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

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-003881
    NCT ID: NCT01976299
    Sponsor Protocol Number: TP-6364

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Patricia Best, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20145191

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