AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
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