N/A N=44 Treatment

DyeVert Pilot Trial

Coronary Angiography

Bottom Line

View on ClinicalTrials.gov: NCT02606734 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2016

Primary outcome: Primary: Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure — 47.4 percent of contrast media saved

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Coronary Angiography (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Osprey Medical, Inc
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure	47.4	—

Summary

The purpose of this study is to evaluate the usability characteristics of DyeVert™ during normal clinical use and to understand the amount of contrast media (CM) diverted from the subject and saved over a total angiographic procedure.

Eligibility Criteria

Inclusion Criteria

The subject is indicated for a coronary angiogram or percutaneous coronary procedure
The subject is ≥ 18 years of age
The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.

Exclusion Criteria

Subject is undergoing a STEMI procedure
The subject is female and currently pregnant
In the investigator's opinion, the subject is not considered to be a suitable candidate

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02606734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.