AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN (AVERT™)
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|ClinicalTrials.gov Identifier: NCT01976299|
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : January 2, 2017
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Contrast Induced Nephropathy (CIN)||Device: AVERT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||578 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||AVERT™ Clinical Trial|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Active Treatment
Standard of Care with the AVERT system
|No Intervention: Standard of Care|
- Primary Effectiveness Endpoint [ Time Frame: 3-5 days ]Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.
- Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event [ Time Frame: 30 days ]Analyze the incidence of device related serious adverse events within the treatment arm.
- Secondary Endpoint 1- [ Time Frame: 30 Days ]Comparison in contrast media volume required between active treament and standard of care.
- Secondary Endpoint 2- Comparison of Serious Adverse Events. [ Time Frame: 30 Days ]Comparing event rates of serious adverse events 30 days following the index procedure.
- Secondary Endpoint 3- Change in Kidney Function. [ Time Frame: 3-5 days ]Change in kidney function by analyzing eGFR 3 to 5 days post procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976299
|Principal Investigator:||Roxana Mehran, MD, FACC||Icahn School of Medicine at Mount Sinai|