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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Patients at Risk for Developing Contrast-induced Nephropathy
• Intervention / Treatment: Device: DyeVert™ Contrast Reduction Systems

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Healthcare
  • Florida
    • Hialeah, Florida, United States, 33016
      • Steward Palmetto General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Healthcare
    • Decatur, Georgia, United States, 30033
      • Atlanta VA Medical Center
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Midwest Heart & Vascular Specialists
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Healthcare
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Texas
    • San Antonio, Texas, United States, 78229
      • The University of Texas Health Science Center
    • San Antonio, Texas, United States, 78251
      • CHRISTUS Health-Westover Hills
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • St. Mary's Medical Center
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

DyeVert Systems are indicated for patients undergoing angiographic procedures requiring injection of contrast media. Patients at risk for developing contrast-induced nephropathy (CIN) represent the target population for these devices.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Index procedure
Evaluate incidence of adverse events associated with index cath lab procedures in which the DyeVert System was used	Index procedure through 120 days post index procedure

Collaborators and Investigators

• Sponsor: Osprey Medical, Inc
• Investigators: Principal Investigator: Anand Prasad, MD, FACC, UT Health Science Center San Antonio: Prof of Medicine & Director Cardiac Catheterization Laboratory

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2019
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (ACTUAL): January 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: TP-6647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes