REduction of Contrast Via DyeVert Used in CTO Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-26

Study Completion Date

2018-02-02

Brief Summary

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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)

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Detailed Description

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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

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Chronic Total Occlusion of Coronary Artery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

DyeVert System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)