An interventional study of AVERT in Contrast Induced Nephropathy (CIN), sponsored by Osprey Medical, Inc. Completed at 39 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by Osprey Medical, Inc · Not applicable, Interventional, and Prevention
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).
The purpose of this trial is to assess the AVERT System device, which is designed to limit the volume of CM (Contrast Media) utilized, during a staged therapeutic coronary PCI (Percutaneous Coronary Intervention) or a coronary diagnostic procedure that is anticipated to become a PCI (i.e. ad hoc PCI) for the reduction of CIN (Contrast Induced Nephropathy).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 578 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Osprey Medical, Inc is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard of Care with the AVERT system
Device: AVERT
Primary Effectiveness Endpoint
Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.
Time frame: 3-5 days
Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event
Analyze the incidence of device related serious adverse events within the treatment arm.
Time frame: 30 days
Secondary Endpoint 1-
Comparison in contrast media volume required between active treament and standard of care.
Time frame: 30 Days
Secondary Endpoint 2- Comparison of Serious Adverse Events.
Comparing event rates of serious adverse events 30 days following the index procedure.
Time frame: 30 Days
Secondary Endpoint 3- Change in Kidney Function.
Change in kidney function by analyzing eGFR 3 to 5 days post procedure.
Time frame: 3-5 days
| Milestone | Active Treatment | Standard of Care |
|---|---|---|
| Started | 292 | 286 |
| Completed procedure | 283 | 284 |
| Completed | 269 | 280 |
| Not completed | 23 | 6 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Death | 4 | 2 |
| Withdrew: Lost to follow-up | 7 | 1 |
| Withdrew: See clarification above in comments | 9 | 2 |
Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.
| Participants | Active Treatment | Standard of Care |
|---|---|---|
| Primary Effectiveness Endpoint | 76 | 75 |
Analyze the incidence of device related serious adverse events within the treatment arm.
| Participants | Active Treatment | Standard of Care |
|---|---|---|
| Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event | 1 | — |
Comparison in contrast media volume required between active treament and standard of care.
| Contrast Volume (ml) | Active Treatment | Standard of Care |
|---|---|---|
| Secondary Endpoint 1- | 87 ± 52.4 | 102.4 ± 74.1 |
Comparing event rates of serious adverse events 30 days following the index procedure.
| events | Active Treatment | Standard of Care |
|---|---|---|
| Secondary Endpoint 2- Comparison of Serious Adverse Events. | 43 | 46 |
Change in kidney function by analyzing eGFR 3 to 5 days post procedure.
| mL/min/1.73m² | Active Treatment | Standard of Care |
|---|---|---|
| Secondary Endpoint 3- Change in Kidney Function. | 6.3 ± 8.1 | 5.9 ± 7.5 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Treatment | — | 36/292 (12.3%) | 0/292 (0%) |
| Standard of Care | — | 38/286 (13.3%) | 0/286 (0%) |
| Event | Active Treatment | Standard of Care |
|---|---|---|
| Unplanned re-hospitalizationGeneral disorders | 26/292 | 23/286 |
| Myocardial InfarctionCardiac disorders | 4/292 | 7/286 |
| Revascularization of target lesionCardiac disorders | 4/292 | 6/286 |
| Major bleedingSurgical and medical procedures | 6/292 | 4/286 |
| All-Cause MortalityGeneral disorders | 5/292 | 3/286 |
| Dialysis dependent CINRenal and urinary disorders | 3/292 | 1/286 |
| StrokeCardiac disorders | 1/292 | 0/286 |
| Age, Continuous(years) | Active Treatment | Standard of Care | Total |
|---|---|---|---|
| Mean | 71 ± 9.3 | 72.3 ± 9.4 | 71.6 ± 9.4 |
| Gender(Participants) | Active Treatment | Standard of Care | Total |
|---|---|---|---|
| Female | 114 | 113 | 227 |
| Male | 178 | 173 | 351 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Osprey Medical, Inc