DyeVert Pilot Trial

Not Applicable

Completed

• Conditions: Coronary Angiography

• Registration Number: NCT02606734
• Lead Sponsor: Osprey Medical, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-11-13
• Study First Posted: 2015-11-17
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2016-05-18
• Results First Submitted QC: 2016-06-27
• Results First Posted: 2016-08-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure	1 Day	The subject is exited from the study once they are discharged.

Trial Locations

Locations (2)

Monash Health; 🇦🇺 Clayton, Victoria, Australia

University Hospital of Schleswig-Holstein; 🇩🇪 Lübeck, Germany