Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride (NCT04577716) | Clinical Trial Compass
CompletedNot Applicable
Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride
United Kingdom102 participantsStarted 2021-04-01
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Microcalcification activity in stented and aneurysmal aorta