Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization

August 25, 2016 updated by: University of Florida

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatient clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TCD Ultrasound
Transcranial doppler ultrasound monitoring during flow diverter placement.
Device: TCD Ultrasound
Transcranial doppler ultrasound monitoring will occur during flow diverter placement.
Other Names:
  • TCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of microemboli
Time Frame: 1 day
The number of subjects who experience microemboli during device placement.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Spiros Blackburn, MD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

January 29, 2015

First Posted (Estimate)

February 3, 2015

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201400923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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