Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride
- Conditions
- Stent-Graft EndoleakAbdominal Aortic AneurysmEndoleak
- Interventions
- Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed TomographyDiagnostic Test: CT Aortic AngiogramDiagnostic Test: 12-month CT Aortic AngiogramOther: 24-month review
- Registration Number
- NCT04577716
- Lead Sponsor
- University of Edinburgh
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 102
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No Endoleak Group 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography Participants with a previous Endovascular Aneurysm Repair (EVAR) who have not developed an endoleak Endoleak Group 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography Participants with a previous Endovascular Aneurysm Repair (EVAR) who have developed an endoleak No Endoleak Group CT Aortic Angiogram Participants with a previous Endovascular Aneurysm Repair (EVAR) who have not developed an endoleak Endoleak Group CT Aortic Angiogram Participants with a previous Endovascular Aneurysm Repair (EVAR) who have developed an endoleak Pre-EVAR Group 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography Participants who have an abdominal aortic aneurysm and who are undergoing an Endovascular Aneurysm Repair as standard of care Pre-EVAR Group 12-month CT Aortic Angiogram Participants who have an abdominal aortic aneurysm and who are undergoing an Endovascular Aneurysm Repair as standard of care Pre-EVAR Group 24-month review Participants who have an abdominal aortic aneurysm and who are undergoing an Endovascular Aneurysm Repair as standard of care
- Primary Outcome Measures
Name Time Method Microcalcification activity in stented and aneurysmal aorta 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 Outcome Measures
Name Time Method Pattern of microcalcification activity in the stented aorta 12 months Microcalcification activity
Intensity of microcalcification activity in the stented aorta 12 months Microcalcification activity
Endoleaks 12 months Computed tomography and ultrasound endpoints
Stent graft migration 12 months Computed tomography and ultrasound endpoints
Aneurysm sac diameter 12 months Computed tomography and ultrasound endpoints
Aneurysm-related mortality 24 months Clinical endpoints
Neck diameter and neck angulation 12 months Computed tomography and ultrasound endpoints
Geometry: tortuosity, curvature, torsion 12 months Computed tomography and ultrasound endpoints
Re-intervention 24 months Clinical endpoints
All-cause mortality 24 months Clinical endpoints
Trial Locations
- Locations (4)
Ninewells Hospital
🇬🇧Dundee, United Kingdom
University Hospital Hairmyres
🇬🇧East Kilbride, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom