DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Device: DyeVert Plus Contrast Reduction System

• Registration Number: NCT03715452
• Lead Sponsor: Osprey Medical, Inc

Brief Summary

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.

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 Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-01-31
• Study Completion: 2018-03-30
• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-19
• Study First Posted: 2018-10-23
• Results First Submitted: 2019-01-30
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-15
• Last Update Submitted: 2020-10-15
• Results First Posted: 2020-10-19
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DyeVert Plus Contrast Reduction System	DyeVert Plus Contrast Reduction System	DyeVert Plus Contrast Reduction System

Primary Outcome Measures

Name	Time	Method
Percentage of Contrast Media Volume Saved	At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Adverse Events Through Discharge (From the Index Procedure)	From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days)	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.

Trial Locations

Locations (8)

Christ Hospital, Heart and Vascular Center, Lindner Research Center; 🇺🇸 Cincinnati, Ohio, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

North Mississippi Medical Center; 🇺🇸 Tupelo, Mississippi, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Harbor UCLA Medical Center; 🇺🇸 Torrance, California, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Atlanta VA Medical Center, Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

WakeMed Heart and Vascular; 🇺🇸 Raleigh, North Carolina, United States