Reintervention Rates and Complications in Endovascular Aneurysm Repair (EVAR) and the Use of Colour Doppler Ultrasound (CDUS) and Computed Tomography Angiography (CTA) in Identifying Endoleak Complications

May 5, 2026 updated by: Fiona Leahy, University Hospital of Limerick

To provide a robust view of EVAR surveillance at UHL, this study proposes to retrospectively assess the surveillance programme to get a better view of post-operative complications following endovascular aneurysm repair.

It will seek to identify complications that required reintervention, establish reintervention rates, and attempt to compare which imaging modalities provide the best data on post-EVAR complications.

Study Overview

Status

Completed

Conditions

Detailed Description

From 2006 to 2024, the UHL EVAR programme collected scan information on patients following endovascular repair of abdominal aortic aneurysms (AAA) and iliac aneurysms. Prior to 2015, surveillance of EVAR patients was organized by referral only. Since January 2015, structured surveillance with CDUS and CTA was performed less than 6 weeks postoperatively and then continued with automatically scheduled US scans every 6 months. Surveillance with CDUS (performed by a vascular physiologist) and CTA (interpreted by a consultant radiologist). Data on individual surveillance and complications has been collected and is available for analysis.

Study Type

Observational

Enrollment (Actual)

405

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Munster
      • Limerick, Munster, Ireland, V94 F558
        • University Hospital Limerick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will utilize an existing dataset at UHL which contains surveillance & follow-up information for patients who underwent EVAR procedures for AAA or iliac aneurysms between March 2006 and December 2024.

Description

Inclusion Criteria:

Included in registry of patients under surveillance with UHL Department of Vascular Surgery

Under surveillance from March 2006 - December 2024

Underwent EVAR for AAA or iliac aneurysm repair

Surveillance performed with both CDUS and CTA with reports available

Exclusion Criteria:

Not in registry for EVAR surveillance

Not under surveillance during study period

Underwent open repair for AAA or iliac aneurysm

Both CDUS and CTA not available

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients who have had an endovascular aneurysm repair and are under surveillance
Examine the follow up for this cohort and identify complications that required reintervention, establish reintervention rates, and attempt to compare which imaging modalities provide the best data on post-EVAR complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the type of complications detected by post-EVAR surveillance
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Limerick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Actual)

March 1, 2026

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0345
  • REC Ref 0345 (Other Identifier: HSE University Hospital Limerick)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We have presented our findings at one conference to date and have applied for a second. We will select a suitable journal and aim to get an article publication also.

IPD Sharing Time Frame

From March 2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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