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.
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
10,000
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.
Hartford Healthcare
Hartford, Connecticut, United States
Steward Palmetto General Hospital
Hialeah, Florida, United States
Emory Healthcare
Atlanta, Georgia, United States
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
Time frame: Index procedure
Evaluate incidence of adverse events associated with index cath lab procedures in which the DyeVert System was used
Time frame: Index procedure through 120 days post index procedure
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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
...and 1 more locations