跳至主要内容
临床试验/NCT07113197
NCT07113197尚未招募不适用

The Diagnostic Value of Duplex Ultrasound in Evaluating Infra Inguinal Arteries in Patients With Chronic Limb Threatening Ischemia : A Comparative Study With Angiography

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Diagnostic accuracy of DUS compared to DSA in detecting ≥50% stenosis or occlusion in femoral, popliteal, and infra popliteal arteries.

研究概览

简要总结

This study aims to evaluate the accuracy of Duplex Ultrasound (DUS) in assessing infra inguinal arterial lesions in patients with chronic threatening limb ischemia compared with digital subtraction angiography (DSA) as the reference standard. By comparing sensitivity, specificity, and predictive values across arterial segments, the study seeks to determine the clinical utility of DUS as a non-invasive alternative for pre-intervention vascular mapping in chronic limb-threatening ischemia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • •Clinical diagnosis of chronic threatening lower limb ischemia (rest pain, non-healing ulcer, or gangrene).
  • •Ability to provide informed consent.

排除标准

  • •Hemodynamically unstable patients not fit for angiography.
  • •Patients with non-atherosclerotic arterial diseases (e.g., vasculitis, Buerger's disease).
  • •Known contrast allergy or renal insufficiency precluding contrast angiography.
  • •Inadequate acoustic window or inability to undergo complete DUS examination.

研究组 & 干预措施

patients with chronic threatening limb ischemia

Experimental

Duplex Ultrasound (DUS) assessment of infra inguinal arterial lesions in patients with chronic threatening limb ischemia and then compared with digital subtraction angiography (DSA) as the reference standard.

干预措施: conventional angiography (Radiation)

结局指标

主要结局

Diagnostic accuracy of DUS compared to DSA in detecting ≥50% stenosis or occlusion in femoral, popliteal, and infra popliteal arteries.

时间窗: from enrollment till angioplasty (14 days mostly)

sensitivity, specificity, positive predictive value, negative predictive value

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

Baraa Mohmamed Abdelrahman

resident doctor at sohag university hospital

Sohag University

研究点 (1)

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