---
title: Rolled Pericardium Versus Cryopreserved Allograft to Treat Native or Prosthetic Aortic Infection
nct_id: NCT06188819
overall_status: UNKNOWN
sponsor: University Paul Sabatier of Toulouse
study_type: OBSERVATIONAL
primary_condition: Aortic Infections and Inflammations
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06188819.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06188819"
ct_last_update_post_date: 2024-01-10
last_seen_at: "2026-05-12T07:17:21.815Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Rolled Pericardium Versus Cryopreserved Allograft to Treat Native or Prosthetic Aortic Infection

**NCT ID:** [NCT06188819](https://clinicaltrials.gov/study/NCT06188819)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 150
- **Lead Sponsor:** University Paul Sabatier of Toulouse
- **Collaborators:** LUCAS BATISTELLA, MD, Kheira hireche, MD, Ludovic CANAUD, MD PhD
- **Conditions:** Aortic Infections and Inflammations
- **Start Date:** 2010-01-01
- **Completion Date:** 2024-06-15
- **CT.gov Last Update:** 2024-01-10

## Brief Summary

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.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* All aortic intervention performed for native aortic infection reconstruction with patch or allograft
* All aortic intervention performed for infected graft reconstruction with patch or allograft

Exclusion Criteria:

* no
```

## Arms

- **Cryopreserved arterial allograft** — Aortic infection treated by cryopreserved arterial allograft
- **Rolled pericardium patch** — Aortic infection treated by Pericardium patch rolled

## Interventions

- **Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium** (PROCEDURE) — In situ reconstruction with explantation of the infected graft or endograft and reconstruction by allograft or pericardium

## Primary Outcomes

- **Mortality** _(time frame: day 30 post operative)_ — Number of patients death during post operative stay
- **Reintervention** _(time frame: 30 days, 6 months, 12 months, 24 months)_ — Rate of reintervention during post operative stay
- **Post operative Major cardiovascular adverse events (MACE)** _(time frame: day 30 post operative)_ — Rate of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

## Secondary Outcomes

- **Permeability** _(time frame: 30 days, 6 months, 12 months, 24 months)_
- **Reinfection** _(time frame: 30 days, 6 months, 12 months, 24 months)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06188819.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06188819*  
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