REduction of Contrast Via DyeVert Used in CTO Procedures

Chronic Total Occlusion of Coronary Artery Clinical Trial

— REDUCe  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03118544
• Other study ID #: MinneapolisHIF
• Status: Terminated
• Start date: March 26, 2017
• Est. completion date: February 2, 2018

Study information

• Verified date: May 2018
• Source: Minneapolis Heart Institute Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: February 2, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery

Intervention

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.

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation	Osprey Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast volume administration during CTO PCI	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.	During the CTO PCI procedure