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临床试验/NCT05689190
NCT05689190终止不适用

Non-invasive Flow Measurements in Patients With Lower Extremity Arterial Disease (LEAD)

Philips Clinical & Medical Affairs Global2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
29
试验地点
2
主要终点
blood flow

研究概览

简要总结

This concerns a study with patients who will undergo endovascular treatment. Blood flow will be measured by 2D Duplex Ultrasound. Contrast data will be collected that will be processed offline.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred to the vascular surgery outpatient clinic (LUMC) with PAD
  • Age ≥18 years
  • Superficial femoral artery (SFA) stenosis (>70% occluded)
  • Elective for a percutaneous transluminal angioplasty procedure
  • Written informed consent

排除标准

  • Contraindications to angiography, such as severe renal insufficiency (eGFR< 20)
  • Non-correctable bleeding disorder.

结局指标

主要结局

blood flow

时间窗: performed during a regular PTA intervention

Repeatability and correlation of angiographic hemodynamic measurements compared with the golden standard 2D duplex ultrasound.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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