NCT04577716

Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride

The PET-EVAR Study - Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 102 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aortic Aneurysm
• Endoleak
• Stent-Graft Endoleak

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	18F Sodium Fluoride Positron Emission Tomography / Computed Tomography	PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
DIAGNOSTIC_TEST	CT Aortic Angiogram	CT scan to assess aortic morphology and contextualise PET scan
DIAGNOSTIC_TEST	12-month CT Aortic Angiogram	CT scan to assess aortic morphology and the stent graft
OTHER	24-month review	This will consist of a telephone consultation with the study participant and review of electronic clinical records

Timeline

• Start date: 2021-04-01
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2020-10-08
• Last updated: 2025-07-03

Locations

4 sites across 1 country: United Kingdom