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DyeVert™ System for Contrast Monitoring in At-Risk Patients Undergoing Angiography: A Real-World Registry

NCT03825094 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2022-04-18

No results posted yet for this study

Summary

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.

Conditions

  • Patients at Risk for Developing Contrast-induced Nephropathy

Interventions

DEVICE

DyeVert™ Contrast Reduction Systems

Osprey Medical DyeVert™ Contrast Reduction Systems (DyeVert Systems) provide fluid pathway resistance modulation such that excess contrast media (CM) (i.e. CM that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast media volume (CMV) reduction occurs, while maintaining adequate image quality.

Sponsors & Collaborators

  • Osprey Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Anand Prasad, MD, FACC · UT Health Science Center San Antonio: Prof of Medicine & Director Cardiac Catheterization Laboratory

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03825094 on ClinicalTrials.gov