AortitisCohorte VIPNCT06866535
VIP - Vascular Infection Project
An observational study of Aortitis and Vascular Graft Infection, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Constitution of a prospective multicentric observational database to study vascular infections, both native, especially aortitis, and vascular graft and endograft infections. Clinical and paraclinical data on medical, surgical, anesthetic and intensive care management will be collected in order to better characterize… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortitis, Vascular Graft Infection, Blood Vessel Prosthesis
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2022to 10 May 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ents with a vascular infection, either native (aortitis, arteritis) or prosthetic (vascular graft, endograft and/or stent)
Who may be able to join
- ≥ 18 years-old;
- all patients with a vascular infection, either native (aortitis, arteritis) or prosthetic (vascular graft, endograft and/or stent),
- oral consent
Who cannot join
- patient under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Bordeaux
Bordeaux
Mathilde Puges, MD, +335 56 79 55 36, mathilde.puges@chu-bordeaux.fr
About this study
Official title: VIP - Vascular Infection Project : Prospective Multicentric Database on Vascular Infections
Constitution of a prospective multicentric observational database to study vascular infections, both native, especially aortitis, and vascular graft and endograft infections. Clinical and paraclinical data on medical, surgical, anesthetic and intensive care management will be collected in order to better characterize these infections
Read the detailed description
Vascular infections are rare but severe, burdened by high morbi-mortality and recurrence rates. However, many questions remain regarding their management which is still not consensual, both surgical and medical management. The term "vascular infections" encompasses vascular graft and endograft infections, as well as infections of native arteries and the aorta. For vascular graft infections, the optimal surgery is to remove the infected graft before vascular reconstruction with a new graft, either synthetic or biologic. However, some patients are too fragile to undergo surgery and might then benefit from an endovascular graft, an abscess drainage or no surgery at all, only medical treatment. For native arterial infections, surgery is often required to remove the infected arterial wall before vascular reconstruction. However, some patients cannot be operated on and might also benefit from an endovascular surgery. In these two vascular infections, the ideal anti-microbial treatment is uncertain, whether it pertains to the duration of therapy, the type of molecules, or their number. All of these medical and surgical factors may impact the prognosis of patients and should be collectively assessed in order to determine the best strategy for enhancing their outcomes.
- Keywords
- vascular graft and endograft infections, infectious aortitis, infectious arteritis
- Medical subject headings
- Aortitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Native vascular infection | Not described | |
| Prosthetic vascular infections | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality r
Measured: Year 1
Secondary outcomes (4)
mortality
mortality rate
Measured: Day 30, Year 2, Year 5
morbidity
morbidity rate
Measured: Year 1
relapse
relapse rates
Measured: year 1, Year 2, Year 5
reinfection
reinfection rates
Measured: year 1, Year 2, Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start10 May 2022
- Primary completion10 May 2032 (estimated)
- Study completion10 May 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AortitisStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866535
- Sponsor's protocol ID
- CHUBX 2022/01
- Acronym
- Cohorte VIP
- Status last verified
- Mar 2025
- First submitted
- 4 Jun 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIP - Vascular Infection Project : Prospective Multicentric Database on Vascular Infections
- ClinicalTrials.gov ID
- NCT06866535
- Acronym / sponsor ID
- Cohorte VIP / CHUBX 2022/01
- Keywords
- vascular graft and endograft infections, infectious aortitis, infectious arteritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 10 May 2032 (estimated)
- Study completion
- 10 May 2032 (estimated)
- First posted
- 10 Mar 2025 (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.
Constitution of a prospective multicentric observational database to study vascular infections, both native, especially aortitis, and vascular graft and endograft infections. Clinical and paraclinical data on medical, surgical, anesthetic and intensive care management will be collected in order to better characterize these infections
Detailed description
Vascular infections are rare but severe, burdened by high morbi-mortality and recurrence rates. However, many questions remain regarding their management which is still not consensual, both surgical and medical management. The term "vascular infections" encompasses vascular graft and endograft infections, as well as infections of native arteries and the aorta. For vascular graft infections, the optimal surgery is to remove the infected graft before vascular reconstruction with a new graft, either synthetic or biologic. However, some patients are too fragile to undergo surgery and might then benefit from an endovascular graft, an abscess drainage or no surgery at all, only medical treatment. For native arterial infections, surgery is often required to remove the infected arterial wall before vascular reconstruction. However, some patients cannot be operated on and might also benefit from an endovascular surgery. In these two vascular infections, the ideal anti-microbial treatment is uncertain, whether it pertains to the duration of therapy, the type of molecules, or their number. All of these medical and surgical factors may impact the prognosis of patients and should be collectively assessed in order to determine the best strategy for enhancing their outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Native vascular infection | – | – |
| Prosthetic vascular infections | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ents with a vascular infection, either native (aortitis, arteritis) or prosthetic (vascular graft, endograft and/or stent)
Key inclusion criteria (3 listed)
- ≥ 18 years-old;
- all patients with a vascular infection, either native (aortitis, arteritis) or prosthetic (vascular graft, endograft and/or stent),
- oral consent
Key exclusion criteria (1 listed)
- patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: Year 1
mortality r
4 secondary outcomes
mortality
Time frame: Day 30, Year 2, Year 5
morbidity
Time frame: Year 1
relapse
Time frame: year 1, Year 2, Year 5
reinfection
Time frame: year 1, Year 2, Year 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortitis and Vascular Graft Infection, run by University Hospital, Bordeaux at 1 site in France.
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 3 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Puges, MD (+335 56 79 55 36, mathilde.puges@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2025.