International Multicenter Mycotic Aneurysm Aorto-iliac Study

NCT ID: NCT05777447

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2027-01-01

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.

Conditions

Mycotic Aneurysm; Aortic Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Mycotic aortic-iliac aneurysms and in situ reconstruction

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

TINELLI GIOVANNI

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giovanni Tinelli

Role: primary

giovanni.tinelli@policlinicogemelli.it

0039 0630157205

Other Identifiers

2855

Identifier Type: -

Identifier Source: org_study_id