DyeVert Pilot Trial

Coronary Angiography Clinical Trial

Official title:

DyeVert Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02606734
• Other study ID #: TP-6463
• Status: Completed
• Phase: N/A
• First received: October 28, 2015
• Last updated: May 2, 2016
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: Osprey Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Angiography

Intervention

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

Locations

Country	Name	City	State
Australia	Monash Health	Clayton	Victoria
Germany	University Hospital of Schleswig-Holstein	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
Osprey Medical, Inc

Countries where clinical trial is conducted

Australia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume (percentage) of CM diverted (saved) in a total procedure	The subject is exited from the study once they are discharged.	1 Day	No