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Medium-term Results of Lower Limb Arterial Bypass

NCT07093632 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2025-07-30

No results posted yet for this study

Summary

Peripheral arterial occlusive disease (PAOD) is a condition affecting the arteries of the lower limbs, caused by the progressive accumulation of lipid deposits that obstruct blood vessels. At an advanced stage, PAOD may progress to critical limb ischemia (CLI), characterized by persistent pain, chronic wounds, or gangrene. This situation constitutes a medical emergency, as it may result in limb loss or threaten the life of the patient.

In this context, arterial revascularization is essential to restore adequate blood flow to the tissues. Among therapeutic options, arterial bypass surgery remains a reference strategy. The choice of bypass type, the material used (autologous vein or prosthetic graft), perioperative conditions, and clinical characteristics of patients significantly influence the success of the intervention and both short- and long-term outcomes.

When an autologous vein is not available, the use of cold-stored allogeneic vein grafts has been proposed as an alternative. Several studies have evaluated their performance, showing encouraging results in terms of graft patency and limb salvage in patients with CLI. More recently, the REVATEC study confirmed these observations in a multicenter setting in France, highlighting the feasibility and safety of this technique in routine clinical practice\].

Thus, a better understanding of the factors associated with the performance of arterial bypasses and the clinical evolution of patients in real-world practice is essential to optimize management strategies.

This retrospective study aims to analyze the clinical and technical data related to arterial bypass procedures performed in patients presenting with CLI. Data will be collected at various stages of the care pathway: preoperative phase, surgical intervention, hospitalization, discharge, and 1-year follow-up. The analysis will include consecutive medical records of patients operated on between January 2018 and February 2024.

Conditions

  • Peripheral Arterial Occlusive Disease
  • Critical Limb Ischemia
  • Arterial Revascularization
  • Arterial Bypass Surgery

Interventions

PROCEDURE

Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb.

This study concerns adult subjects with symptomatic lower limb arterial disease who have undergone arterial bypass surgery and are included in the study cohort. Graft dysfunction will be assessed through clinical examination and imaging follow-up to detect occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the treated limb.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-01-01
Completion
2025-04-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093632 on ClinicalTrials.gov