REduction of Contrast Via DyeVert Used in CTO Procedures

REduction of Contrast Via DyeVert Used in CTO Procedures (REDUCe)

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03118544

Acronym

REDUCe

Enrollment

Registered

2017-04-18

Start date

2017-03-26

Completion date

2018-02-02

Last updated

2018-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Total Occlusion of Coronary Artery

Keywords

Chronic Total Occlusion, Coronary Artery Disease, Percutaneous Coronary Intervention, CTO, PCI

Brief summary

The is an observational, prospective study to evaluate the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)

Detailed description

The DyeVert System is a disposable, FDA-approved device that interfaces with standard manifold systems to reduce the amount of contrast used in catheterization procedures, while maintaining fluoroscopic image opacity. No study has assessed use of the system in CTO PCI. It would be expected that savings in CTO procedures may be less than non-CTO procedures due to catheter sizing and number of open guide injections required. Open guide injections through larger catheters do not provide for the as much resistance, therefore decreasing the need for contrast to be diverted

Interventions

DEVICEDyeVert System

The DyeVert System (Osprey Medical, Inc) consists of a Contrast Monitoring Wireless Display (CMW) and the DyeVert Plus Disposable Kit which is inclusive of a disposable single-use sterile Smart Syringe and DyeVert Plus Module.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Subjects undergoing CTO PCI at each of the participating centers. 2. Contrast volume recorded during CTO PCI 3. Subjects included in the Multicenter Registry of Chronic Total Occlusion Interventions study (Allina IRB approval # 948134-1)

Exclusion criteria

None

Design outcomes

Primary

Measure	Time frame	Description
Contrast volume administration during CTO PCI	During the CTO PCI procedure	The hypothesis of the study is that use of the DyeVert System will result in lower contrast volume, determined through real-time monitoring with the DyeVert System.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026