Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization

NCT ID: NCT02354300

Last Updated: 2016-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-05-31

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.

Conditions

Intracranial Aneurysm; Aneurysm, Intracranial; Giant Intracranial Aneurysm

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

TCD Ultrasound

Transcranial doppler ultrasound monitoring during flow diverter placement.

TCD Ultrasound

Intervention Type: DEVICE

Transcranial doppler ultrasound monitoring will occur during flow diverter placement.

Interventions

TCD Ultrasound

Transcranial doppler ultrasound monitoring will occur during flow diverter placement.

Intervention Type: DEVICE

Other Intervention Names

TCD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Spiros Blackburn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

201400923

Identifier Type: -

Identifier Source: org_study_id