Medium-term Results of Lower Limb Arterial Bypass

Completed

• Conditions: Peripheral Arterial Occlusive Disease; Critical Limb Ischemia; Arterial Revascularization; Arterial Bypass Surgery

• Registration Number: NCT07093632
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-04-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-07-30
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Adults aged over 18 years
• Symptomatic lower limb arterial disease
• Undergoing revascularization bypass surgery

Exclusion Criteria

• Patients who have expressed opposition to the use of their data for research purposes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the incidence of arterial bypass graft dysfunction, defined by the occurrence of at least one of the following events: occlusion, pseudoaneurysm, aneurysm rupture, infection, or major amputation of the target limb.	The primary outcome will be assessed at 1-year follow-up	The primary endpoint, graft dysfunction, will be evaluated through thorough clinical examinations combined with scheduled imaging assessments. These evaluations aim to identify any occurrence of occlusion, pseudoaneurysm formation, aneurysm rupture, infection, or major amputation of the treated limb. This comprehensive approach ensures early detection and accurate characterization of graft-related complications.

Trial Locations

Locations (1)

Louis Pradel Cardiology Hospital; 🇫🇷 Lyon, France