currently completed. It is a NA study. The enrollment target is 664 participants. The study started on 2008-12-10. Estimated completion is 2020-05-11.
What conditions does trial NCT00738894 study?
This clinical trial studies the following conditions: Stroke, Transient Ischemic Attack.
What interventions are being tested in trial NCT00738894?
The interventions under investigation include: Septal Occluder Device (DEVICE), Antiplatelet Medical Therapy (DRUG).
Who is sponsoring clinical trial NCT00738894?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00738894 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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