CompletedNot Applicable

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

United States, Australia, New Zealand578 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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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