Aneurysm, Intracranial, Giant Intracranial Aneurysm, Intracranial Aneurysm
Conditions
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.
Interventions
DEVICETCD Ultrasound
Transcranial doppler ultrasound monitoring will occur during flow diverter placement.
Sponsors
University of Florida
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of microemboli | 1 day | The number of subjects who experience microemboli during device placement. |
Countries
United States
Outcome results
None listed