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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05399706
Other study ID # 292985
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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