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NCT00465270 · ClinicalTrials.gov registry record · NA
Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 980
- Enrollment target
NCT00465270: Completed NA study, sponsored by Abbott Medical Devices.
NCT00465270 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 980 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00465270, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 980 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
Primary Outcome
Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct. Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after r
Interventions
- DEVICE AMPLATZER PFO Occluder
- OTHER Standard of Care - Medical Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 980 participants |
| Start Date | 2003-08 |
| Est. Completion | 2016-05 |
| Phase | NA |
What the finished NCT00465270 record still lists
NCT00465270 is an interventional study that assigns participants to a tested intervention. The registered 980 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which AMPLATZER PFO Occluder is the first listed.
NCT00465270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00465270 about?
NCT00465270 is a clinical study titled "Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial". The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
What is the current status of trial NCT00465270?
This trial is currently completed. It is a NA study. The enrollment target is 980 participants. The study started on 2003-08. Estimated completion is 2016-05.
What interventions are being tested in trial NCT00465270?
The interventions under investigation include: AMPLATZER PFO Occluder (DEVICE), Standard of Care - Medical Management (OTHER).
Who is sponsoring clinical trial NCT00465270?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00465270's enrollment target sits among peer trials
980 122nd of 2000 higher than 1,879 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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