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

NCT ID: NCT03825094

Last Updated: 2022-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-07
• Study Completion Date: 2023-12-31

Brief 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.

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.

Conditions

Patients at Risk for Developing Contrast-induced Nephropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

DyeVert Systems

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osprey Medical, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anand Prasad, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

UT Health Science Center San Antonio: Prof of Medicine & Director Cardiac Catheterization Laboratory

Locations

Hartford Healthcare

Hartford, Connecticut, United States

Steward Palmetto General Hospital

Hialeah, Florida, United States

Emory Healthcare

Atlanta, Georgia, United States

Atlanta VA Medical Center

Decatur, Georgia, United States

Midwest Heart & Vascular Specialists

Overland Park, Kansas, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

The University of Texas Health Science Center

San Antonio, Texas, United States

CHRISTUS Health-Westover Hills

San Antonio, Texas, United States

St. Mary's Medical Center

Huntington, West Virginia, United States

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

TP-6647

Identifier Type: -

Identifier Source: org_study_id