Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-01 @ 8:05 AM
Study NCT ID:
NCT07093632
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2025-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medium-term Results of Lower Limb Arterial Bypass
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Medium-term Results of Lower Limb Arterial Bypass
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MERLLAB
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.
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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: