Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization

University of Florida

Status: Completed

Conditions: Intracranial Aneurysm; Giant Intracranial Aneurysm; Aneurysm, Intracranial

Treatments: Device: TCD Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT02354300

201400923

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2 participants in 1 patient group

TCD Ultrasound

Description:

Transcranial doppler ultrasound monitoring during flow diverter placement.

Treatment:

Device: TCD Ultrasound