NCT03825094

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Osprey Medical, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-07
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-01-31
• Last updated: 2022-04-18

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study