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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
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
1/12/2013
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
The Osprey Medical AVERT System is indicated to reduce contrast media (CM) exposure to the kidneys during percutaneous coronary procedures thereby reducing the risk of contrast induced nephropathy (CIN).
Trial website
https://clinicaltrials.gov/study/NCT01976299
Trial related presentations / publications
Mehran R, Faggioni M, Chandrasekhar J, Angiolillo DJ, Bertolet B, Jobe RL, Al-Joundi B, Brar S, Dangas G, Batchelor W, Prasad A, Gurm HS, Tumlin J, Stone GW. Effect of a Contrast Modulation System on Contrast Media Use and the Rate of Acute Kidney Injury After Coronary Angiography. JACC Cardiovasc Interv. 2018 Aug 27;11(16):1601-1610. doi: 10.1016/j.jcin.2018.04.007.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01976299