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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03825094
Recruitment Status : Enrolling by invitation
First Posted : January 31, 2019
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Patients Undergoing Cardiac Angiography Who Are at Risk for Contrast Induced Acute Kidney Injury Device: DyeVert™ Contrast Reduction Systems

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: DyeVert™ System Use for Contrast Monitoring and Minimization in At-Risk Patients Undergoing Angiography Procedures: A Real-World Registry (DyeMINISH Registry)
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Intervention Details:
  • 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.
    Other Name: DyeVert Systems


Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825094


Locations
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United States, Connecticut
Hartford Healthcare
Hartford, Connecticut, United States, 06102
United States, Florida
Palmetto General Hospital
Hialeah, Florida, United States, 33016
United States, Georgia
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
United States, Kansas
Midwest Heart & Vascular Specialists
Overland Park, Kansas, United States, 66211
United States, Kentucky
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
United States, Mississippi
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
United States, Texas
The University of Texas Health Science Center
San Antonio, Texas, United States, 78229
United States, West Virginia
St. Mary's Medical Center
Huntington, West Virginia, United States, 25702
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Osprey Medical, Inc
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Responsible Party: Osprey Medical, Inc
ClinicalTrials.gov Identifier: NCT03825094    
Other Study ID Numbers: TP-6647
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases