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

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

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)

Study Overview

• Status: Terminated
• Conditions: Chronic Total Occlusion of Coronary Artery
• Intervention / Treatment: Device: DyeVert System

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

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing CTO PCI; Evaluates the effect of the DyeVert System on contrast volume administration in patients undergoing clinically-indicated CTO PCI. The system allows monitoring and display of contrast volumes that are manually injected during the procedure which will be compared to physician entered contrast usage thresholds during angiographic procedures.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Minneapolis Heart Institute Foundation
• Collaborators: Osprey Medical, Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2017
• Primary Completion (Actual): February 2, 2018
• Study Completion (Actual): February 2, 2018

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: PCI; Coronary Artery Disease; Percutaneous Coronary Intervention; Chronic Total Occlusion; CTO
• Other Study ID Numbers: MinneapolisHIF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes