Outcomes of Arterial Allografts Preserved at +2 to +8°C for Revascularization in Septic Settings
- Conditions
- Revascularization in a Septic or Potentially Septic Environment
- Registration Number
- NCT06963255
- Lead Sponsor
- Hospices Civils de Lyon
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- Pregnant women
- Individuals for whom regular medical follow-up cannot be ensured
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the 6-month primary patency of revascularizations using arterial allografts preserved at +2 to +8°C 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
CHU de Bordeaux
🇫🇷Bordeaux, France
HCL hopital Louis Pradel
🇫🇷Bron, France