跳至主要内容
临床试验/ISRCTN13832085
ISRCTN13832085进行中(未招募)3 期

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 个研究点目标入组 364 人开始时间: 2021年12月3日最近更新:
适应症

试验速览

阶段
3 期
状态
进行中(未招募)
入组人数
364

研究概览

简要总结

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

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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

研究者

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