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Completed

NCT Number: NCT04577716

Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride

The purpose of the study is to describe Sodium Fluoride uptake (using Positron Emission Tomography-Computed Tomography - PET-CT) following Endovascular Aneurysm Repair (EVAR) and to determine whether Sodium Fluoride PET-CT can predict the development of endoleaks.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ninewells Hospital, Dundee, United Kingdom

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About this study

Abdominal aortic aneurysms are a leading cause of death in the United Kingdom. Surveillance programmes and pre-emptive surgical repair are lifesaving. Traditional open surgical repair is associated with major perioperative morbidity and mortality and there has been a move towards minimally invasive Endovascular Aneurysm Repair (EVAR), which reduces these early risks. However, the cost effectiveness and long-term clinical effectiveness of EVAR is undermined by concerns of durability due to the development of endoleaks and late aneurysm rupture secondary to progression of native aortic aneurysm disease and stent graft failure. It has previously been demonstrated that 18F-Sodium Fluoride Positron Emission Tomography can predict progression of aneurysm disease and is associated with greater rates of abdominal aortic aneurysm expansion and the future risk of rupture or surgical repair.

The investigators here wish to examine whether 18F-Sodium Fluoride on Positron Emission Tomography uptake (i) is increased in patients with endoleaks or related complications, (ii) can prospectively predict the likelihood of developing endoleaks in patients undergoing EVAR, and (ii) is a feasible approach to select patients for EVAR with a reduced future risk of stent graft failure and re-intervention. The investigators believe that there is a compelling scientific rationale for this approach with major translational potential to better select subgroups of patients for EVAR and ultimately improve their outcome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A diagnosis of AAA as defined by the European Society of Vascular Surgery guidelines on the management of aorto-iliac artery aneurysms, and having undergone endovascular repair within the recommended Instructions For Use (IFU) by the manufacturer. ['Endoleak' and 'No Endoleak groups only]
  • Complication will be defined as any type of endoleak or stent graft migration ['Endoleak' group only].
  • A diagnosis of AAA requiring endovascular repair OR a diagnosis of juxtarenal AAA requiring fenestrated endovascular aneurysm repair as defined by the European Society of Vascular surgery guidelines on the management of aorto-iliac artery aneurysms and planned EVAR or fenestrated EVAR surgery. ['pre-EVAR' group only]
  • Minimum age: 50 years. No maximum age.
  • Retain capacity for informed consent

Exclusion criteria

  • The inability of patients to undergo PET/CT scanning
  • Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2)
  • Major or untreated cancer
  • Pregnancy
  • Allergy or contra-indication to iodinated contrast
  • Inability or unwillingness to give informed consent
  • Life-expectancy of less than two years
  • Known history of connective tissue disease

Treatment and study plan

18F Sodium Fluoride Positron Emission Tomography / Computed Tomography

Diagnostic Test

PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan

CT Aortic Angiogram

Diagnostic Test

CT scan to assess aortic morphology and contextualise PET scan

12-month CT Aortic Angiogram

Diagnostic Test

CT scan to assess aortic morphology and the stent graft

24-month review

Other

This will consist of a telephone consultation with the study participant and review of electronic clinical records

Primary outcomes

  1. Microcalcification activity in stented and aneurysmal aorta

    Time frame: 12 months

    Will be measured as 18F Sodium Fluoride binding in the aorta. Uptake will be quantified in Standardised Uptake Values and as a tissue to background ratios.

Secondary outcomes

  1. Pattern of microcalcification activity in the stented aorta

    Time frame: 12 months

    Microcalcification activity

  2. Intensity of microcalcification activity in the stented aorta

    Time frame: 12 months

    Microcalcification activity

  3. Endoleaks

    Time frame: 12 months

    Computed tomography and ultrasound endpoints

  4. Stent graft migration

    Time frame: 12 months

    Computed tomography and ultrasound endpoints

  5. Aneurysm sac diameter

    Time frame: 12 months

    Computed tomography and ultrasound endpoints

  6. Neck diameter and neck angulation

    Time frame: 12 months

    Computed tomography and ultrasound endpoints

  7. Geometry: tortuosity, curvature, torsion

    Time frame: 12 months

    Computed tomography and ultrasound endpoints

  8. Aneurysm-related mortality

    Time frame: 24 months

    Clinical endpoints

  9. Re-intervention

    Time frame: 24 months

    Clinical endpoints

  10. All-cause mortality

    Time frame: 24 months

    Clinical endpoints

Other outcomes

  1. Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue

    Time frame: 12-36 months

    Uptake of 18F-Sodium Fluoride will be identified on PET-CT scans that are acquired as part of the study visit. This will be compared with histological changes in aortic specimens obtained if participant undergoes an open aortic procedure during the study period.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Greater Glasgow and Clyde
  • NHS Lanarkshire
  • NHS Lothian
  • NHS Tayside

Registry information

Official study title

The PET-EVAR Study - Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride

Acronym: PET-EVAR

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2020
Registry last updated
Jul 3, 2025

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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