The Role Of Global Limb Anatomic Staging System ( GLASS) Compared to Wound, Ischemia, Foot Infection Stage ( WIFI) in Predicting Limb Salvage After Endovascular Revascularization Procedures in Chronic Limb Threatening Ischemia Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 主要终点
- Technical Success
研究概览
简要总结
compare between GLASS and WIFI Staging in predicting limb salvage in patients with chronic limb threatening ischemia ( CLTI) undergoing endovascular revascularization.
详细描述
Peripheral arterial disease (PAD) is estimated to affect over 200 million people worldwide. These rates are expected to rise as increasing life expectancies continue to shift the population toward older age. At the most severe end of the disease spectrum, chronic limb-threatening ischemia (CLTI) affects 11% of patients with PAD and is associated with high rates of limb loss and mortality as well as high costs of care.(1) The Society for Vascular Surgery's WIfI (Wound, Ischemia, foot Infection) staging system was developed to classify threatened limbs using factors that affect amputation risk and clinical management in patients with chronic limb threatening ischemia . These include the extent of the wound, degree of ischemia, and severity of any foot infection. It has been validated as a predictor of limb salvage in peripheral artery disease.(2,3)
The Global Vascular guidelines 'GVG "proposes a new Global Anatomic Staging System (GLASS), which is a new method of quantifying the anatomic severity of infrainguinal disease in patients with chronic limb-threatening ischemia. But it has not been used for predicting limb salvage apart from use as a tool in deciding the mode of intervention for patients with chronic limb-threatening ischemia (CLTI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CLTI who will undergo endovascular revascularization at our department:
- •Rutherford stage 4 ( rest pain) ,stage 5 (ischemic ulceration not exceeding ulcer of the digits of the foot) , stage 6 ( severe ischemic ulcers or frank gangrene)
排除标准
- •Rutherford stage 1,2,3 Aortoiliac level of occlusion Unsalvageable limb Patients with contraindications to contrast media Non Atherosclerotic lschemia as • Acute ischemia
- •Post Traumatic Ischemia
- •Chronic ischemia caused by connective tissue diseases or vasculitis
结局指标
主要结局
Technical Success
时间窗: Baseline
in - line arterial flow to the foot without any flow limiting dissection or residual stenosis \> 30% on completion intraoperative arteriography
Limb Salvage
时间窗: Baseline
freedom from major amputation above the foot level
Primary Patency
时间窗: Baseline
uninterrupted vessel patency with no procedure performed on the treated limb.
Time to complete healing
时间窗: Baseline
Time to complete healing of the wound after revascularization, Debridement or minor amputation
Secondary Patency
时间窗: Baseline
an occluded artery that required intervention to restore patency.
Assisted Primary Patency
时间窗: Baseline
the percentage of failing but still patent vessel undergoing elective intervention, included patients required revision of the revascularization before vessel occlusion occurs as prophylactic interventions to maintain patency.
次要结局
未报告次要终点
研究者
Mohamed Ahmed Mohamed Bashandi
Mohamed.15235432@med.aun.edu.eg
Assiut University
