Contrast Induced Nephropathy (CIN)AVERT™NCT01976299
AVERT™ Clinical Trial for Contrast Media Volume Reduction and Incidence of CIN
A study testing AVERT in people with Contrast Induced Nephropathy (CIN), run by Osprey Medical, Inc at 39 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Induced Nephropathy (CIN)
- What is being tested?
- AVERT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 578 participants
- Where
- 39 sitesin 3 countries
- Study dates
- Dec 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
- The subject has documented chronic kidney disease (CKD)
Who cannot join
- 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.
Trial locations and contacts
39 sites in 3 countries.
39 sites in 3 countries
United States37 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
St. Joseph's Hospital (Emory)
Atlanta, Georgia, 30342
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
The Heart & Vascular Institute of Florida
Clearwater, Florida, 33756
Providence Cardiology LLC
Columbia, South Carolina, 29204
VA North Texas Health Care System
Dallas, Texas, 75216
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401
CHI St. Luke's Health / Baylor St. Luke's Medical Center
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
University of FL College of Medicine - Jacksonville
Jacksonville, Florida, 32209
St. Vincent's Ambulatory Care (dba St. Vincent's Cardiology)
Jacksonville, Florida, 32216
Saint Luke's Hospital
Kansas City, Missouri, 64111
UCSD Medical Center
La Jolla, California, 92037
Long Beach CA VA Hospital
Long Beach, California, 90812
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Jewish Hospital
Louisville, Kentucky, 40202
Norton Cardiovascular Associates
Louisville, Kentucky, 40205
Coliseum Medical Center
Macon, Georgia, 31217
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Minneapolis Heart Institute Foundation / Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Mount Sinai Hospital
New York, New York, 10029
Sentara Cardiovascular Research Institute / Norfolk General
Norfolk, Virginia, 23507
Oklahoma Heart
Oklahoma City, Oklahoma, 73120
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
The Heart Hospital Baylor Plano
Plano, Texas, 75093
NC Heart and Vascular Research
Raleigh, North Carolina, 27610
Mayo Clinic Hospital, St. Mary's Campus
Rochester, Minnesota, 55902
U of TX Health Science Center San Antonio (UTHSCSA)
San Antonio, Texas, 78229-3900
Gateway Cardiovascular Research Center, Inc.
St Louis, Missouri, 63128
Stanford Hospital and Clinics
Stanford, California, 94305-5218
Tallahassee Research Institute, Inc.
Tallahassee, Florida, 32308
Harbor UCLA Medical Center
Torrance, California, 90509
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Trinity Mother Frances/Cardiovascular Associates of East Texas PA
Tyler, Texas, 75701
York Hospital
York, Pennsylvania, 17405
About this study
Official title: AVERT™ Clinical Trial
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).
Read the 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).
- Conditions
- Contrast Induced Nephropathy (CIN)
- Being tested
- AVERT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVERTDevice
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Standard of Care with the AVERT system Receives: Device: AVERT |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.
Measured: 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.
Measured: 30 days
Secondary outcomes (3)
Secondary Endpoint 1-
Comparison in contrast media volume required between active treament and standard of care.
Measured: 30 Days
Secondary Endpoint 2- Comparison of Serious Adverse Events.
Comparing event rates of serious adverse events 30 days following the index procedure.
Measured: 30 Days
Secondary Endpoint 3- Change in Kidney Function.
Change in kidney function by analyzing eGFR 3 to 5 days post procedure.
Measured: 3-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast Induced Nephropathy (CIN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osprey Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roxana Mehran, MD, FACC, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976299
- Sponsor's protocol ID
- TP-6364
- Acronym
- AVERT™
- Status last verified
- Jan 2017
- First submitted
- 29 Oct 2013
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mehran R, Faggioni M, Chandrasekhar J, Angiolillo DJ, Bertolet B, Jobe RL, Al-Joundi B, Brar S, Dangas G, Batchelor W, Prasad A, Gurm HS, Tumlin J, Stone GW. Effect of a Contrast Modulation System on Contrast Media Use and the Rate of Acute Kidney Injury After Coronary Angiography. JACC Cardiovasc Interv. 2018 Aug 27;11(16):1601-1610. doi: 10.1016/j.jcin.2018.04.007.
PubMed 30139467
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVERT™ Clinical Trial
- ClinicalTrials.gov ID
- NCT01976299
- Acronym / sponsor ID
- AVERT™ / TP-6364
- Conditions
- Contrast Induced Nephropathy (CIN)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Osprey Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Nov 2013 (estimated)
- Results
- Posted 2 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Device: AVERTStandard of Care with the AVERT system |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
- The subject has documented chronic kidney disease (CKD)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVERT | Device | Active Treatment |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 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
Time frame: 30 days
Analyze the incidence of device related serious adverse events within the treatment arm.
3 secondary outcomes
Secondary Endpoint 1-
Time frame: 30 Days
Secondary Endpoint 2- Comparison of Serious Adverse Events.
Time frame: 30 Days
Secondary Endpoint 3- Change in Kidney Function.
Time frame: 3-5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30139467Mehran R, Faggioni M, Chandrasekhar J, Angiolillo DJ, Bertolet B, Jobe RL, Al-Joundi B, Brar S, Dangas G, Batchelor W, Prasad A, Gurm HS, Tumlin J, Stone GW. Effect of a Contrast Modulation System on Contrast Media Use and the Rate of Acute Kidney Injury After Coronary Angiography. JACC Cardiovasc Interv. 2018 Aug 27;11(16):1601-1610. doi: 10.1016/j.jcin.2018.04.007.
Related trials for Contrast Induced Nephropathy (CIN)
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
Not yet recruitingEarly Phase 1
Role of Amlodipine in Reduction of CIN
Contrast-induced Nephropathy
Recruiting
Efficacy and Safety of a Beet-Derived Inorganic Nitrate-Based Food Product for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Percutaneous Coronary Intervention
Contrast-induced Nephropathy Following Percutaneous Intervention (CIN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roxana Mehran, MD, FACC principal investigator
Icahn School of Medicine at Mount Sinai
39 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVERT in people with Contrast Induced Nephropathy (CIN), run by Osprey Medical, Inc at 39 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 3-5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01976299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.