NCT03118544

REduction of Contrast Via DyeVert Used in CTO Procedures

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Minneapolis Heart Institute Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Chronic Total Occlusion of Coronary Artery

Interventions

Type	Name	Description
DEVICE	DyeVert 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.

Timeline

• Start date: 2017-03-26
• Primary completion: 2018-02-02
• Completion: 2018-02-02
• First posted: 2017-04-18
• Last updated: 2018-05-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study