Abdominal Aortic Aneurysm Clinical Trial
— PET-EVAROfficial title:
The PET-EVAR Study - Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride
Verified date | July 2023 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 102 |
Est. completion date | May 20, 2026 |
Est. primary completion date | May 20, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Ninewells Hospital | Dundee | |
United Kingdom | University Hospital Hairmyres | East Kilbride | |
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | |
United Kingdom | Queen Elizabeth University Hospital | Glasgow |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | NHS Greater Glasgow and Clyde, NHS Lanarkshire, NHS Lothian, NHS Tayside |
United Kingdom,
Debono S, Nash J, Fletcher AJ, Syed M, van Beek EJR, Williams MC, Falah O, Tambyraja A, Dweck MR, Newby DE, Forsythe RO. Aortic sodium [18F]fluoride uptake following endovascular aneurysm repair. Heart. 2023 May 10:heartjnl-2023-322514. doi: 10.1136/heart — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Co-localisation of 18F-Sodium Fluoride with histological changes in aortic tissue | Uptake of 18F-Sodium Fluoride will be identified on PET-CT scans that are acquired as part of the study visit. This will be compared with histological changes in aortic specimens obtained if participant undergoes an open aortic procedure during the study period. | 12-36 months | |
Primary | Microcalcification activity in stented and aneurysmal aorta | Will be measured as 18F Sodium Fluoride binding in the aorta. Uptake will be quantified in Standardised Uptake Values and as a tissue to background ratios. | 12 months | |
Secondary | Pattern of microcalcification activity in the stented aorta | Microcalcification activity | 12 months | |
Secondary | Intensity of microcalcification activity in the stented aorta | Microcalcification activity | 12 months | |
Secondary | Endoleaks | Computed tomography and ultrasound endpoints | 12 months | |
Secondary | Stent graft migration | Computed tomography and ultrasound endpoints | 12 months | |
Secondary | Aneurysm sac diameter | Computed tomography and ultrasound endpoints | 12 months | |
Secondary | Neck diameter and neck angulation | Computed tomography and ultrasound endpoints | 12 months | |
Secondary | Geometry: tortuosity, curvature, torsion | Computed tomography and ultrasound endpoints | 12 months | |
Secondary | Aneurysm-related mortality | Clinical endpoints | 24 months | |
Secondary | Re-intervention | Clinical endpoints | 24 months | |
Secondary | All-cause mortality | Clinical endpoints | 24 months |
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