DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715452
• Other study ID #: TP-6579
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: October 2020
• Source: Osprey Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 30, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center, Emory University School of Medicine	Atlanta	Georgia
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Christ Hospital, Heart and Vascular Center, Lindner Research Center	Cincinnati	Ohio
United States	WakeMed Heart and Vascular	Raleigh	North Carolina
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Harbor UCLA Medical Center	Torrance	California
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	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	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)