N/A
Completed N=44
DyeVert Pilot Trial
Source: ClinicalTrials.gov NCT02606734 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure — 47.4 percent of contrast media saved
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure |
47.4 | — |
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
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. Informational only — not medical advice.