Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride (PET-EVAR)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    144
  • sponsor
    University of Edinburgh
Updated on 23 May 2022
aortic aneurysm
aneurysm repair
ct scan

Summary

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.

Description

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.

Details
Condition Abdominal Aortic Aneurysm, Endoleak, Stent-Graft Endoleak
Treatment 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, CT Aortic Angiogram, 12-month CT Aortic Angiogram, 24-month review
Clinical Study IdentifierNCT04577716
SponsorUniversity of Edinburgh
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

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
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