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Completed

NCT Number: NCT02606734

DyeVert Pilot Trial

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.

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Key information

Conditions

Coronary Angiography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monash Health, Clayton, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary Angiography

Device

The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.

Primary outcomes

  1. Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure

    Time frame: 1 Day

    The subject is exited from the study once they are discharged.

Sponsors and collaborators

Lead sponsor

Osprey Medical, Inc

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2015
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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