N/A
Completed N=578
AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN
Contrast Induced Nephropathy (CIN)
Source: ClinicalTrials.gov NCT01976299 ↗
Enrolled (actual)
578
Serious AEs
12.8%
Results posted
Jan 2017
Primary outcomePrimary: Primary Effectiveness Endpoint — 76; 75 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint |
76; 75 | — |
| PRIMARY Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event |
1 | — |
| SECONDARY Secondary Endpoint 1- |
87; 102.4 | — |
| SECONDARY Secondary Endpoint 2- Comparison of Serious Adverse Events. |
43; 46 | — |
| SECONDARY Secondary Endpoint 3- Change in Kidney Function. |
6.3; 5.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01976299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.