Clincosm LogoSign in Get a demo

Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Terminated
CT.gov ID
NCT01843335
Collaborator
St. Olavs Hospital (Other), SINTEF Health Research (Other)
30
Enrollment
1
Location
33
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

X-ray computed tomography imaging (CT) is routinely used in follow-up after endovascular aneurysm repair (EVAR). Contrast-enhanced ultrasound (CEUS) has been shown to give accurate information about endoleak after EVAR. Benefits of CEUS over CT include less radiation exposure, avoidance of renal function deterioration due to repeated X-ray contrast agent application and decrease in the cost of EVAR follow-up. This study is designed to investigate if results from literature are reproducible in St Olavs Hospital in Trondheim (Norway), to gain experience with the technique and to introduce CEUS as an alternative for detection of endoleak in this hospital.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair
    Actual Study Start Date :
    Sep 1, 2014
    Actual Primary Completion Date :
    Jun 1, 2017
    Actual Study Completion Date :
    Jun 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Detection of endoleak with CEUS [9 months]

      Compare CEUS with computed tomography angiography (CTA) sensitivity for detection of endoleak

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • in follow-up after endovascular implantation of abdominal aortic prothesis
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Olavs Hospital Trondheim Norway 7006

    Sponsors and Collaborators

    • Norwegian University of Science and Technology
    • St. Olavs Hospital
    • SINTEF Health Research

    Investigators

    • Study Director: Reidar Brekken, PhD, National Taiwan Normal University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT01843335
    Other Study ID Numbers:
    • 2013/359/REKnord
    First Posted:
    Apr 30, 2013
    Last Update Posted:
    Oct 31, 2017
    Last Verified:
    Oct 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Norwegian University of Science and Technology
    Cardiovascular Diagnostic Technique
    Ultrasound
    Additional relevant MeSH terms:
    Aneurysm
    Aortic Aneurysm
    Aortic Aneurysm, Abdominal
    Endoleak

    Study Results

    No Results Posted as of Oct 31, 2017