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

Launched by UNIVERSITY OF EDINBURGH · Sep 30, 2020

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how well a special imaging test called Sodium Fluoride PET-CT can predict complications known as endoleaks after a procedure called Endovascular Aneurysm Repair (EVAR). An endoleak is when blood leaks out of the stent graft that is used to repair an abdominal aortic aneurysm (AAA), which can lead to further health issues. The researchers aim to see if the amount of Sodium Fluoride taken up by the body can help identify patients at risk for these complications after their surgery.

To be eligible for this study, participants must be at least 50 years old and have been diagnosed with an abdominal aortic aneurysm that requires endovascular repair. They should also be able to understand and agree to participate in the study. However, some people may not qualify if they have certain health conditions, like severe kidney problems or untreated cancer, or if they are pregnant. If you join the trial, you can expect to undergo PET-CT scans to help the researchers gather important information about your health following the repair. Overall, this study is actively looking for participants to help improve future treatments for patients with abdominal aortic aneurysms.

Gender

ALL

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
• • Life-expectancy of less than two years
• • Known history of connective tissue disease