N/A
Completed N=96
DyeVert System RCT
Source: ClinicalTrials.gov NCT02752802 ↗Enrolled (actual)
96
Serious AEs
6.3%
Results posted
Feb 2017
Primary outcomePrimary: Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group. — 38.0; 62.5 ml
Summary
The purpose of this study is to evaluate the amount of contrast media (CM) saved using the DyeVert system in diagnostic angiographic procedures compared to a control group.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group. |
38.0; 62.5 | — |
| SECONDARY Assessment of the Quality of Angiographic Images Between Groups |
379; 386 | — |
| SECONDARY Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure. |
— | — |
Eligibility Criteria
Inclusion Criteria
- The subject is indicated for a diagnostic coronary angiogram procedure with a 5 French catheter only.
- The subject is ≥ 18 years of age
- The subject is willing and able to provide appropriate informed consent.
Exclusion Criteria
- Subject is undergoing a STEMI procedure
- Subject has previously been diagnosed with anomalous coronary anatomy
- Subject has previously underwent coronary artery bypass grafting
- Subject has severe peripheral artery disease at access site
- Subject is having a staged PCI
- 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 (NCT02752802). 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.