DyeVert™ System for Contrast Monitoring in At-Risk Patients Undergoing Angiography: A Real-World Registry
- Conditions
- Patients at Risk for Developing Contrast-induced Nephropathy
- Registration Number
- NCT03825094
- Lead Sponsor
- Osprey Medical, Inc
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10000
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Steward Palmetto General Hospital
🇺🇸Hialeah, Florida, United States
Emory Healthcare
🇺🇸Atlanta, Georgia, United States
Midwest Heart & Vascular Specialists
🇺🇸Overland Park, Kansas, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Hartford Healthcare
🇺🇸Hartford, Connecticut, United States
St. Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, 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
Atlanta VA Medical Center
🇺🇸Decatur, Georgia, United States