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NCT Number: NCT06963255

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Revascularization in a Septic or Potentially Septic Environment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

arterial revascularization

Procedure

arterial revascularization

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Résultats Des Allogreffes artérielles conservée à +2/+8°C Dans Les REvascularisations en MIlieu Septique

Acronym: AREMIS

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.