Outcomes of Arterial Allografts Preserved at +2 to +8°C for Revascularization in Septic Settings (AREMIS)

Civil Hospices of Lyon

Status: Active, not recruiting

Conditions: Revascularization in a Septic or Potentially Septic Environment

Treatments: Procedure: arterial revascularization

Study type: Observational

Funder types: Other

Identifiers

NCT06963255

23-5415

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Pregnant women
• Individuals for whom regular medical follow-up cannot be ensured

Trial design

40 participants in 1 patient group

The study group will include all patients requiring bypass revascularization in a septic or high-ris

Description:

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

Treatment:

Procedure: arterial revascularization