Statistical analysis plan for the ARtificially Intelligent image fusion system versus standard treatment to guide endovascular Aortic aneurysm repair (ARIA): a multi-centre randomised controlled trial.

Hatem A Wafa^1,2, James Budge^3,4, Tom Carrell⁵, Medeah Yaqub⁶, Matt Waltham⁵, Izabela Pilecka⁶, Joanna Kelly⁶, Caroline Murphy⁶, Stephen Palmer⁷, Rachel E Clough³, Yanzhong Wang⁸

¹School of Biomedical Engineering and Imaging Science, King's College London, London, UK. hatem.a.wafa@kcl.ac.uk.

²School of Life Course & Population Health Sciences, Faculty of Life Sciences & Medicine, King's College London, 5th floor, Addison House, Guy's Campus, London, SE1 1UL, UK. hatem.a.wafa@kcl.ac.uk.

³School of Biomedical Engineering and Imaging Science, King's College London, London, UK.

⁴St George's Vascular Institute, St George's University, London, UK.

⁵Cydar Medical Limited, Cambridge, UK.

⁶King's Clinical Trial Unit, King's College London, London, UK.

⁷Centre for Health Economics, University of York, York, UK.

⁸School of Life Course and Population Sciences, King's College London, London, UK.

PubMed PMC DOI PDF

Abstract

BACKGROUND: Aortic aneurysms, a significant cause of mortality, particularly in individuals aged 55 years and older, have witnessed a transformative shift in treatment strategies with the advent of endovascular surgery. Cydar-EV is an innovative image fusion technology that can augment preoperative planning and surgical guidance of endovascular aneurysm repair (EVAR). The ARIA trial aims to evalua…

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Mentioned Companies

Cydar
affiliation

MeSH Terms

Humans0Endovascular Procedures*Aortic Aneurysm, Abdominal*Multicenter Studies as Topic0Treatment Outcome0Surgery, Computer-Assisted*Aortic Aneurysm, Thoracic*Blood Vessel Prosthesis Implantation*Randomized Controlled Trials as Topic0Cost-Benefit Analysis0Clinical Trials, Phase III as Topic0Time Factors0Operative Time0Male0Aged0Middle Aged0Data Interpretation, Statistical0Female0

Article Info

PMID: 40307841
PMCID: PMC12042510
DOI: 10.1186/s13063-025-08770-5
Received: June 27, 2024
Accepted: February 10, 2025

How to Cite

Wafa HA et al. Statistical analysis plan for the ARtificially Intelligent image fusion system versus standard treatment to guide endovascular Aortic aneurysm repair (ARIA): a multi-centre randomised controlled trial. Trials2025;26(1):143. doi:10.1186/s13063-025-08770-5

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