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NCT05777681 Clinical Trial

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

Aortic Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05777681
Other study ID # 5142
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date November 1, 2026

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

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date November 1, 2026
Est. primary completion date November 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aortic infection - Mycotic Aneurysm - Aortic Graft Infection Exclusion Criteria: - Absence of signs of infection

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Aortic Surgery
open surgical repair with resection of infected aortic segment, debridement of surrounding tissue and in situ graft replacement.

Locations
Country Name City State
Italy Fondazione Policlinico Universitario A Gemelli IRCCS Rome

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 30 days after the procedure 30 days
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