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NCT01414387 · ClinicalTrials.gov registry record · NA
Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting
A NA study, sponsored by Dallas VA Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT01414387 is a NA study that was terminated before completion, run by Dallas VA Medical Center. The registered enrollment target is 33 participants.
The verdict
NCT01414387, a NA study, was terminated before completion, sponsored by Dallas VA Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study Summary
Carotid artery stenting (CAS) with cerebral embolic protection is the preferred treatment for narrowing of the carotid arteries in patients at high risk for open surgery. Special devices are used to protect the brain from particles(emboli) that may break off when the narrowing or blockage is cleared during the angioplasty and stenting procedure. Although filters are most frequently used, protection systems consisting of balloons and flow reversal are also available for cerebral embolic protection. However, there is little information about the effectiveness of filters compared with balloons and flow reversal for prevention of embolization during CAS. The aim of our study is to address this major problem. Our study was designed to answer two specific questions: First, the study will investigate whether balloon-based protection systems are more effective than filters in reducing the amount of particles that break off and travel to the brain during CAS. For this purpose two imaging techniques will be used: magnetic resonance imaging of the brain (MRI), and transcranial doppler (detection of microparticles in the small brain vessels using ultrasound). Second, it will be investigated whether the use of balloon-based protection devices are more effective than filters for prevention of stroke, heart attacks, and death after carotid stenting. The results of the study will provide important information to find out the best way to protect the brain from plaque fragments that may break off during CAS.
Interventions
- PROCEDURE Carotid filter
- PROCEDURE Carotid reversal of flow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-02-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01414387
The ClinicalTrials.gov registry entry for NCT01414387 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dallas VA Medical Center, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Carotid filter is the first listed.
NCT01414387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01414387 about?
NCT01414387 is a clinical study titled "Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting". Carotid artery stenting (CAS) with cerebral embolic protection is the preferred treatment for narrowing of the carotid arteries in patients at high risk for open surgery. Special devices are used to protect the brain from particles(emboli) that may break off when the narrowing or blockage is cleared...
What is the current status of trial NCT01414387?
This trial is currently terminated. It is a NA study. The enrollment target is 33 participants. The study started on 2011-10. Estimated completion is 2016-02-12.
What interventions are being tested in trial NCT01414387?
The interventions under investigation include: Carotid filter (PROCEDURE), Carotid reversal of flow (PROCEDURE).
Who is sponsoring clinical trial NCT01414387?
This trial is sponsored by Dallas VA Medical Center, which has 20 total clinical trials registered on ClinicalTrials.gov.
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