Clinical trial NCT03715452: DyeVert™ Plus Contrast Reduction System Multicenter Observational Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Lead sponsor: Osprey Medical, Inc
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Contrast Media Volume Saved
timeFrame: At the time of the coronary angiography (CAG) or percutaneous coronary interventional (PCI) procedure
Secondary outcomes:
measure: Evaluation of Adverse Events Through Discharge (From the Index Procedure)
timeFrame: From the time of the procedure through discharge (from the index procedure, approximately 0 - 3 days)
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Atlanta
country: United States
facility: Atlanta VA Medical Center, Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Raleigh
country: United States
facility: WakeMed Heart and Vascular
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital, Heart and Vascular Center, Lindner Research Center
state: Ohio
Study officials:
References: