International Multicenter Mycotic Aneurysm Aorto-iliac Study

Aortic Diseases Clinical Trial

— MAAI  

Official title:

Long Term Results of Aorto-iliac Mycotic Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05777447
• Other study ID #: 2855
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Diseases

Intervention

Procedure:
• Mycotic aortic-iliac aneurysms and in situ reconstruction
Surgical treatment of mycotic aortic-iliac aneurysms and in situ reconstruction

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early mortality	Mortality after surgery	Mortality within 30 days after surgery