Revascularization of Single Versus Multiple Infrapopliteal Vesseles in Chronic Limb Threatening Ischemia : Limb Salvage Rate
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- limb salvage rate
研究概览
简要总结
This interventional prospective study aims to assess the effectiveness of single vessel versus multiple vessel infrapopliteal angioplasty in patients with chronic threatening limb ischemia . The study compares limb salvage rates and clinical outcomes across two groups over a defined follow up period
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
due to nature of the intervention procedures masking was not feasible the number of infrapopliteal arteries treated is clearly documented in procedural reports and imaging and therefore both participants and treating physicians were aware of the assigned intervention
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 40 years or older
- •patients with Rutherford category "4" and "5"
- •patients with angiographic evidence of infrapopliteal vessel occlusive disease -
排除标准
- •patients who refuse to participate in the study
- •patients with isolated proximal arterial disease (e.g SFA or popliteal ) without infrapopliteal involvement
- •patients who develop acute thrombosis , flow limiting dissection or perforation in the infrapopliteal arteries during intervention -
研究组 & 干预措施
three vessel revascularization
patients in this group will undergo will receive angioplasty of all three infrapopliteal arteries
干预措施: balloon angioplasty (Procedure)
two vessel revascularization
patients in this group will undergo will receive angioplasty of two infrapopliteal arteries
干预措施: balloon angioplasty (Procedure)
single vessel revascularization
patients in this group will undergo will receive angioplasty of only one infrapopliteal artery
干预措施: balloon angioplasty (Procedure)
结局指标
主要结局
limb salvage rate
时间窗: 6 months ( with optional follow up at 12 months )
percentage of patients who remain free from major lower limb amputation during the period of follow up after angioplasty
次要结局
未报告次要终点
研究者
Mahmoud Abdelrahman Hafez
Mahmoud Abdelrahman Hafez
Sohag University