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
Abstract 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 procedure...
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| Format: | Article |
| Language: | English |
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BMC
2024-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07710-5 |
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| author | James Budge Tom Carrell Medeah Yaqub Hatem Wafa Matt Waltham Izabela Pilecka Joanna Kelly Caroline Murphy Stephen Palmer Yanzhong Wang Rachel E Clough |
| author_facet | James Budge Tom Carrell Medeah Yaqub Hatem Wafa Matt Waltham Izabela Pilecka Joanna Kelly Caroline Murphy Stephen Palmer Yanzhong Wang Rachel E Clough |
| author_sort | James Budge |
| collection | DOAJ |
| description | Abstract 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 |
| first_indexed | 2024-04-24T16:12:51Z |
| format | Article |
| id | doaj.art-1026bdf1bb8547d48be9d761c072bc9a |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-24T16:12:51Z |
| publishDate | 2024-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-1026bdf1bb8547d48be9d761c072bc9a2024-03-31T11:34:20ZengBMCTrials1745-62152024-03-0125111410.1186/s13063-023-07710-5The 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 repairJames Budge0Tom Carrell1Medeah Yaqub2Hatem Wafa3Matt Waltham4Izabela Pilecka5Joanna Kelly6Caroline Murphy7Stephen Palmer8Yanzhong Wang9Rachel E Clough10School of Biomedical Engineering & Imaging Sciences, King’s College LondonCydar Medical LimitedKing’s Clinical Trials Unit, King’s College LondonDepartment of Population Health Sciences, King’s College LondonCydar Medical LimitedKing’s Clinical Trials Unit, King’s College LondonKing’s Clinical Trials Unit, King’s College LondonKing’s Clinical Trials Unit, King’s College LondonCentre for Health Economics, University of YorkDepartment of Population Health Sciences, King’s College LondonSchool of Biomedical Engineering & Imaging Sciences, King’s College LondonAbstract 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, 2021https://doi.org/10.1186/s13063-023-07710-5EVARFEVARBEVAREndovascularAneurysmImage fusion |
| spellingShingle | James Budge Tom Carrell Medeah Yaqub Hatem Wafa Matt Waltham Izabela Pilecka Joanna Kelly Caroline Murphy Stephen Palmer Yanzhong Wang Rachel E Clough 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 Trials EVAR FEVAR BEVAR Endovascular Aneurysm Image fusion |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | EVAR FEVAR BEVAR Endovascular Aneurysm Image fusion |
| url | https://doi.org/10.1186/s13063-023-07710-5 |
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