Aneurysm AbdominalNCT07581392
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
An observational study of Aneurysm Abdominal, run by University Hospital of Limerick at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Aneurysm Abdominal
- How many people
- 405 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jan 2026to 1 Mar 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Aneurysm Abdominal
- Keywords
- Endovascular Aneurysm Repair
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the type of complications detected by post-EVAR surveillance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jan 2026
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 405 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona Leahy, University Hospital of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581392
- Sponsor's protocol ID
- 0345
- Other IDs
- REC Ref 0345
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07581392
- Acronym / sponsor ID
- 0345
- Conditions
- Aneurysm Abdominal
- Keywords
- Endovascular Aneurysm Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- University Hospital of LimerickUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the type of complications detected by post-EVAR surveillance
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Aneurysm Abdominal
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm Abdominal, run by University Hospital of Limerick at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the type of complications detected by post-EVAR surveillance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.