Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01976299




Registration number
NCT01976299
Ethics application status
Date submitted
29/10/2013
Date registered
5/11/2013
Date last updated
28/02/2017

Titles & IDs
Public title
AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN
Scientific title
AVERT™ Clinical Trial
Secondary ID [1] 0 0
TP-6364
Universal Trial Number (UTN)
Trial acronym
AVERT™
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contrast Induced Nephropathy (CIN) 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Active Treatment - Standard of Care with the AVERT system

No intervention: Standard of Care -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Effectiveness Endpoint
Timepoint [1] 0 0
3-5 days
Primary outcome [2] 0 0
Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
Secondary Endpoint 1-
Timepoint [1] 0 0
30 Days
Secondary outcome [2] 0 0
Secondary Endpoint 2- Comparison of Serious Adverse Events.
Timepoint [2] 0 0
30 Days
Secondary outcome [3] 0 0
Secondary Endpoint 3- Change in Kidney Function.
Timepoint [3] 0 0
3-5 days

Eligibility
Key inclusion criteria
* The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
* The subject has documented chronic kidney disease (CKD)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject is in acute renal failure
* Assessment of ventricular function that cannot be accomplished without the use of the CM.
* Subject has acute STEMI within 72 hours prior to planned PCI procedure, or is currently having an acute STEMI.
* Subject is unable to undergo peri-procedural hydration.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
NA
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
1/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
578
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Heart Center Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
New Zealand
State/province [18] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Roxana Mehran, MD, FACC
Address 0 0
Icahn School of Medicine at Mount Sinai
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01976299