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RecruitingNCT05777447MAAIUpdated Mar 18, 2025

International Multicenter Mycotic Aneurysm Aorto-iliac Study

An observational study in Mycotic Aneurysm and Aortic Diseases, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2020; still recruiting 6 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

The term mycotic aneurysm (MA) is commonly used to describe all infected aneurysms. Although MAs are believed to occur uncommonly, the true incidence is difficult to determine and is probably underestimated since MAs can be asymptomatic and are diagnosed only at autopsy. In an autoptic study, mycotic aortic aneurysms (MAAs) were reported in 3.3% of all detected aneurysms. The incidence of infected aneurysms of the aorta and iliac arteries ranges from 0.6% to 1.3%.

A recent literature review of the management of MAAs showed that therapeutic strategies are multiple, including open surgical repair (OSR) in the majority of cases, endovascular aortic repair (EVAR), which increased over the last decade, and medical treatment alone for patients unfit for any aortic repair in a very limited part. Following the unfavorable prognosis towards rupture and since the medical treatment alone in mycotic aneurysms has shown mortality of almost 100%, surgical treatment is generally the preferred option.

Surgical treatment includes both open and endovascular surgery. The latter is less invasive than conventional surgery but does not involve resection of the infected tissue and is therefore associated with an increased risk of sepsis and prosthesis infection. The gold standard is still open surgery, including extra-anatomic reconstruction and in situ repair, with different type of vascular graft.

This is a multicenter retrospective observational study. It will examine all patients undergoing surgical treatment of mycotic aortic-iliac aneurysms and in situ reconstruction at the participating centers.

02

Conditions studied

  • Mycotic Aneurysm
  • Aortic Diseases

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03

In context

Aortic Diseases

108 studies on the registry are indexed under Aortic Diseases; 43 are open to participants now.

This study's planned enrollment of 40 is below the median of 186 across 62 observational studies indexed under Aortic Diseases.

Browse Aortic Diseases studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients undergoing surgical treatment of mycotic aortic-iliac aneurysms and in situ reconstruction at the participating centers.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • primary mycotic aorto-iliac aneurysm who underwent in situ repair

Exclusion criteria

Exclusion Criteria:

  • patient with vascular graft infections;
  • patient with secondary aorto-enteric fistula.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • ProcedureMycotic aortic-iliac aneurysms and in situ reconstruction

    Surgical treatment of mycotic aortic-iliac aneurysms and in situ reconstruction

06

What researchers measure

Primary outcomes

  1. Early mortality

    Mortality after surgery

    Time frame: Mortality within 30 days after surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05777447
Responsible party
TINELLI GIOVANNI (Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Mar 21, 2023
Start date
Jan 1, 2020
Primary completion
Jan 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Mar 18, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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