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Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02354300
Collaborator
(none)
2
Enrollment
1
Location
30
Duration (Days)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TCD Ultrasound

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 Design

Study Type:
Observational
Actual Enrollment :
2 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Prospective Study of the Treatment of Intracranial Aneurysms Using Pipeline Flow-Diverter Embolization in Conjunction With Transcranial Dopplers (TCD)
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Occurence of microemboli [1 day]

      The number of subjects who experience microemboli during device placement.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT02354300
    Other Study ID Numbers:
    • 201400923
    First Posted:
    Feb 3, 2015
    Last Update Posted:
    Aug 26, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Intracranial Aneurysm
    Aneurysm

    Study Results

    No Results Posted as of Aug 26, 2016