Management of Aorto-iliac Infection With BioIntegral Surgical No-React® Bovine Pericardial Xenografts
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05777681
Collaborator
(none)
30
1
49
0.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
30 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Management of Aorto-iliac Infection With BioIntegral Surgical No-React® Bovine Pericardial Xenografts
Actual Study Start Date
:
Oct 1, 2022
Anticipated Primary Completion Date
:
Nov 1, 2023
Anticipated Study Completion Date
:
Nov 1, 2026
Outcome Measures
Primary Outcome Measures
- Early Mortality [30 days]
Mortality 30 days after the procedure
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
Aortic infection
-
Mycotic Aneurysm
-
Aortic Graft Infection
Exclusion Criteria:
- Absence of signs of infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Universitario A Gemelli IRCCS | Rome | Italy |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Tshomba Yamume,
Prof,
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05777681
Other Study ID Numbers:
- 5142
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: