Sponsor study identifier
observational
150
0 countries
N/A
Study Start
January 1, 2010
Actual (reported)Primary Completion
January 2, 2010
Actual (reported)Study Completion
June 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
While surgery with anatomic reconstruction of prosthetic aortic infections and native infectious aortitis has become established over time, the ideal substitute is not clearly defined. The cryopreserved arterial allograft (AAC) recognized as resistant to infections not only presents availability problems making its use complicated, particularly in emergencies, with a certain number of long-term aneurysmal developments. The tubulized pericardium patch (PP), available in all cases, seems to give promising results in recent literature. The investigators propose a comparative study of these two substitutes in this indication. We carried out a two-center observational study including retrospectively from January 2010 to July 2023 all patients operated on for aortic prosthesis infection and native infectious aortitis with AAC reconstruction and prospectively PP patch reconstructions from July 2018 to July 2023. The diagnosis of infection was established according to the MAGIC criteria. The patients' preoperative comorbidities were collected to compare the groups. Postoperative morbidity and mortality was then compared. The medium-term evaluation consisted of comparing according to the Kaplan Meier method: postoperative mortality, permeability, reinfection rate, reoperation rate.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2010
Actual (reported)January 2, 2010
Actual (reported)December 18, 2023
Actual (reported)January 3, 2024
Actual (reported)June 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mortality
Number of patients death during post operative stay
day 30 post operative
Reintervention
Rate of reintervention during post operative stay
30 days, 6 months, 12 months, 24 months
Post operative Major cardiovascular adverse events (MACE)
Rate of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
day 30 post operative
Permeability
30 days, 6 months, 12 months, 24 months
Reinfection
30 days, 6 months, 12 months, 24 months
Aortic infection treated by cryopreserved arterial allograft
Aortic infection treated by Pericardium patch rolled
In situ reconstruction with explantation of the infected graft or endograft and reconstruction by allograft or pericardium
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
patients operated on for a native infection or an aortic prosthesis who had pericardium or allograft reconstruction
Battistella L, Kireche R, Ricco JB, Boisroux T, Shourick J, Chaufour X, Canaud L, Hostalrich A. Outcomes of native or graft abdominal aortic infection managed with orthotopic xeno pericardial grafts or cryopreserved allograft. J Vasc Surg. 2025 Jul;82(1):90-101.e3. doi: 10.1016/j.jvs.2025.03.182. Epub 2025 Mar 22.
150 participants (actual enrollment reported by the registry).
First Submitted
December 18, 2023
First Posted
January 3, 2024
Study Start
January 1, 2010
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
January 2, 2010
Actual (reported)Study Completion
June 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 10, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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