Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride
Key facts
- Who runs it
- University of Edinburgh
- Where
- United Kingdom4 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 102 people enrolled
- Started
- 1 Apr 2021
- Ended
- 31 Mar 2025
- Type of study
- Observational, 3 groups
- Treatments tested
- 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
- CT Aortic Angiogram
- 12-month CT Aortic Angiogram
- 24-month review
- Record updated
- 3 July 2025
Who can take part
- Age
- 50 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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 take part
- Major or untreated cancer
- Allergy or contra-indication to iodinated contrast
- Known history of connective tissue disease
- Chronic kidney disease (eGFR ≤ 30 mL/min/1.73 m2)
- The inability of patients to undergo PET/CT scanning
- Pregnancy
- Inability or unwillingness to give informed consent
- Life-expectancy of less than two years
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Endoleak Group
Participants with a previous Endovascular Aneurysm Repair (EVAR) who have developed an endoleak
Treatment: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography and CT Aortic Angiogram
- No Endoleak Group
Participants with a previous Endovascular Aneurysm Repair (EVAR) who have not developed an endoleak
Treatment: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography and 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
Treatment: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography, 12-month CT Aortic Angiogram, and 24-month review
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The PET-EVAR Study - Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride
- Record updated
- 3 July 2025