NCT02606734

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 8, 2016

Completed
Last Updated

October 26, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

October 28, 2015

Results QC Date

May 18, 2016

Last Update Submit

September 19, 2016

Conditions

Coronary Angiography

Outcome Measures

Primary Outcomes (1)

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

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

    1 Day

Study Arms (1)

Treatment Arm

OTHER

All subjects enrolled in the trial will use the DyeVert System.

Device: Coronary Angiography

Interventions

Coronary AngiographyDEVICE

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

Treatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Monash Health

Clayton, Victoria, 3168, Australia

Location

University Hospital of Schleswig-Holstein

Lübeck, 23538, Germany

Location

MeSH Terms

Interventions

Coronary Angiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularHeart Function Tests

Results Point of Contact

Title
Michele Shepard
Organization
Osprey Medical
mshepard@ospreymed.com
952-955-5236

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 17, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 26, 2016

Results First Posted

August 8, 2016

Record last verified: 2016-09

Locations

DE(1)AU(1)