Trial Outcomes & Findings for AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN (NCT NCT01976299)

Results Overview

Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

578 participants

Primary outcome timeframe

3-5 days

Results posted on

2017-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Active Treatment Standard of Care with the AVERT system AVERT	Standard of Care
Overall Study STARTED	292	286
Overall Study Completed Procedure	283	284
Overall Study COMPLETED	269	280
Overall Study NOT COMPLETED	23	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Treatment Standard of Care with the AVERT system AVERT	Standard of Care
Overall Study Withdrawal by Subject	3	1
Overall Study Death	4	2
Overall Study Lost to Follow-up	7	1
Overall Study See clarification above in comments	9	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment n=292 Participants Standard of Care with the AVERT system AVERT	Standard of Care n=286 Participants	Total n=578 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 9.3 • n=5 Participants	72.3 years STANDARD_DEVIATION 9.4 • n=7 Participants	71.6 years STANDARD_DEVIATION 9.4 • n=5 Participants
Gender Female	114 Participants n=5 Participants	113 Participants n=7 Participants	227 Participants n=5 Participants
Gender Male	178 Participants n=5 Participants	173 Participants n=7 Participants	351 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3-5 days

Population: Only subjects that completed blood draws were analyzed for this outcome.

Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.

Outcome measures

Outcome measures
Measure	Active Treatment n=281 Participants Standard of Care with the AVERT system AVERT	Standard of Care n=282 Participants
Primary Effectiveness Endpoint	76 Participants	75 Participants

PRIMARY outcome

Timeframe: 30 days

Analyze the incidence of device related serious adverse events within the treatment arm.

Outcome measures

Outcome measures
Measure	Active Treatment n=292 Participants Standard of Care with the AVERT system AVERT	Standard of Care
Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event	1 Participants	—

SECONDARY outcome

Timeframe: 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.

Comparison in contrast media volume required between active treament and standard of care.

Outcome measures

Outcome measures
Measure	Active Treatment n=147 Participants Standard of Care with the AVERT system AVERT	Standard of Care n=137 Participants
Secondary Endpoint 1-	87 Contrast Volume (ml) Standard Deviation 52.4	102.4 Contrast Volume (ml) Standard Deviation 74.1

SECONDARY outcome

Timeframe: 30 Days

Comparing event rates of serious adverse events 30 days following the index procedure.

Outcome measures

Outcome measures
Measure	Active Treatment n=292 Participants Standard of Care with the AVERT system AVERT	Standard of Care n=286 Participants
Secondary Endpoint 2- Comparison of Serious Adverse Events.	43 events	46 events

SECONDARY outcome

Timeframe: 3-5 days

Change in kidney function by analyzing eGFR 3 to 5 days post procedure.

Outcome measures

Outcome measures
Measure	Active Treatment n=281 Participants Standard of Care with the AVERT system AVERT	Standard of Care n=282 Participants
Secondary Endpoint 3- Change in Kidney Function.	6.3 mL/min/1.73m² Standard Deviation 8.1	5.9 mL/min/1.73m² Standard Deviation 7.5

Adverse Events

Active Treatment

Serious events: 36 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 38 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Treatment n=292 participants at risk Standard of Care with the AVERT system AVERT	Standard of Care n=286 participants at risk
Cardiac disorders Myocardial Infarction	1.4% 4/292 • Number of events 4 • 30 days	2.4% 7/286 • Number of events 7 • 30 days
Renal and urinary disorders Dialysis dependent CIN	1.0% 3/292 • Number of events 3 • 30 days	0.35% 1/286 • Number of events 1 • 30 days
General disorders Unplanned re-hospitalization	8.9% 26/292 • Number of events 28 • 30 days	8.0% 23/286 • Number of events 23 • 30 days
Surgical and medical procedures Major bleeding	2.1% 6/292 • Number of events 6 • 30 days	1.4% 4/286 • Number of events 5 • 30 days
Cardiac disorders Stroke	0.34% 1/292 • Number of events 1 • 30 days	0.00% 0/286 • 30 days
General disorders All-Cause Mortality	1.7% 5/292 • Number of events 5 • 30 days	1.0% 3/286 • Number of events 3 • 30 days
Cardiac disorders Revascularization of target lesion	1.4% 4/292 • Number of events 4 • 30 days	2.1% 6/286 • Number of events 6 • 30 days

Other adverse events

Adverse event data not reported

Additional Information

Michele Shepard, Vice President of Clinical Affairs

Osprey Medical, Inc

Phone: 9529558236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place