CompletedNot Applicable

Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3

United Kingdom30 participantsStarted 2016-01-20

Plain-language summary

A single site cross-sectional comparison of paired diagnostic imaging modalities. This study will show the sensitivity and specificity of CEUS in detecting the various types of endoleaks, in comparison to tCTA, following EVAR. It will collect data to allow comparison of diagnostic accuracy across modalities including CDU, CEUS and tCTA. It will collect time taken to perform the various types of scan, to allow healthcare costs to be calculated for each imaging modality.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Aged 18 or over
✓. Able to give informed consent
✓. Undergone an EVAR of infra-renal abdominal aortic aneurysm
✓. Planned for CTA of EVAR

Exclusion criteria

✕. Unable to receive CTA Contrast Allergy, Insufficient renal function for standard outpatient contrast study (eGFR \<45) Overactive thyroid gland
✕. Unable to receive CEUS contrast Previous reaction to Sonovue (Ultrasound Contrast) Allergy to sulphur hexafluoride (used in electrical industry in circuit breakers, switch gears \& electrical equipment) Recent acute coronary syndrome or unstable angina, typical angina at rest or frequent or repeated angina/chest pain - all within previous 7 days Recent coronary intervention
✕. Previous embolization of artery in region of EVAR (affects imaging quality)
✕. BMI \>30 (affects imaging quality)

What they're measuring

Ability to detect type I/III endoleak on CEUS as defined by presence/absence on tCTA

Timeframe: Immediate

Trial details

NCT IDNCT02688751

SponsorLiverpool University Hospitals NHS Foundation Trust

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2018-03-20

View on ClinicalTrials.gov More Endoleak trials