MAAI: International Multicenter Mycotic Aneurysm Aorto-iliac Study

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05777447
Collaborator
(none)
40
1
48
0.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Mycotic aortic-iliac aneurysms and in situ reconstruction

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Long Term Results of Aorto-iliac Mycotic Aneurysms
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Early mortality [Mortality within 30 days after surgery]

    Mortality after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • primary mycotic aorto-iliac aneurysm who underwent in situ repair
Exclusion Criteria:
  • patient with vascular graft infections;

  • patient with secondary aorto-enteric fistula.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione Policlinico Universitario A. Gemelli IRCCS Roma RM Italy 00167

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TINELLI GIOVANNI, Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05777447
Other Study ID Numbers:
  • 2855
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2023