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N/A N=96 Randomized Supportive Care

DyeVert System RCT

Coronary Angiography

Bottom Line

View on ClinicalTrials.gov: NCT02752802 ↗
Enrolled (actual)
96
Serious AEs
6.3%
Results posted
Feb 2017
Primary outcome: Primary: Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group. — 38.0; 62.5 ml

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Diagnostic Coronary Angiogram (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Osprey Medical, Inc
Primary completion
May 2016

Outcome Measures

OutcomeResultp-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.		 — —

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.

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
View full record on ClinicalTrials.gov →

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.

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