NCT04333641

Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 323 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Study purpose: This study will investigate anatomical factors associated with increased risk of major adverse aorta-related event and accelerated growth of abdominal aneurysm based on 3-dimensional analysis of CT images. Study design: a multicenter single-arm prospective observational study. Subject: patients with small abdominal aortic aneurysm with maximal diameter of 30-50 mm (n=323) Methods: Patients diagnosed with small AAA based on CT will be enrolled after considering inclusion and exclusion criteria and prospectively followed clinically and with CT at 1 year. Primary endpoint: Major adverse aorta-related events (death, aortic rupture, or aneurysm growth \>0.4 cm per year) at 1 year Secondary endpoints: 1) clinical events : death, aortic rupture, aneurysm growth \>0.4 cm per year, surgical or endovascular repair 2) Changes in CT parameters of aneurysm: diameter, volume, wall shear stress

Detailed description

Prospective single-arm multicenter registry

Conditions

• Abdominal Aortic Aneurysm (AAA)

Timeline

• Start date: 2020-04-03
• Primary completion: 2023-04-17
• Completion: 2023-04-17
• First posted: 2020-04-03
• Last updated: 2024-03-26

Locations

1 site across 1 country: South Korea