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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118544
Recruitment Status : Terminated (Competing clinical trial priorities)
First Posted : April 18, 2017
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Osprey Medical, Inc
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation

Study Description
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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)

Condition or disease Intervention/treatment
Chronic Total Occlusion of Coronary Artery 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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: REduction of Contrast Via DyeVert Used in CTO Procedures (REDUCe)
Actual Study Start Date : March 26, 2017
Actual Primary Completion Date : February 2, 2018
Actual Study Completion Date : February 2, 2018
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Contrast volume administration during CTO PCI [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118544


Locations
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United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Osprey Medical, Inc
More Information
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Additional Information:

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Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT03118544    
Other Study ID Numbers: MinneapolisHIF
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Minneapolis Heart Institute Foundation:
Chronic Total Occlusion
Coronary Artery Disease
Percutaneous Coronary Intervention
CTO
PCI