Abdominal Aortic AneurysmPET-EVARNCT04577716
Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride
An observational study of Abdominal Aortic Aneurysm and Endoleak, run by University of Edinburgh at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Endoleak, Stent-Graft Endoleak
- What is being tested?
- 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, CT Aortic Angiogram and 12-month CT Aortic Angiogram
- How many people
- 102 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Apr 2021to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Ninewells Hospital
Dundee, DD2 1SG
University Hospital Hairmyres
East Kilbride, G75 8RG
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SB
Queen Elizabeth University Hospital
Glasgow, G51 4TF
About this study
Official title: The PET-EVAR Study - 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.
Read the detailed 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.
- Conditions
- Abdominal Aortic Aneurysm, Endoleak, Stent-Graft Endoleak
- Being tested
- 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, CT Aortic Angiogram, 12-month CT Aortic Angiogram, 24-month review
- Keywords
- EVAR, Endoleak, 18F-Sodium Fluoride, PET
- Medical subject headings
- Aortic Aneurysm, Abdominal, Endoleak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F Sodium Fluoride Positron Emission Tomography / Computed TomographyDiagnostic test
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
CT Aortic AngiogramDiagnostic test
CT scan to assess aortic morphology and contextualise PET scan
12-month CT Aortic AngiogramDiagnostic test
CT scan to assess aortic morphology and the stent graft
24-month reviewOther
This will consist of a telephone consultation with the study participant and review of electronic clinical records
| Study group | Role | What they receive |
|---|---|---|
| Endoleak Group | Participants with a previous Endovascular Aneurysm Repair (EVAR) who have developed an endoleak Receives: Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography; Diagnostic Test: CT Aortic Angiogram | |
| No Endoleak Group | Participants with a previous Endovascular Aneurysm Repair (EVAR) who have not developed an endoleak Receives: Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography; Diagnostic Test: CT Aortic Angiogram | |
| Pre-EVAR Group | Participants who have an abdominal aortic aneurysm and who are undergoing an Endovascular Aneurysm Repair as standard of care Receives: Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography; Diagnostic Test: 12-month CT Aortic Angiogram; Other: 24-month review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (10)
Pattern of microcalcification activity in the stented aorta
Microcalcification activity
Measured: 12 months
Intensity of microcalcification activity in the stented aorta
Microcalcification activity
Measured: 12 months
Endoleaks
Computed tomography and ultrasound endpoints
Measured: 12 months
Stent graft migration
Computed tomography and ultrasound endpoints
Measured: 12 months
Aneurysm sac diameter
Computed tomography and ultrasound endpoints
Measured: 12 months
Neck diameter and neck angulation
Computed tomography and ultrasound endpoints
Measured: 12 months
Geometry: tortuosity, curvature, torsion
Computed tomography and ultrasound endpoints
Measured: 12 months
Aneurysm-related mortality
Clinical endpoints
Measured: 24 months
Re-intervention
Clinical endpoints
Measured: 24 months
All-cause mortality
Clinical endpoints
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Apr 2021
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian, NHS Greater Glasgow and Clyde, NHS Lanarkshire, NHS Tayside
- Responsible party
- Sponsor
- Investigators
- Samuel Debono, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577716
- Sponsor's protocol ID
- AC20136
- Acronym
- PET-EVAR
- Status last verified
- Jun 2025
- First submitted
- 16 Sep 2020
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There are no plans for individual participant data sharing.
Publications
Debono S, Nash J, Fletcher AJ, Syed M, van Beek EJR, Williams MC, Falah O, Tambyraja A, Dweck MR, Newby DE, Forsythe RO. Aortic sodium [18F]fluoride uptake following endovascular aneurysm repair. Heart. 2023 Oct 26;109(22):1677-1682. doi: 10.1136/heartjnl-2023-322514.
PubMed 37164479Debono S, Nash J, Tambyraja AL, Newby DE, Forsythe RO. Endovascular repair for abdominal aortic aneurysms. Heart. 2021 Nov;107(22):1783-1789. doi: 10.1136/heartjnl-2020-318288. Epub 2021 Mar 4.
PubMed 33674354
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PET-EVAR Study - Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride
- ClinicalTrials.gov ID
- NCT04577716
- Acronym / sponsor ID
- PET-EVAR / AC20136
- Conditions
- Abdominal Aortic Aneurysm, Endoleak, Stent-Graft Endoleak
- Keywords
- EVAR, Endoleak, 18F-Sodium Fluoride, PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian, NHS Greater Glasgow and Clyde, NHS Lanarkshire, NHS Tayside
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endoleak Group | – | Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, Diagnostic Test: CT Aortic AngiogramParticipants with a previous Endovascular Aneurysm Repair (EVAR) who have developed an endoleak |
| No Endoleak Group | – | Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, Diagnostic Test: CT Aortic AngiogramParticipants with a previous Endovascular Aneurysm Repair (EVAR) who have not developed an endoleak |
| Pre-EVAR Group | – | Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, Diagnostic Test: 12-month CT Aortic Angiogram, Other: 24-month reviewParticipants who have an abdominal aortic aneurysm and who are undergoing an Endovascular Aneurysm Repair as standard of care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F Sodium Fluoride Positron Emission Tomography / Computed TomographyPET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan | Diagnostic test | Endoleak Group, No Endoleak Group, Pre-EVAR Group |
| CT Aortic AngiogramCT scan to assess aortic morphology and contextualise PET scan | Diagnostic test | Endoleak Group, No Endoleak Group |
| 12-month CT Aortic AngiogramCT scan to assess aortic morphology and the stent graft | Diagnostic test | Pre-EVAR Group |
| 24-month reviewThis will consist of a telephone consultation with the study participant and review of electronic clinical records | Other | Pre-EVAR Group |
Primary outcome
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.
10 secondary outcomes
Pattern of microcalcification activity in the stented aorta
Time frame: 12 months
Intensity of microcalcification activity in the stented aorta
Time frame: 12 months
Endoleaks
Time frame: 12 months
Stent graft migration
Time frame: 12 months
Aneurysm sac diameter
Time frame: 12 months
Neck diameter and neck angulation
Time frame: 12 months
Geometry: tortuosity, curvature, torsion
Time frame: 12 months
Aneurysm-related mortality
Time frame: 24 months
Re-intervention
Time frame: 24 months
All-cause mortality
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 37164479Debono S, Nash J, Fletcher AJ, Syed M, van Beek EJR, Williams MC, Falah O, Tambyraja A, Dweck MR, Newby DE, Forsythe RO. Aortic sodium [18F]fluoride uptake following endovascular aneurysm repair. Heart. 2023 Oct 26;109(22):1677-1682. doi: 10.1136/heartjnl-2023-322514.
- Derived from this study: PubMed 33674354Debono S, Nash J, Tambyraja AL, Newby DE, Forsythe RO. Endovascular repair for abdominal aortic aneurysms. Heart. 2021 Nov;107(22):1783-1789. doi: 10.1136/heartjnl-2020-318288. Epub 2021 Mar 4.
- Individual participant dataSharing planned: No. There are no plans for individual participant data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Debono principal investigator
University of Edinburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Endoleak, run by University of Edinburgh at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microcalcification activity in stented and aneurysmal aorta (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04577716, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.