DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

Minimizing Radiographic Contrast Administration During Coronary Angiography Using a Novel Contrast Reduction System: A Multicenter Observational Study of the DyeVert™ Plus Contrast Reduction System

This is a prospective, single arm, multi-center, observational clinical study of the DyeVert Plus System. The DyeVert Plus System is an FDA-cleared device designed to reduce contrast media volume delivered during angiography and permit real-time contrast media volume monitoring.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Device: DyeVert Plus Contrast Reduction System

Detailed Description

The purpose of this observational study is to evaluate the amount of contrast media saved using DyeVert Plus in coronary angiographic and/or interventional procedures performed with manual injection and evaluate the impact of predetermined thresholds and real-time monitoring.

• Study Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90509
      • Harbor Ucla Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Atlanta VA Medical Center, Emory University School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • North Carolina
    • Raleigh, North Carolina, United States, 27518
      • Wakemed Heart and Vascular
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital, Heart and Vascular Center, Lindner Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects undergoing diagnostic coronary angiography (CAG) and/or percutaneous coronary interventional (PCI) procedures performed with manual injections

Description

Inclusion Criteria:

• Scheduled to undergo CAG and/or PCI
• Baseline estimated glomerular filtration rate (eGFR) of ≥20 and ≤60 mL/ min/1.73 m2

Exclusion Criteria:

• Acute ST-elevation myocardial infarction or known coronary artery fistulas
• Body mass index (BMI) >40
• Currently pregnant
• Undergoing a chronic total occlusion procedure or optical coherence tomography analysis
• Planning to undergo transcatheter aortic valve replacement within 72 hr of the index procedure
• A condition known to require large volumes of contrast (>10 mL) for each injection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

DyeVert Plus Contrast Reduction System

Device: DyeVert Plus Contrast Reduction System; The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Contrast Media Volume Saved	The percentage of contrast media volume saved (diverted) over the total procedure as reported on the DyeVert Plus display at the end of each case.	At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Adverse Events Through Discharge (From the Index Procedure)	An adverse event is defined as "any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device." DyeVert Plus System-related adverse events will be collected. Additionally, contrast media-related adverse events, such as acute kidney injury and anaphylactic shock, will be collected.	From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days)

Collaborators and Investigators

• Sponsor: Osprey Medical, Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: TP-6579

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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.: No