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临床试验/NCT04693767
NCT04693767已完成不适用

Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

Penumbra Inc.27 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年2月16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
Penumbra Inc.
入组人数
400
试验地点
27
主要终点
Blood and Clot Specimen Transcriptomics

研究概览

简要总结

The aim of the study is to collect and analyze specimen from ischemic stroke patients undergoing thrombectomy procedures and from patients undergoing minimally invasive surgery for intracranial hematoma evacuation.

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

入选标准

  • ≥ 18 Years of Age
  • Frontline treatment with: Penumbra System for ischemic stroke patients eligible for mechanical thrombectomy or Artemis Neuro Evacuation device for intracranial hematoma evacuation in patients eligible for minimally invasive surgery (MIS)
  • Extracted thrombus/embolus
  • Informed consent is obtained from either the patient or legally authorized representative (LAR)

排除标准

  • Pregnancy or positive pregnancy test according to site routine practice (only required for women of child bearing potential; serum or urine acceptable)
  • Currently participating in an investigational drug or device clinical trial that may confound the ability to capture clot and/or influence clot composition. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible

结局指标

主要结局

Blood and Clot Specimen Transcriptomics

时间窗: Blood and clot specimen obtained during procedure

Numbers of blood and clot for RNA sequency. Only includes successful sample number that was processed.

Blood and Clot Specimen Proteomics

时间窗: Blood and clot specimen obtained during procedure

Numbers of blood and clot specimen for proteomic analysis

Clot Specimen Histology

时间窗: Clot specimen obtained during procedure

Numbers of clot specimen for histology analysis

Blood and Clot Specimen Genomics

时间窗: Blood and clot specimen obtained during procedure

Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs). Only includes successful sample number that was processed.

次要结局

未报告次要终点

研究者

发起方
Penumbra Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (27)

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