NCT02354300

Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Aneurysm
• Aneurysm, Intracranial
• Giant Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	TCD Ultrasound	Transcranial doppler ultrasound monitoring will occur during flow diverter placement.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2015-02-03
• Last updated: 2016-08-26

Locations

1 site across 1 country: United States