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OpenTrials
Completed

NCT Number: NCT02354300

Transcranial Doppler Ultrasound Monitoring During Flow-Diverter Embolization

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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Aneurysm, Intracranial Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Giant Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCD Ultrasound

Device

Transcranial doppler ultrasound monitoring will occur during flow diverter placement.

Other names: TCD

Primary outcomes

  1. Occurence of microemboli

    Time frame: 1 day

    The number of subjects who experience microemboli during device placement.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2015
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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