跳至主要内容
临床试验/NCT06600542
NCT06600542招募中不适用

Inari VISION Registry

Inari Medical15 个研究点 分布在 3 个国家目标入组 1,000 人开始时间: 2025年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Inari Medical
入组人数
1,000
试验地点
15
主要终点
Incidence of device-related, procedure-related, or fatal Adverse Events

研究概览

简要总结

This registry is a global prospective, non-randomized, multicenter, observational, active post-market data collection of Inari Medical devices and products.

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

  • Willing and able to provide informed consent per institution and geographical requirements
  • Has received treatment with an eligible Inari Medical device. NOTE: If patients are consented prior to their procedure and the procedure does not take place, the patient will be considered a screen failure.
  • Currently within enrollment window relative to their procedure
  • Age ≥ 18 years

排除标准

  • Is or will be inaccessible for registry follow-up
  • Meets exclusion criteria required by local requirements
  • Current or planned participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this registry
  • Is pregnant or breastfeeding at the time of enrollment

结局指标

主要结局

Incidence of device-related, procedure-related, or fatal Adverse Events

时间窗: Up to 180 days

次要结局

未报告次要终点

研究者

发起方
Inari Medical
申办方类型
Industry
责任方
Sponsor

研究点 (15)

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