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Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization

Completed
Conditions
Aneurysm, Intracranial
Intracranial Aneurysm
Giant Intracranial Aneurysm
Interventions
Device: TCD Ultrasound
Registration Number
NCT02354300
Lead Sponsor
University of Florida
Brief Summary

Flow diverters have been approved since 2012 for the treatment of large, wide neck intracranial aneurysms. These devices have been associated with embolic events which cause blockage in a blood vessel and can result in long term complications. One possible cause of these events is the formation of small emboli during placement of the device.

Detailed Description

Flow diverters have been developed to treat intracranial aneurysms. Embolisms have occurred in a small percentage of patients which can result in long term complications including stroke, hemorrhage, and even death.

The formation of microemboli during the insertion of the device has not been evaluated. During insertion, there is significant disruption of blood flow and this may be a source of intracranial microemboli.

This study will use transcranial doppler ultrasound (TCD) to evaluate the blood flow during the placement of flow diverters to try to determine why these embolic events occur.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2
Inclusion Criteria
  • Adult subjects 18 years of age and older
  • Non-pregnant
  • Diagnosis of intracranial aneurysm that will be clinically treated with a flow diverter
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Exclusion Criteria
  • Pregnant
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
TCD UltrasoundTCD UltrasoundTranscranial doppler ultrasound monitoring during flow diverter placement.
Primary Outcome Measures
NameTimeMethod
Occurence of microemboli1 day

The number of subjects who experience microemboli during device placement.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Florida

🇺🇸

Gainesville, Florida, United States

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