An observational study in Revascularization in a Septic or Potentially Septic Environment, sponsored by Hospices Civils de Lyon. Active, not recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Hospices Civils de Lyon · Observational
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.
Hospices Civils de Lyon is the lead sponsor of 1,856 studies on the registry; 442 are open to participants now.
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The target population includes 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
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Exclusion Criteria:
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
Procedure: arterial revascularization
arterial revascularization
To evaluate the 6-month primary patency of revascularizations using arterial allografts preserved at +2 to +8°C
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
Time frame: 6 month
Started Jun 2024 (actual). Primary completion is estimated for Dec 2025, 17 months after the start.
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This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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