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Active, not recruiting Observational

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

NCT06963255 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-06-03
Last updated
2025-05-08

Condition(s) studied

Revascularization in a Septic or Potentially Septic Environment

Investigational drug(s) / intervention(s)

arterial revascularization

arterial revascularization: arterial revascularization

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (2)

FacilityCityRegionStatus
CHU de Bordeaux Bordeaux France
HCL hopital Louis Pradel Bron France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06963255 on ClinicalTrials.gov ↗ ← All trials in France