Sex-specific Differences in AAA Complexity

AAA - Abdominal Aortic Aneurysm Clinical Trial

Official title:

Retrospective Cohort Analysis of Sex-specific Differences in Abdominal Aortic Aneurysm Complexity and Association With Adverse Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05399706
• Other study ID #: 292985
• Status: Not yet recruiting
• Start date: July 31, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: June 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective cohort study of computed tomography scans of AAA patients considered for repair, in order to identify sex specific differences in abdominal aortic aneurysm (AAA) metrics and the association between anatomical differences/features of complexity and adverse patient outcome.

Description:

A retrospective cohort study of computed tomography scans of AAA patients considered for repair. The study aims to, firstly, identify sex specific differences in abdominal aortic aneurysm (AAA) metrics utilising manual and automated image processing techniques; and secondly, if numbers are sufficient, explore the association between features of AAA complexity and adverse patient outcome.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• All adult patients with AAA receiving assessment +/- primary open or endovascular repair at participating centre from 1/1/2010 to 31/12/2020.
• Must have AAA >= 5cm.
• Must have CT imaging within 1 year of operation or definitive turn down for treatment.

Exclusion Criteria:

• Insufficient CT imaging quality (>3mm slices) or lack of CT within 1 year of operation.
• Insufficient clinical data to establish risk factors or clinical outcomes.
• Ruptured aneurysm, aorto-iliac occlusive disease, isolated iliac aneurysm, penetrating aortic ulcer, dissection, juxta or supra-renal aneurysm.
• Secondary repair/not primary treatment decision for AAA repair.

Related Conditions & MeSH terms

• AAA - Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Diagnostic Test:
• CTA Aorta
Computed Tomography Angiography - Aorta Whole

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sex-specific differences in thrombus burden	Volumetric assessment of aortic thrombus	Pre-operative CT
Primary	Sex-specific differences in anatomical complexity	Anatomical as assessed by current IFU (instructions for use) criteria. (Anatomy within pre-specified vessel diameter, length, tortuosity and calcification criteria for insertion of endovascular stent graft for AAA repair.)	Pre-operative CT
Secondary	Association between anatomical differences and adverse patient outcome for patients receiving operative repair - need for transfusion, risk of vessel injury, ischaemia (bowel or limb), renal injury and re-intervention/endoleak.	Post-operative outcomes	30 days