Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization



Status:Completed
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2015
End Date:May 2015

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A Prospective Study of the Treatment of Intracranial Aneurysms Using Pipeline Flow-Diverter Embolization in Conjunction With Transcranial Dopplers (TCD)

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.

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.

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
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Gainesville, Florida 32610
(352) 392-3261
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