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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02606734




Registration number
NCT02606734
Ethics application status
Date submitted
28/10/2015
Date registered
17/11/2015
Date last updated
26/10/2016

Titles & IDs
Public title
DyeVert Pilot Trial
Scientific title
DyeVert Pilot Trial
Secondary ID [1] 0 0
TP-6463
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Angiography 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Coronary Angiography

Other: Treatment Arm - All subjects enrolled in the trial will use the DyeVert System.


Treatment: Devices: Coronary Angiography
The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure
Timepoint [1] 0 0
1 Day

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Lübeck

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Osprey Medical, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT02606734
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries