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

Osprey Medical

Status: Unknown

Conditions: Patients at Risk for Developing Contrast-induced Nephropathy

Treatments: Device: DyeVert™ Contrast Reduction Systems

Study type: Observational

Funder types: Industry

Identifiers

NCT03825094

TP-6647

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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