Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions in Patients With Chronic Lower Limb Threatening Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- sustained clinical improvement.
研究概览
简要总结
The purpose of this study is to evaluate the technical feasibility, safety, and 1-year clinical efficacy of the endovascular treatment of patients with atherosclerotic common femoral artery (CFA) obstructions with associated superficial femoral artery lesions. Participants will undergo angioplasty with or without stenting of common femoral and superficial femoral arteries.
详细描述
Study design:
It is a prospective study which will include patients who need revascularization after approval of this study from local ethical committee and obtaining written informed consent.
Study setting:
This study will be done in Sohag University Hospitals and in Cairo University Hospitals.
Study sample:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum creatinine <
- •Complaining of chronic lower limb threatening ischemia due to denovo atherosclerotic disease i.e. no previous intervention of common femoral artery with associated superficial femoral artery lesion (Rutherford stages 2-5).
排除标准
- •- Non-atherosclerotic conditions (for example: vasculitis, collagen vascular disease, Buerger's disease, radiation).
- •Acute limb ischemia.
结局指标
主要结局
sustained clinical improvement.
时间窗: 1 year
a sustained upward shift of ≥1 category of the Rutherford classification without the need for repeated target lesion revascularization in surviving patients.
次要结局
未报告次要终点
研究者
Hossam Eldin AHmed Soliman
Hossam Eldin Ahmed Soliman Mohamed
Sohag University