Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization
- Conditions
- Aneurysm, IntracranialIntracranial AneurysmGiant 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
- Adult subjects 18 years of age and older
- Non-pregnant
- Diagnosis of intracranial aneurysm that will be clinically treated with a flow diverter
- Pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TCD Ultrasound TCD Ultrasound Transcranial doppler ultrasound monitoring during flow diverter placement.
- Primary Outcome Measures
Name Time Method Occurence of microemboli 1 day The number of subjects who experience microemboli during device placement.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States