Medium-term Results of Lower Limb Arterial Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged over 18 years
- •Symptomatic lower limb arterial disease
- •Undergoing revascularization bypass surgery
排除标准
- •Patients who have expressed opposition to the use of their data for research purposes
结局指标
主要结局
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.
时间窗: 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.
次要结局
未报告次要终点