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临床试验/NCT06209866
NCT06209866尚未招募不适用

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

Assiut University0 个研究点目标入组 28 人开始时间: 2024年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ahmed Mohamed Bashandi

Mohamed.15235432@med.aun.edu.eg

Assiut University

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