ISRCTN13832085
Active, not recruiting
Phase 3
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 (ARIA)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Abdominal aortic aneurysm
- Sponsor
- King's College London
- Enrollment
- 364
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38528619/ (added 26/03/2024)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current participant inclusion criteria as of 24/01/2022:
- •1\. Clinical diagnosis of abdominal aortic aneurysm (AAA) or thoracoabdominal aortic aneurysm (TAAA) suitable for endovascular treatment, as determined by CT imaging and multidisciplinary review by treating team
- •2\. Fit for endovascular repair as determined by the operating team
- •3\. CT imaging must be in accordance with ‘Cydar EV: Instructions for Use’ i.e. scans should have the same slice thickness and intervals as the original scan acquisition, must not have any missing slices or discontinuities, must include the pelvis and whole vertebrae including the spinous processes and must not use gantry tilt (this will be done post\-consent)
- •4\. Written informed consent (patients lacking capacity or unable to speak English will not be enrolled)
- •5\. Age 18 years and above at the time of consent
- •Previous participant inclusion criteria:
- •1\. Clinical diagnosis of abdominal aortic aneurysm (AAA) or thoracoabdominal aortic aneurysm (TAAA) suitable for endovascular treatment, as determined by CT imaging and multidisciplinary review by treating team
- •2\. Fit for endovascular repair as determined by the operating team
- •3\. CT imaging must be in accordance with ‘Cydar EV: Instructions for Use’ i.e. scans should have the same slice thickness and intervals as the original scan acquisition, must not have any missing slices or discontinuities, must include the pelvis and whole vertebrae including the spinous processes and must not use gantry tilt (this will be done post\-consent)
Exclusion Criteria
- •Current participant exclusion criteria as of 24/01/2022:
- •Patients unable to provide written informed consent
- •Previous participant exclusion criteria:
- •Patients with known connective tissue disease
Outcomes
Primary Outcomes
Not specified
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