Ignite Creation Date:
2024-05-06 @ 2:30 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04333641
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2020-03-31
Brief Title:
Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n323
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 04 cm per year at 1 year
Secondary endpoints 1 clinical events death aortic rupture aneurysm growth 04 cm per year surgical or endovascular repair 2 Changes in CT parameters of aneurysm diameter volume wall shear stress
Study design a multicenter single-arm prospective observational study
Subject patients with small abdominal aortic aneurysm with maximal diameter of 30-50 mm n323
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 04 cm per year at 1 year
Secondary endpoints 1 clinical events death aortic rupture aneurysm growth 04 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None