ClinicalTrials.gg
RecruitingNCT05777681Updated Aug 11, 2025

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

An observational study in Aortic Diseases, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Oct 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Aortic Diseases

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03

In context

Aortic Diseases

108 studies on the registry are indexed under Aortic Diseases; 43 are open to participants now.

This study's planned enrollment of 30 is below the median of 186 across 62 observational studies indexed under Aortic Diseases.

Browse Aortic Diseases studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aortic infection
  • Mycotic Aneurysm
  • Aortic Graft Infection

Exclusion criteria

Exclusion Criteria:

  • Absence of signs of infection
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • ProcedureAortic Surgery

    open surgical repair with resection of infected aortic segment, debridement of surrounding tissue and in situ graft replacement.

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What researchers measure

Primary outcomes

  1. Early Mortality

    Mortality 30 days after the procedure

    Time frame: 30 days

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05777681
Responsible party
Tshomba Yamume (Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Mar 21, 2023
Start date
Oct 1, 2022
Primary completion
Nov 1, 2025 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Aug 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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