Radiographic Contrast Agent NephropathyNCT01168024
Contrast Media Reduction and Removal in Patients With Chronic Kidney Disease (CKD) (PRESERV)
A study testing CINCOR™ System and contrast conservation unit (CCS-1) in people with Radiographic Contrast Agent Nephropathy, run by Osprey Medical, Inc at 21 sites in 2 countries.
Trial summary
The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey Medical CINCOR™ Contrast Removal System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiographic Contrast Agent Nephropathy
- What is being tested?
- CINCOR™ System and contrast conservation unit (CCS-1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Dec 2012to Nov 2013
- 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 at least 18 years of age.
- The subject is a candidate for a therapeutic coronary PCI procedure of the left coronary artery and/or its branches or a combination procedure including left coronary artery/branches AND right coronary artery that is expected to utilize at least 50 mL of iodinated contrast media.
- The subject has baseline eGFR between 20 and 30 mL/min/1.73 m2 inclusive (as determined by the MDRD equation (Levey 1993)); or patient has eGFR above 30 but less than or equal to 60 with at least two of the following: stage III/IV NYHA congestive heart failure, diabetes mellitus, hypertension, age of at least 75 years.
- The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.
- The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
Who cannot join
- The subject has unstable renal function (acute renal failure or change in serum creatinine of > 0.5mg/dL or > 25% within 7 days of the procedure not attributed to hydration therapy).
- The subject requires dialysis.
- The subject has received contrast media within 7 days of the procedure.
- The subject will receive > 10 ml of iodinated contrast media in any location other than the coronary arteries (e.g. ventriculography, aortography, renal angiography) during the procedure or within a period of 30 days after the procedure.
- The subject requires one or more of the following nephrotoxic agents: Aminoglycoside antibiotics, Sulfonamides, Amphotericin B, Levofloxacin, Ciprofloxacin, Rifampin, Tetracycline, Intravenous Acyclovir, Pentamidine, Penicillin and Cephalosporins, Cisplatin, Methotrexate, Mitomycin, Cyclosporine, Tacrolimus.
- The subject has hemoglobin (Hb) < 9.5 g/dL within one (1) week of the procedure.
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- The subject is hemodynamically unstable or requires hemodynamic support including intra-venous inotropes, vasopressors, or any type of ventricular assist devices (including intra-aortic balloon pumps, the Impella cardiac assist device, the TandemHeart VAD, and surgically implanted ventricular assist devices).
- The subject has had acute myocardial infarction within last 24 hours (as defined in the "Universal Definition of Myocardial Infarction (Thygesen 2007) or has biomarkers of cardiac injury that have not stabilized. (Patients with MI within 96 hours of index procedure must demonstrate falling biomarkers of cardiac injury).
- The subject has any of the following procedural contra-indications
- has a left heart pacing lead or other implant indwelling in the coronary sinus or has had an artificial valve or pacemaker lead implanted in the right heart within 8 weeks of the planned procedure
- has a known bleeding diathesis (e.g. thrombocytopenia [<100,000 cells/mm3], heparin-induced thrombocytopenia, hemophilia, or von Willebrand disease, any history of intracranial bleeding, or gastrointestinal or gross genitourinary bleeding)
- The subject is currently on intravenous anti-coagulation that cannot be discontinued prior to the procedure
- The subject has a known hypersensitivity to both heparin and bivalirudin or aspirin or all thienopyridine agents or iodinated contrast that cannot be adequately pre-medicated
- The subject has an active systemic infection
- The subject refuses to accept blood products (e.g. Jehovah's Witness)
- The subject is known to be or suspected to be pregnant, or is lactating (all women of child-bearing potential must have a negative pregnancy test within 72 hours before participating in this protocol).
- The subject is currently participating in another investigational device or drug study that has not reached its primary endpoint.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
Charleston Area Medical Center
Charleston, West Virginia, 25304
The Heart and Vascular Institute of Florida
Clearwater, Florida, 33753
South Carolina Heart Center
Columbia, South Carolina, 29204
St. Mary's Medical Center
Duluth, Minnesota, 55805
Elyria Memorial Hospital Medical Center
Elyria, Ohio, 44035
Greenville Health System
Greenville, South Carolina, 29605
Infinity Clinical Research
Hollywood, Florida, 33021
The Methodist Hospital of Research
Houston, Texas, 77030
Heart Care Research, LLC
Huntsville, Alabama, 35801
Franciscan St. Francis Health
Indianapolis, Indiana, 46237
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Kaiser Permanente
Los Angeles, California, 90027
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, 73120
St. Luke's Medical Center
Phoenix, Arizona, 85006
Stanford Hospitals and Clinics
Stanford, California, 94305
Harbor UCLA
Torrance, California, 90502
Cardiovascular Associates of East Texas, PA
Tyler, Texas, 75701
York Hospital
York, Pennsylvania, 17405
About this study
Official title: PRESERV (Prospective Randomized Evaluation to Study the Effects of Reduced Contrast Media on the Vitality of the Kidney) Pivotal Trial
The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey Medical CINCOR™ Contrast Removal System.
Read the detailed description
The CINCOR™ Catheter System to retrieve contrast media from the coronary sinus following injection during percutaneous coronary interventions.
- Conditions
- Radiographic Contrast Agent Nephropathy
- Being tested
- CINCOR™ System and contrast conservation unit (CCS-1), Standard of Care plus peri-procedural hydration
- Keywords
- Acute Kidney Injury, Iodinated Contrast Agent Retrieval, Coronary Sinus Cannulation
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CINCOR™ System and contrast conservation unit (CCS-1)Device
Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media
Standard of Care plus peri-procedural hydrationOther
The control group will receive a peri and post-procedural hydration rate.
| Study group | Role | What they receive |
|---|---|---|
| CINCOR™ System Treatment | Experimental | Use of the CINCOR™ System and CCS-1 device during the pericutanous coronary intervention (PCI) procedure plus Standard of Care peri-procedural hydration for the prevention of contrast induced nephropathy (CIN). Receives: Device: CINCOR™ System and contrast conservation unit (CCS-1); Other: Standard of Care plus peri-procedural hydration |
| Standard of Care | Other | The control group will receive a peri and post-procedural hydration rate. Receives: Other: Standard of Care plus peri-procedural hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Contrast Induced Nephropathy (CIN) in Subjects.
CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL).
Measured: Through 72 hours post-procedure
Evaluating Bleeding/Transfusion Events.
Bleeding/transfusion events evaluated:
- Blood loss requiring transfusion of ≥ 2 units
- Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
- TIMI Minor Bleeding
Measured: Through 30 days post-procedure
Evaluating Local Events.
Events evaluated include:
- Coronary sinus perforation, dissection, or occlusion that requires treatment or results in MI or death
- Pericardial effusions (including pericardial tamponade) requiring treatment
Measured: Through 30 days post-procedure.
Secondary outcomes (1)
Change in Kidney Function Between the Randomized Groups.
Measured: Up to 96 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startDec 2012
- Primary completionOct 2013
- Study completionNov 2013
Why it stopped: Study closed by sponsor prior to completing enrollment goal.
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.
- Other trials for Radiographic Contrast Agent NephropathyStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osprey Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg Stone, MD, Principal investigator, CRF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168024
- Sponsor's protocol ID
- TP-6142
- Status last verified
- Oct 2016
- First submitted
- 20 Jul 2010
- Last updated
- 12 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESERV (Prospective Randomized Evaluation to Study the Effects of Reduced Contrast Media on the Vitality of the Kidney) Pivotal Trial
- ClinicalTrials.gov ID
- NCT01168024
- Acronym / sponsor ID
- TP-6142
- Conditions
- Radiographic Contrast Agent Nephropathy
- Keywords
- Acute Kidney Injury, Iodinated Contrast Agent Retrieval, Coronary Sinus Cannulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed by sponsor prior to completing enrollment goal.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Osprey Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Posted 12 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey Medical CINCOR™ Contrast Removal System.
Detailed description
The CINCOR™ Catheter System to retrieve contrast media from the coronary sinus following injection during percutaneous coronary interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CINCOR™ System Treatment | Experimental | Device: CINCOR™ System and contrast conservation unit (CCS-1), Other: Standard of Care plus peri-procedural hydrationUse of the CINCOR™ System and CCS-1 device during the pericutanous coronary intervention (PCI) procedure plus Standard of Care peri-procedural hydration for the prevention of contrast induced nephropathy (CIN). |
| Standard of Care | Other | Other: Standard of Care plus peri-procedural hydrationThe control group will receive a peri and post-procedural hydration rate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is at least 18 years of age.
- The subject is a candidate for a therapeutic coronary PCI procedure of the left coronary artery and/or its branches or a combination procedure including left coronary artery/branches AND right coronary artery that is expected to utilize at least 50 mL of iodinated contrast media.
- The subject has baseline eGFR between 20 and 30 mL/min/1.73 m2 inclusive (as determined by the MDRD equation (Levey 1993)); or patient has eGFR above 30 but less than or equal to 60 with at least two of the following: stage III/IV NYHA congestive heart failure, diabetes mellitus, hypertension, age of at least 75 years.
- The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.
- The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
Key exclusion criteria (17 listed)
- The subject has unstable renal function (acute renal failure or change in serum creatinine of > 0.5mg/dL or > 25% within 7 days of the procedure not attributed to hydration therapy).
- The subject requires dialysis.
- The subject has received contrast media within 7 days of the procedure.
- The subject will receive > 10 ml of iodinated contrast media in any location other than the coronary arteries (e.g. ventriculography, aortography, renal angiography) during the procedure or within a period of 30 days after the procedure.
- The subject requires one or more of the following nephrotoxic agents: Aminoglycoside antibiotics, Sulfonamides, Amphotericin B, Levofloxacin, Ciprofloxacin, Rifampin, Tetracycline, Intravenous Acyclovir, Pentamidine, Penicillin and Cephalosporins, Cisplatin, Methotrexate, Mitomycin, Cyclosporine, Tacrolimus.
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 |
|---|---|---|
| CINCOR™ System and contrast conservation unit (CCS-1)Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media | Device | CINCOR™ System Treatment |
| Standard of Care plus peri-procedural hydrationThe control group will receive a peri and post-procedural hydration rate. | Other | CINCOR™ System Treatment, Standard of Care |
Primary outcome
Incidence of Contrast Induced Nephropathy (CIN) in Subjects.
Time frame: Through 72 hours post-procedure
CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL).
Evaluating Bleeding/Transfusion Events.
Time frame: Through 30 days post-procedure
Bleeding/transfusion events evaluated: * Blood loss requiring transfusion of ≥ 2 units * Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding * TIMI Minor Bleeding
Evaluating Local Events.
Time frame: Through 30 days post-procedure.
Events evaluated include: * Coronary sinus perforation, dissection, or occlusion that requires treatment or results in MI or death * Pericardial effusions (including pericardial tamponade) requiring treatment
1 secondary outcome
Change in Kidney Function Between the Randomized Groups.
Time frame: Up to 96 hours post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Gregg Stone, MD principal investigator
CRF
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CINCOR™ System and contrast conservation unit (CCS-1) in people with Radiographic Contrast Agent Nephropathy, run by Osprey Medical, Inc at 21 sites in 2 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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany. 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 12 Dec 2016). 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?
Incidence of Contrast Induced Nephropathy (CIN) in Subjects. (time frame: Through 72 hours post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2016.