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

Patients at Risk for Developing Contrast-induced Nephropathy Clinical Trial

— DyeMINISH  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03825094
• Other study ID #: TP-6647
• Status: Enrolling by invitation
• Start date: May 7, 2019
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Osprey Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Patients at Risk for Developing Contrast-induced Nephropathy

Intervention

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.

Locations

Country	Name	City	State
United States	Emory Healthcare	Atlanta	Georgia
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	St. Elizabeth Healthcare	Edgewood	Kentucky
United States	Hartford Healthcare	Hartford	Connecticut
United States	Steward Palmetto General Hospital	Hialeah	Florida
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	West Virginia University	Morgantown	West Virginia
United States	Midwest Heart & Vascular Specialists	Overland Park	Kansas
United States	CHRISTUS Health-Westover Hills	San Antonio	Texas
United States	The University of Texas Health Science Center	San Antonio	Texas
United States	North Mississippi Medical Center	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Osprey Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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