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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
Sponsor:
Information provided by (Responsible Party):
Osprey Medical, Inc

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).

Condition or disease Intervention/treatment Phase
Contrast Induced Nephropathy (CIN) Device: AVERT Not Applicable

Detailed Description:
The purpose of this trial is to assess the AVERT System device, which is designed to limit the volume of CM (Contrast Media) utilized, during a staged therapeutic coronary PCI (Percutaneous Coronary Intervention) or a coronary diagnostic procedure that is anticipated to become a PCI (i.e. ad hoc PCI) for the reduction of CIN (Contrast Induced Nephropathy).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 578 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: AVERT™ Clinical Trial
Study Start Date : December 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Experimental: Active Treatment
Standard of Care with the AVERT system
Device: AVERT
No Intervention: Standard of Care



Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Secondary Endpoint 1- [ Time Frame: 30 Days ]
    Comparison in contrast media volume required between active treament and standard of care.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
  • The subject has documented chronic kidney disease (CKD)

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.

Information from the National Library of Medicine

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


Locations
Show Show 39 study locations
Sponsors and Collaborators
Osprey Medical, Inc
Investigators
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Principal Investigator: Roxana Mehran, MD, FACC Icahn School of Medicine at Mount Sinai
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Osprey Medical, Inc
ClinicalTrials.gov Identifier: NCT01976299    
Other Study ID Numbers: TP-6364
First Posted: November 5, 2013    Key Record Dates
Results First Posted: January 2, 2017
Last Update Posted: February 28, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases