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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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