Contrast Media Reduction and Removal in Patients With Chronic Kidney Disease (CKD) (PRESERV)
NCT ID: NCT01168024
Last Updated: 2016-12-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
16 participants
INTERVENTIONAL
2012-12-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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CINCOR™ System Treatment
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).
CINCOR™ System and contrast conservation unit (CCS-1)
Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media
Standard of Care plus peri-procedural hydration
The control group will receive a peri and post-procedural hydration rate.
Standard of Care
The control group will receive a peri and post-procedural hydration rate.
Standard of Care plus peri-procedural hydration
The control group will receive a peri and post-procedural hydration rate.
Interventions
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CINCOR™ System and contrast conservation unit (CCS-1)
Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media
Standard of Care plus peri-procedural hydration
The control group will receive a peri and post-procedural hydration rate.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.
5. The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
Exclusion Criteria
2. The subject requires dialysis.
3. The subject has received contrast media within 7 days of the procedure.
4. 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.
5. 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.
6. The subject has hemoglobin (Hb) \< 9.5 g/dL within one (1) week of the procedure.
7. 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).
8. 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).
9. The subject has any of the following procedural contra-indications
1. 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
2. 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)
3. The subject is currently on intravenous anti-coagulation that cannot be discontinued prior to the procedure
4. 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
5. The subject has an active systemic infection
6. The subject refuses to accept blood products (e.g. Jehovah's Witness)
10. 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).
11. The subject is currently participating in another investigational device or drug study that has not reached its primary endpoint.
18 Years
ALL
No
Sponsors
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Osprey Medical, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Gregg Stone, MD
Role: PRINCIPAL_INVESTIGATOR
CRF
Locations
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Heart Care Research, LLC
Huntsville, Alabama, United States
St. Luke's Medical Center
Phoenix, Arizona, United States
Kaiser Permanente
Los Angeles, California, United States
Stanford Hospitals and Clinics
Stanford, California, United States
Harbor UCLA
Torrance, California, United States
The Heart and Vascular Institute of Florida
Clearwater, Florida, United States
Infinity Clinical Research
Hollywood, Florida, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
St. Mary's Medical Center
Duluth, Minnesota, United States
Elyria Memorial Hospital Medical Center
Elyria, Ohio, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States
York Hospital
York, Pennsylvania, United States
South Carolina Heart Center
Columbia, South Carolina, United States
Greenville Health System
Greenville, South Carolina, United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, United States
The Methodist Hospital of Research
Houston, Texas, United States
Cardiovascular Associates of East Texas, PA
Tyler, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Cardiology Center Leipzig Ltd.
Leipzig, Saxony, Germany
Countries
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Other Identifiers
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TP-6142
Identifier Type: -
Identifier Source: org_study_id