Sex-specific Differences in AAA Complexity

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Sex-specific Differences in AAA Complexity

Official Title

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

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.

Study Type

Observational

Primary Outcome

Sex-specific differences in thrombus burden

Secondary Outcome

 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.

Condition

AAA - Abdominal Aortic Aneurysm

Intervention

CTA Aorta

Study Arms / Comparison Groups

 Men
Description:  Male participants

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

1000

Start Date

July 31, 2022

Completion Date

October 1, 2024

Primary Completion Date

October 1, 2024

Eligibility Criteria

        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.

Gender

All

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT05399706

Organization ID

292985

Responsible Party

Sponsor

Study Sponsor

Imperial College London

Study Sponsor

, ,

Verification Date

June 2022