Study Stopped
Competing clinical trial priorities
REduction of Contrast Via DyeVert Used in CTO Procedures
REDUCe
1 other identifier
observational
21
1 country
3
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2017
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 26, 2017
CompletedFirst Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2018
CompletedMay 17, 2018
May 1, 2018
10 months
April 13, 2017
May 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
You may qualify if:
- Subjects undergoing CTO PCI at each of the participating centers.
- Contrast volume recorded during CTO PCI
- Subjects included in the "Multicenter Registry of Chronic Total Occlusion Interventions" study (Allina IRB approval # 948134-1)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minneapolis Heart Institute Foundationlead
- Osprey Medical, Inccollaborator
Study Sites (3)
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2017
First Posted
April 18, 2017
Study Start
March 26, 2017
Primary Completion
February 2, 2018
Study Completion
February 2, 2018
Last Updated
May 17, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share