Management of Aorto-iliac Infection With BioIntegral Surg... | NCT05777681

Studies
Management of Aorto-iliac Infection With BioIntegral Surgical No-React® Bovine Pericardial Xenografts

NCT05777681

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Recruiting

Last Update Posted

Aug 11, 2025Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Aortic Diseases

Interventions

Aortic Surgery

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Nov 1, 2025Estimated

Completion Date

Nov 1, 2026Estimated

First Submitted Date

Mar 9, 2023

First Submission Date that Met QC Criteria

Mar 9, 2023

First Posted Date

Mar 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2025

Last Update Posted Date

Aug 11, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tshomba Yamume, Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Aortic infections (AIs), including aortic graft infections (AGI) as well as mycotic aortic aneurysms (MAA), are rare. The aim of this study is to present our experience with xenogeneic aortic and aortoiliac reconstructions using the BioIntegral Surgical No-React® bovine pericardial graft.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aortic Surgery	Procedure	open surgical repair with resection of infected aortic segment, debridement of surrounding tissue and in situ graft replacement.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early Mortality	Mortality 30 days after the procedure	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aortic infection
Mycotic Aneurysm
Aortic Graft Infection

Exclusion Criteria:

Absence of signs of infection

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All consecutive patients who underwent replacement of an infected aneurysm or graft with a BioIntegral Surgical No-React® bovine pericardial prosthesis at our Institution.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario A Gemelli IRCCS	Recruiting	Rome			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001018	Aortic Diseases

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided