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临床试验/NCT05436470
NCT05436470Temporarily Not Available不适用

Treatment (Compassionate) Use of Device - PK Papyrus

University of Miami2 个研究点 分布在 1 个国家开始时间: 2022年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
Temporarily Not Available
试验地点
2

研究概览

简要总结

The purpose of this study is to evaluate the clinical use of the PK Papyrus Coronary Stent Graft System, a Humanitarian Use Device (HUD) approved by the FDA under a Humanitarian Device Exemption.

研究设计

研究类型
Expanded Access

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

  • 1. Patients with traumatic, dissecting, pseudo, or other wide based aneurysms in non-perforator territories or fistulas of the extracranial or intracranial segments of the internal carotid or vertebral artery.

排除标准

  • Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
  • Adults who are cognitively impaired, pregnant women, and prisoners.

研究者

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

Robert Starke

Associate Professor

University of Miami

研究点 (2)

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