CompletedNot Applicable

AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN

United States578 participantsStarted 2013-12

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Primary Effectiveness Endpoint

Timeframe: 3-5 days

Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event

Timeframe: 30 days

Trial details

NCT IDNCT01976299

SponsorOsprey Medical, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-07

Results submitted2016-11-03

View on ClinicalTrials.gov More Contrast Induced Nephropathy (CIN) trials