Aortic Infections and InflammationsNCT06188819
Rolled Pericardium Versus Cryopreserved Allograft to Treat Native or Prosthetic Aortic Infection
An observational study of Aortic Infections and Inflammations, run by University Paul Sabatier of Toulouse.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Infections and Inflammations
- What is being tested?
- Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 15 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients operated on for a native infection or an aortic prosthesis who had pericardium or allograft reconstruction
Who may be able to join
- 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
Who cannot join
- no
About this study
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.
- Conditions
- Aortic Infections and Inflammations
- Being tested
- Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardiumProcedure or surgery
In situ reconstruction with explantation of the infected graft or endograft and reconstruction by allograft or pericardium
| Study group | Role | What they receive |
|---|---|---|
| Cryopreserved arterial allograft | Aortic infection treated by cryopreserved arterial allograft Receives: Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium | |
| Rolled pericardium patch | Aortic infection treated by Pericardium patch rolled Receives: Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Number of patients death during post operative stay
Measured: day 30 post operative
Reintervention
Rate of reintervention during post operative stay
Measured: 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
Measured: day 30 post operative
Secondary outcomes (2)
Permeability
Rate of reintervention for occlusion of the patch or the allograft
Measured: 30 days, 6 months, 12 months, 24 months
Reinfection
Rate of reintervention for infection of the patch or the allograft
Measured: 30 days, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Jan 2010
- Primary completion2 Jan 2010
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Infections and InflammationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paul Sabatier of Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- LUCAS BATISTELLA, MD, Kheira hireche, MD, Ludovic CANAUD, MD PhD
- Responsible party
- Principal investigator, Aurélien Hostalrich, University Paul Sabatier of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188819
- Sponsor's protocol ID
- Infected Aorta
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40122311
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rolled Pericardium Versus Cryopreserved Allograft to Treat Native or Prosthetic Aortic Infection
- ClinicalTrials.gov ID
- NCT06188819
- Acronym / sponsor ID
- Infected Aorta
- Conditions
- Aortic Infections and Inflammations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Paul Sabatier of ToulouseUniversity, hospital or other
- Collaborators
- LUCAS BATISTELLA, MD, Kheira hireche, MD, Ludovic CANAUD, MD PhD
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 2 Jan 2010 (actual)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryopreserved arterial allograft | – | Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardiumAortic infection treated by cryopreserved arterial allograft |
| Rolled pericardium patch | – | Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardiumAortic infection treated by Pericardium patch rolled |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients operated on for a native infection or an aortic prosthesis who had pericardium or allograft reconstruction
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardiumIn situ reconstruction with explantation of the infected graft or endograft and reconstruction by allograft or pericardium | Procedure or surgery | Cryopreserved arterial allograft, Rolled pericardium patch |
Primary outcome
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
2 secondary outcomes
Permeability
Time frame: 30 days, 6 months, 12 months, 24 months
Reinfection
Time frame: 30 days, 6 months, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 40122311Battistella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Infections and Inflammations, run by University Paul Sabatier of Toulouse.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: day 30 post operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.