跳至主要内容
临床试验/NCT03825094
NCT03825094Unknown不适用

DyeVert™ System Use for Contrast Monitoring and Minimization in At-Risk Patients Undergoing Angiography Procedures: A Real-World Registry (DyeMINISH Registry)

Osprey Medical, Inc11 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2019年5月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10,000
试验地点
11
主要终点
Evaluate incidence of adverse events associated with index cath lab procedures in which the DyeVert System was used

研究概览

简要总结

The purpose of this registry-based study is to evaluate the ongoing, real-world clinical performance and safety of commercially available DyeVert Systems during typical clinical use for patients undergoing coronary or peripheral angiography for diagnostic and/or interventional procedures.

详细描述

Contrast-induced acute kidney injury (CI-AKI) occurs in 3-19% of patients undergoing coronary angiography and is associated with increased morbidity, mortality, and healthcare costs. Patients with chronic kidney disease have greater odds of developing CI-AKI. Guidelines for CI-AKI prevention include screening for risk, volume expansion, and minimizing contrast media volume (CMV) to the patient during angiography; however, hospitals face barriers to implementation in the real-world setting and therefore consistent care delivery for at-risk patients remains a modern clinical challenge. DyeVert Systems provide real-time CMV monitoring and minimization during angiography procedures thereby reducing total CMV to the patient and total CMV relative to baseline renal function, two known risk factors for CI-AKI. The DyeMINISH Registry is designed to evaluate ongoing real-world clinical performance and safety of commercially available DyeVert Systems among a large, real-world population of patients undergoing coronary and peripheral angiography.

研究设计

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

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

  • DyeVert Group Patients: Patient underwent a diagnostic and/or interventional angiography procedure in which the DyeVert System was used in a majority of the case
  • Patient is willing and able to provide appropriate informed consent (if required)

排除标准

  • Required data was not collected or is not available
  • In the Investigator or Sponsor's opinion, the patient is not considered to be suitable

结局指标

主要结局

Evaluate incidence of adverse events associated with index cath lab procedures in which the DyeVert System was used

时间窗: Index procedure through 120 days post index procedure

Evaluate contrast media volume (CMV) threshold setting practices and contrast media (CM) usage during index cath lab procedures in which the DyeVert System was used

时间窗: Index procedure

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (11)

Loading locations...

相似试验