Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride (PET-EVAR)

University of Edinburgh

Status: Completed

Conditions: Endoleak; Stent-Graft Endoleak; Abdominal Aortic Aneurysm

Treatments: Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography; Other: 24-month review; Diagnostic Test: 12-month CT Aortic Angiogram; Diagnostic Test: CT Aortic Angiogram

Study type: Observational

Funder types: Other

Identifiers

NCT04577716

AC20136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

102 participants in 3 patient groups

Endoleak Group

Description:

Participants with a previous Endovascular Aneurysm Repair (EVAR) who have developed an endoleak

Treatment:

Diagnostic Test: CT Aortic Angiogram

Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography

No Endoleak Group

Description:

Participants with a previous Endovascular Aneurysm Repair (EVAR) who have not developed an endoleak

Treatment:

Diagnostic Test: CT Aortic Angiogram

Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography

Pre-EVAR Group

Description:

Participants who have an abdominal aortic aneurysm and who are undergoing an Endovascular Aneurysm Repair as standard of care

Treatment:

Diagnostic Test: 12-month CT Aortic Angiogram

Other: 24-month review

Diagnostic Test: 18F Sodium Fluoride Positron Emission Tomography / Computed Tomography