The Future of the Revascularization Using a Bioprotec Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The Limb rescue rate one year after a BIOPROTEC graft
研究概览
简要总结
The main purpose of this study is the rate assessment of rescued limbs, one year after a BIOPROTEC vascular graft.
详细描述
The BIOPROTEC grafts are controverted: they are useful in some cases, but they are known as frequently broken or thrombosed. However they are always posed in a complicated situations, in a fragile patients who have ever had many of revascularizations or in an infectious state (which is supportive of the pseudoaneurysm and thrombosis) Despite the frequent use of this graft in France, the results have never been published.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ Eighteen years old.
- •Critical ischemia (Phase 4-6 of Rutherford): no saphenous equipment for the vascular reconstruction; at least one leg axis permeable.
排除标准
- •Pregnant woman.
- •Patient with an acute ischemia.
- •Patient with an exceeded ischemia.
结局指标
主要结局
The Limb rescue rate one year after a BIOPROTEC graft
时间窗: Two years
Usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular doctor in 1 month, 6 months, 12 months, 18 months and 2 years
次要结局
- The amputation rate(Two years)
- The revascularization permeability rate(Two years)
- Infection resistance rate(Two years)