Contrast Induced Nephropathy (CIN)
Conditions
Brief 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).
Detailed description
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).
Interventions
DEVICEAVERT
Sponsors
Osprey Medical, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | 3-5 days | Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days. |
| Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event | 30 days | Analyze the incidence of device related serious adverse events within the treatment arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint 3- Change in Kidney Function. | 3-5 days | Change in kidney function by analyzing eGFR 3 to 5 days post procedure. |
| Secondary Endpoint 1- | 30 Days | Comparison in contrast media volume required between active treament and standard of care. |
| Secondary Endpoint 2- Comparison of Serious Adverse Events. | 30 Days | Comparing event rates of serious adverse events 30 days following the index procedure. |
Countries
Australia, New Zealand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment Standard of Care with the AVERT system
AVERT | 292 |
| Standard of Care | 286 |
| Total | 578 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 2 |
| Overall Study | Lost to Follow-up | 7 | 1 |
| Overall Study | See clarification above in comments | 9 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Active Treatment | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 9.3 | 72.3 years STANDARD_DEVIATION 9.4 | 71.6 years STANDARD_DEVIATION 9.4 |
| Gender Female | 114 Participants | 113 Participants | 227 Participants |
| Gender Male | 178 Participants | 173 Participants | 351 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 292 | 0 / 286 |
| serious Total, serious adverse events | 36 / 292 | 38 / 286 |
Outcome results
Primary
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
Population: Only subjects that completed blood draws were analyzed for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment | Primary Effectiveness Endpoint | 76 Participants |
| Standard of Care | Primary Effectiveness Endpoint | 75 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment | Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event | 1 Participants |
Secondary
Secondary Endpoint 1-
Comparison in contrast media volume required between active treament and standard of care.
Time frame: 30 Days
Population: Reduction in volume of contrast was analysed in an interim analysis once half the patient population was enrolled. Additionally, only subjects that completed the procedure were analyzed for this endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Secondary Endpoint 1- | 87 Contrast Volume (ml) | Standard Deviation 52.4 |
| Standard of Care | Secondary Endpoint 1- | 102.4 Contrast Volume (ml) | Standard Deviation 74.1 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active Treatment | Secondary Endpoint 2- Comparison of Serious Adverse Events. | 43 events |
| Standard of Care | Secondary Endpoint 2- Comparison of Serious Adverse Events. | 46 events |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Treatment | Secondary Endpoint 3- Change in Kidney Function. | 6.3 mL/min/1.73m² | Standard Deviation 8.1 |
| Standard of Care | Secondary Endpoint 3- Change in Kidney Function. | 5.9 mL/min/1.73m² | Standard Deviation 7.5 |