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Sex-specific Differences in AAA Complexity

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05399706
Enrollment
1000
Registered
2022-06-01
Start date
2022-07-31
Completion date
2024-10-01
Last updated
2022-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AAA - Abdominal Aortic Aneurysm

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTCTA Aorta

Computed Tomography Angiography - Aorta Whole

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sex-specific differences in thrombus burdenPre-operative CTVolumetric assessment of aortic thrombus
Sex-specific differences in anatomical complexityPre-operative CTAnatomical 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.)

Secondary

MeasureTime frameDescription
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.30 daysPost-operative outcomes

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026