An observational study in Chronic Total Occlusion of Coronary Artery, sponsored by Minneapolis Heart Institute Foundation. Terminated at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-17.
Sponsored by Minneapolis Heart Institute Foundation · Observational
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)
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
Minneapolis Heart Institute Foundation is the lead sponsor of 33 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing clinically-indicated chronic total occlusion (CTO) percutaneous coronary intervention (PCI)
Exclusion Criteria:
None
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.
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.
Time frame: During the CTO PCI procedure
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Minneapolis Heart Institute Foundation