DyeVert Pilot Trial

Not Applicable

Completed

• Conditions: Coronary Angiography
• Interventions: Device: 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

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Coronary Angiography	All subjects enrolled in the trial will use the DyeVert System.

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)

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

Monash Health; 🇦🇺 Clayton, Victoria, Australia