DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

Osprey Medical

Status

Completed

Conditions

Chronic Kidney Disease

Treatments

Device: DyeVert Plus Contrast Reduction System

Study type

Observational

Funder types

Industry

Identifiers

NCT03715452

TP-6579

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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