Revascularization in a Septic or Potentially Septic EnvironmentAREMISNCT06963255
Outcomes of Arterial Allografts Preserved at +2 to +8°C for Revascularization in Septic Settings
An observational study of Revascularization in a Septic or Potentially Septic Environment, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
This study does not modify patient management or treatment. All patients undergoing treatment with an arterial allograft preserved at +2/+8°C as part of an arterial revascularization in a septic environment in either of the two centers between January 2024 and January 2025 will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revascularization in a Septic or Potentially Septic Environment
- What is being tested?
- arterial revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Jun 2024to 1 Jan 2028
- 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
- Adult, Older adult
Study population: The target population includes all patients requiring bypass revascularization in a septic or high-risk septic environment, for whom a biomaterial is preferred over a prosthetic graft due to the unavailability of the patient's autologous saphenous vein
Who may be able to join
- Adult patient
- Requiring revascularization in a septic or high-risk septic environment
- With an estimated life expectancy of 12 months or more based on medical and surgical assessment
- Informed about the study
Who cannot join
- Pregnant women
- Individuals for whom regular medical follow-up cannot be ensured
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Bordeaux
Bordeaux, 33076
HCL hopital Louis Pradel
Bron, 69500
About this study
Official title: Résultats Des Allogreffes artérielles conservée à +2/+8°C Dans Les REvascularisations en MIlieu Septique
This study does not modify patient management or treatment. All patients undergoing treatment with an arterial allograft preserved at +2/+8°C as part of an arterial revascularization in a septic environment in either of the two centers between January 2024 and January 2025 will be included.
Imaging exams and clinical follow-up data will be analyzed. Reinterventions and causes of death will be recorded. All imaging required for the 6-month follow-up is routinely performed as part of standard care. No modification of patient management is planned.
- Being tested
- arterial revascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial revascularizationProcedure or surgery
arterial revascularization
| Study group | Role | What they receive |
|---|---|---|
| The study group will include all patients requiring bypass revascularization in a septic or high-ris | The study group will include all patients requiring bypass revascularization in a septic or high-risk septic environment, for whom a biomaterial is preferred over a prosthetic graft due to the unavailability of the patient's autologous saphenous vein Receives: Procedure: arterial revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the 6-month primary patency of revascularizations using arterial allografts preserved at +2 to +8°C
Evaluation of the 6-month primary patency of the revascularization, defined as the percentage of patients with a patent bypass without reintervention or >50% stenosis, confirmed by a morphological imaging exam (Doppler ultrasound or CT angiography) performed at 6 months
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start3 Jun 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revascularization in a Septic or Potentially Septic EnvironmentStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963255
- Sponsor's protocol ID
- 23-5415
- Acronym
- AREMIS
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Résultats Des Allogreffes artérielles conservée à +2/+8°C Dans Les REvascularisations en MIlieu Septique
- ClinicalTrials.gov ID
- NCT06963255
- Acronym / sponsor ID
- AREMIS / 23-5415
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 8 May 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.
This study does not modify patient management or treatment. All patients undergoing treatment with an arterial allograft preserved at +2/+8°C as part of an arterial revascularization in a septic environment in either of the two centers between January 2024 and January 2025 will be included.
Imaging exams and clinical follow-up data will be analyzed. Reinterventions and causes of death will be recorded. All imaging required for the 6-month follow-up is routinely performed as part of standard care. No modification of patient management is planned.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study group will include all patients requiring bypass revascularization in a septic or high-ris | – | Procedure: arterial revascularizationThe study group will include all patients requiring bypass revascularization in a septic or high-risk septic environment, for whom a biomaterial is preferred over a prosthetic graft due to the unavailability of the patient's autologous saphenous vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The target population includes all patients requiring bypass revascularization in a septic or high-risk septic environment, for whom a biomaterial is preferred over a prosthetic graft due to the unavailability of the patient's autologous saphenous vein
Key inclusion criteria (4 listed)
- Adult patient
- Requiring revascularization in a septic or high-risk septic environment
- With an estimated life expectancy of 12 months or more based on medical and surgical assessment
- Informed about the study
Key exclusion criteria (2 listed)
- Pregnant women
- Individuals for whom regular medical follow-up cannot be ensured
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 |
|---|---|---|
| arterial revascularizationarterial revascularization | Procedure or surgery | The study group will include all patients requiring bypass revascularization in a septic or high-ris |
Primary outcome
To evaluate the 6-month primary patency of revascularizations using arterial allografts preserved at +2 to +8°C
Time frame: 6 month
Evaluation of the 6-month primary patency of the revascularization, defined as the percentage of patients with a patent bypass without reintervention or >50% stenosis, confirmed by a morphological imaging exam (Doppler ultrasound or CT angiography) performed at 6 months
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 8 May 2025.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Revascularization in a Septic or Potentially Septic Environment, run by Hospices Civils de Lyon at 2 sites 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
To evaluate the 6-month primary patency of revascularizations using arterial allografts preserved at +2 to +8°C (time frame: 6 month). 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 8 May 2025.