Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization

Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354300
• Other study ID #: 201400923
• Status: Completed
• Phase: N/A
• First received: January 29, 2015
• Last updated: August 25, 2016
• Start date: April 2015
• Est. completion date: May 2015

Study information

• Verified date: August 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Intracranial
• Giant Intracranial Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• TCD Ultrasound
Transcranial doppler ultrasound monitoring will occur during flow diverter placement.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of microemboli	The number of subjects who experience microemboli during device placement.	1 day	No