DyeVert™ Plus Contrast Reduction System Multicenter Observational Study

NCT03715452 | Completed Results FDA Device

• 1 other identifier: TP-6579
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 8

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (1)

DyeVert Plus Contrast Reduction System

DyeVert Plus Contrast Reduction System

Device: DyeVert Plus Contrast Reduction System

Interventions

DyeVert Plus Contrast Reduction System DEVICE

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.

DyeVert Plus Contrast Reduction System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osprey Medical, Inc: lead

Study Sites (8)

Harbor UCLA Medical Center

Torrance, California, 90509, United States

Location

Atlanta VA Medical Center, Emory University School of Medicine

Atlanta, Georgia, 30308, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

WakeMed Heart and Vascular

Raleigh, North Carolina, 27518, United States

Location

Christ Hospital, Heart and Vascular Center, Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vice President of Clinical Affairs
• Organization: Osprey Medical, Inc.

kknish@ospreymed.com

952.955.8236

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 23, 2018
• Study Start: July 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: March 30, 2018
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)