Comparing x-ray to artificial intelligence guidance in keyhole aortic aneurysm surgery

Phase 3

• Conditions: Abdominal aortic aneurysm; Circulatory System; Abdominal aortic aneurysm, without mention of rupture

• Registration Number: ISRCTN13832085
• Lead Sponsor: King's College London

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38528619/ (added 26/03/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-03
• Last Update Posted: 22 July 2024
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 364

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)
4. Written informed consent (patients lacking capacity will not be enrolled)
5. Age 18 years and above at the time of 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified