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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: Completed NA study of Stroke and Transient Ischemic Attack, sponsored by W.L.Gore & Associates.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A recurrent stroke event was defined as the first occurrence post-randomization of either a) neurological deficit presumed due to ischemia and persisting longer than 24 hours or until death, or b) transient neurological deficit presumed due to ischemia, persisting less than 24 hours with MRI evidence of a new relevant brain infarction.
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 |
What the finished NCT00738894 record still lists
NCT00738894 is an interventional study that assigns participants to a tested intervention. The registered 664 participants enrollment target is mid-sized for trials with a published cap, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00738894's enrollment target sits among peer trials
664 45th of 454 higher than 410 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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