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Clinical Trials/ISRCTN13832085
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)

King's College London0 sites364 target enrollmentDecember 3, 2021

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)

Registry
who.int
Start Date
December 3, 2021
End Date
November 15, 2025
Last Updated
last year
Study Type
Interventional
Sex
All

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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