Sex-specific Differences in AAA Complexity
Retrospective Cohort Analysis of Sex-specific Differences in Abdominal Aortic Aneurysm Complexity and Association With Adverse Outcomes
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
July 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedJune 23, 2022
June 1, 2022
2.2 years
May 24, 2022
June 22, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Sex-specific differences in thrombus burden
Volumetric assessment of aortic thrombus
Pre-operative CT
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 Outcomes (1)
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 days
Study Arms (2)
Men
Male participants
Women
Female Participants
Interventions
Eligibility Criteria
Patients with AAA receiving assessment +/- primary open or endovascular repair.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College London
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2022
First Posted
June 1, 2022
Study Start
July 31, 2022
Primary Completion
October 1, 2024
Study Completion
October 1, 2024
Last Updated
June 23, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share