NCT05777447

Recruiting

International Multicenter Mycotic Aneurysm Aorto-iliac Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source

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Other study identifiers

Sponsor study identifier

2855

Study Type

observational

Estimated enrollment

40

Locations

1 country

Sites

1

Timeline

Study Start

January 1, 2020

Actual (reported)

Primary Completion

January 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

January 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 40 participants
Study completion date: January 1, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 1, 2020
Actual (reported)
First Submitted
March 9, 2023
Actual (reported)
First Posted
March 21, 2023
Actual (reported)
Primary Completion
January 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: March 18, 2025
Status Verified: March 2025
Last Update Submitted: March 15, 2025

Conditions

Aortic Diseases Mycotic Aneurysm

Outcome Measures

Primary Outcomes (1)

Early mortality
Mortality after surgery
Mortality within 30 days after surgery

Interventions

Mycotic aortic-iliac aneurysms and in situ reconstructionProcedure

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

primary mycotic aorto-iliac aneurysm who underwent in situ repair

You may not qualify if:

Sponsors & Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Otherlead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00167, Italy

RECRUITING

Giovanni TinelliCONTACT0039 0630157205 giovanni.tinelli@policlinicogemelli.it

MeSH Terms

Conditions

Aneurysm, InfectedAortic Diseases

Condition Hierarchy (Ancestors)

InfectionsAneurysmVascular DiseasesCardiovascular Diseases

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Prof

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 21, 2023

Study Start

January 1, 2020

Actual (reported)

Primary Completion

January 1, 2026

Estimated (date passed)

Ultrasound-Guided Resuscitation in Open Aortic Surgery

Not ApplicableUnknown

NCT03665558

Effect of Pacing on Aortic dP/dt Values

Not ApplicableCompleted

NCT03824626

Biomechanical Reappraisal of Planning for Thoracic Endovascular Aortic Repair

Unknown

NCT05872282

Percutaneous Endovascular Arch Repair Trial (PEART) Study

Not ApplicableUnknown

NCT07117825

Aortic Dissection fAlse enlarGement radIomics predictiOn

Active Not Recruiting

NCT02524834

Endovascular Repair of Descending ThoracoAbdominal Aortic Pathologies Using Physician Modified Endovascular Prosthesis

Not ApplicableWithdrawn

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

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

January 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05777447
Data provider: ClinicalTrials.gov
Source updated: 2025-03-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:14 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Data Sharing

Source record

Locations