跳至主要内容
临床试验/NL-OMON51566
NL-OMON51566尚未招募不适用

FLowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) - FLASH study

Inari Medical Europe GmbH0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
12

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • 1. Age >= 18 years
  • 2. Clinical signs and symptoms consistent with acute pulmonary embolism (PE)
  • 3. Echo, CTPA, or pulmonary angiographic evidence of proximal filling defect in
  • at least one main or lobar pulmonary artery
  • 4. Scheduled for PE treatment with the FlowTriever System per the
  • Investigator*s discretion

排除标准

  • 1. Unable to anticoagulate with heparin or alternative
  • 2. Diagnosed with a minor PE with less than a 0.9 RV/LV ratio
  • 3. Known sensitivity to radiographic contrast agents that, in the
  • Investigator*s opinion, cannot be adequately pre-treated
  • 4. Imaging evidence or other evidence that suggests, in the opinion of the
  • Investigator, the patient is not appropriate for mechanical thrombectomy
  • intervention (e.g., inability to navigate to target location or predominately
  • chronic clot)
  • 5. Life expectancy < 30 days, as determined by the Investigator
  • 6. Current participation in another investigational drug or device treatment
  • study that, in the investigator*s opinion, would interfere with participation
  • in this study

研究者

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