An observational study in Abdominal Aortic Aneurysm, Endoleak and Stent-Graft Endoleak, sponsored by University of Edinburgh. Completed at 4 sites in United Kingdom. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by University of Edinburgh · Observational
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.
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.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's enrollment of 102 is below the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of individuals with an abdominal aortic aneurysm (AAA). The first part of the study (Study 1 - Case Control Study) will recruit patients with existing EVAR in to two groups: patients that have an endoleak or related complication (endoleak group, n = 22) and those that have remained complication-free (no endoleak group, n = 22). We will also prospectively recruit patients who are yet to receive EVAR or fenestrated EVAR (pre-EVAR group, n = 100) for the (Study 2 - Cohort Study).
There will be four patient identification centres from which patients will be recruited: NHS Lothian, NHS Lanarkshire, NHS Greater Glasgow and Clyde, and NHS Tayside.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with a previous Endovascular Aneurysm Repair (EVAR) who have developed an endoleak
Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography · Diagnostic Test: CT Aortic Angiogram
Participants with a previous Endovascular Aneurysm Repair (EVAR) who have not developed an endoleak
Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography · Diagnostic Test: CT Aortic Angiogram
Participants who have an abdominal aortic aneurysm and who are undergoing an Endovascular Aneurysm Repair as standard of care
Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography · Diagnostic Test: 12-month CT Aortic Angiogram · Other: 24-month review
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
CT scan to assess aortic morphology and contextualise PET scan
CT scan to assess aortic morphology and the stent graft
This will consist of a telephone consultation with the study participant and review of electronic clinical records
Microcalcification activity in stented and aneurysmal aorta
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.
Time frame: 12 months
Pattern of microcalcification activity in the stented aorta
Microcalcification activity
Time frame: 12 months
Intensity of microcalcification activity in the stented aorta
Microcalcification activity
Time frame: 12 months
Endoleaks
Computed tomography and ultrasound endpoints
Time frame: 12 months
Stent graft migration
Computed tomography and ultrasound endpoints
Time frame: 12 months
Aneurysm sac diameter
Computed tomography and ultrasound endpoints
Time frame: 12 months
Neck diameter and neck angulation
Computed tomography and ultrasound endpoints
Time frame: 12 months
Geometry: tortuosity, curvature, torsion
Computed tomography and ultrasound endpoints
Time frame: 12 months
Aneurysm-related mortality
Clinical endpoints
Time frame: 24 months
Re-intervention
Clinical endpoints
Time frame: 24 months
All-cause mortality
Clinical endpoints
Time frame: 24 months
Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue
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.
Time frame: 12-36 months
Plan to share: No — There are no plans for individual participant data sharing.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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