Brief Title
Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride
Official Title
The PET-EVAR Study - Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride
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.
Study Type
Observational
Primary Outcome
Microcalcification activity in stented and aneurysmal aorta
Secondary Outcome
Pattern of microcalcification activity in the stented aorta
Condition
Abdominal Aortic Aneurysm
Intervention
18F Sodium Fluoride Positron Emission Tomography / Computed Tomography
Study Arms / Comparison Groups
Endoleak Group
Description: Participants with a previous Endovascular Aneurysm Repair (EVAR) who have developed an endoleak
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
144
Start Date
April 1, 2021
Completion Date
April 1, 2023
Primary Completion Date
April 1, 2023
Eligibility Criteria
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
Gender
All
Ages
50 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Samuel Debono, 01312426515, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT04577716
Organization ID
AC20136
Responsible Party
Sponsor
Study Sponsor
University of Edinburgh
Collaborators
NHS Lothian
Study Sponsor
Samuel Debono, Principal Investigator, University of Edinburgh
Verification Date
May 2022