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

NCT03825094 | Unknown FDA Device

• 1 other identifier: TP-6647
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 11

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.

Conditions

Patients at Risk for Developing Contrast-induced Nephropathy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

DyeVert™ Contrast Reduction Systems DEVICE

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.

Also known as: DyeVert Systems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

DyeVert Systems are indicated for patients undergoing angiographic procedures requiring injection of contrast media. Patients at risk for developing contrast-induced nephropathy (CIN) represent the target population for these devices.

You may qualify if:

• 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)

You may not qualify if:

• Required data was not collected or is not available
• In the Investigator or Sponsor's opinion, the patient is not considered to be suitable

Sponsors & Collaborators

• Osprey Medical, Inc: lead

Study Sites (11)

Hartford Healthcare

Hartford, Connecticut, 06102, United States

Location

Steward Palmetto General Hospital

Hialeah, Florida, 33016, United States

Location

Emory Healthcare

Atlanta, Georgia, 30322, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Midwest Heart & Vascular Specialists

Overland Park, Kansas, 66211, United States

Location

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

The University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

CHRISTUS Health-Westover Hills

San Antonio, Texas, 78251, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Study Officials

• Anand Prasad, MD, FACC

  UT Health Science Center San Antonio: Prof of Medicine & Director Cardiac Catheterization Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: May 7, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)