The ARIA trial protocol: a randomised controlled trial to assess the clinical, technical, and cost-effectiveness of a cloud-based, ARtificially Intelligent image fusion system in comparison to standard treatment to guide endovascular Aortic aneurysm repair.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Aortic Aneurysm, Abdominal*/diagnostic imaging ; Aortic Aneurysm, Abdominal*/surgery ; Endovascular Procedures*/methods ; Blood Vessel Prosthesis Implantation*/adverse effects; Humans ; Cost-Benefit Analysis ; Cloud Computing ; Treatment Outcome ; Retrospective Studies ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic

Background: Endovascular repair of aortic aneurysmal disease is established due to perceived advantages in patient survival, reduced postoperative complications, and shorter hospital lengths of stay. High spatial and contrast resolution 3D CT angiography images are used to plan the procedures and inform device selection and manufacture, but in standard care, the surgery is performed using image-guidance from 2D X-ray fluoroscopy with injection of nephrotoxic contrast material to visualise the blood vessels. This study aims to assess the benefit to patients, practitioners, and the health service of a novel image fusion medical device (Cydar EV), which allows this high-resolution 3D information to be available to operators at the time of surgery.
Methods: The trial is a multi-centre, open label, two-armed randomised controlled clinical trial of 340 patient, randomised 1:1 to either standard treatment in endovascular aneurysm repair or treatment using Cydar EV, a CE-marked medical device comprising of cloud computing, augmented intelligence, and computer vision. The primary outcome is procedural time, with secondary outcomes of procedural efficiency, technical effectiveness, patient outcomes, and cost-effectiveness. Patients with a clinical diagnosis of AAA or TAAA suitable for endovascular repair and able to provide written informed consent will be invited to participate.
Discussion: This trial is the first randomised controlled trial evaluating advanced image fusion technology in endovascular aortic surgery and is well placed to evaluate the effect of this technology on patient outcomes and cost to the NHS.
Trial Registration: ISRCTN13832085. Dec. 3, 2021.
(© 2024. The Author(s).)

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NIHR201004 Invention for Innovation Programme

Keywords: AI; Aneurysm; Aortic surgery; BEVAR; Computer vision; Cydar; EVAR; Endovascular; FEVAR; Image fusion

Date Created: 20240326 Date Completed: 20240327 Latest Revision: 20240328

20240329

PMC10962083

10.1186/s13063-023-07710-5

38528619