跳至主要内容
临床试验/NCT02646150
NCT02646150已完成不适用

Clinical Use of Magnetic Resonance Perfusion Imaging to Qualitatively Assess Adequate Distal Perfusion After Endovascular Revascularization in Critical Limb Ischemia

Seung-Whan Lee, M.D., Ph.D.1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2015年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
The change of deoxyhemoglobin in MR imaging

研究概览

简要总结

This study evaluates the clinical effectiveness of Magnetic Resonance(MR) perfusion imaging to qualitatively assess adequate distal perfusion after endovascular revascularization in Critical Limb Ischemia

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age 20 and above
  • Critical limb ischemia with ulcer
  • Ankle brachial index(ABI) ≤ 0.9 or Toe brachial index (TBI) ≤ 0.5 or Transcutaneous oxygen pressure (TcPo2) ≤ 40mmHg
  • ≥ 70 percentage of stenosis of infrapopliteal artery on lower extremity computed tomography angiography or lower extremity doppler
  • Subject understands protocol and provides written, informed consent

排除标准

  • Post-traumatic critical limb ischemia
  • Neurogenic limb ischemia
  • Life expectancy ≤ 2 years

结局指标

主要结局

The change of deoxyhemoglobin in MR imaging

时间窗: 6 months

次要结局

  • The event rate of unplanned major and minor amputation in limb(6 months)
  • The event rate of complete healing of lower extremity ulcer(6 months)

研究者

发起方
Seung-Whan Lee, M.D., Ph.D.
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seung-Whan Lee, M.D., Ph.D.

Division of Cardiology

Asan Medical Center

研究点 (1)

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