NCT02354300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

January 29, 2015

Last Update Submit

August 25, 2016

Conditions

Intracranial AneurysmAneurysm, IntracranialGiant Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Occurence of microemboli

    The number of subjects who experience microemboli during device placement.

    1 day

Study Arms (1)

TCD Ultrasound

Transcranial doppler ultrasound monitoring during flow diverter placement.

Device: TCD Ultrasound

Interventions

TCD UltrasoundDEVICE

Transcranial doppler ultrasound monitoring will occur during flow diverter placement.

Also known as: TCD
TCD Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient clinic

You may qualify if:

  • Adult subjects 18 years of age and older
  • Non-pregnant
  • Diagnosis of intracranial aneurysm that will be clinically treated with a flow diverter

You may not qualify if:

  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Spiros Blackburn, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

February 3, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

August 26, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)