Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3

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Brief Title

Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3

Official Title

Contrast Enhanced Ultrasound Endoleak Detection Compared To Time-Resolved Computer Tomography Angiography in High Risk Endovascular Aneurysm Repair (EVAR) Surveillance Patients.

Brief 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.

Detailed Description

      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.

      Collected data will be analysed regarding two novel hypothesised methods of using CEUS
      information:

      The first is recording temporal delay between contrast in graft and contrast in endoleak to
      define endoleak type. Potentially this could be used as a faster method of defining endoleak
      type in a surveillance programme.

      The second is to identify/refute correlation between CEUS contrast to appear in endoleak vs
      tCTA contrast to appear in endoleak. If an association can be established, CEUS timings could
      potentially then be used to time 'standard' CTA phases to improve CTAs diagnostic accuracy.

Study Type

Observational

Primary Outcome

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

Secondary Outcome

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

Condition

Endoleak

Intervention

time-resolved CT Angiography

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Radiation

Estimated Enrollment

30

Start Date

January 20, 2016

Completion Date

March 20, 2018

Primary Completion Date

March 20, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Aged 18 or over

          2. Able to give informed consent

          3. Undergone an EVAR of infra-renal abdominal aortic aneurysm

          4. Planned for CTA of EVAR

        Exclusion Criteria:

          1. Unable to receive CTA Contrast Allergy, Insufficient renal function for standard
             outpatient contrast study (eGFR <45) Overactive thyroid gland

          2. 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

          3. Previous embolization of artery in region of EVAR (affects imaging quality)

          4. BMI >30 (affects imaging quality)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Srinivasa R Vallabhaneni, MD, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT02688751

Organization ID

5083

Secondary IDs

15/NW/0908

Responsible Party

Sponsor

Study Sponsor

Liverpool University Hospitals NHS Foundation Trust

Study Sponsor

Srinivasa R Vallabhaneni, MD, Study Chair, Liverpool University Hospitals NHS Foundation Trust

Verification Date

September 2016