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

NCT ID: NCT06963255

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-03

Study Completion Date

2028-01-01

Brief Summary

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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

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Conditions

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Revascularization in a Septic or Potentially Septic Environment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

arterial revascularization

Intervention Type PROCEDURE

arterial revascularization

Interventions

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arterial revascularization

arterial revascularization

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status

HCL hopital Louis Pradel

Bron, , France

Site Status

Countries

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France

Other Identifiers

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23-5415

Identifier Type: -

Identifier Source: org_study_id

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