Contrast Media Reduction and Removal in Patients With Chronic Kidney Disease (CKD) (PRESERV)

Not Applicable

Terminated

Conditions: Radiographic Contrast Agent Nephropathy

Interventions: Device: CINCOR™ System and contrast conservation unit (CCS-1)
Other: Standard of Care plus peri-procedural hydration

Registration Number: NCT01168024

Lead Sponsor: Osprey Medical, Inc

Brief Summary: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 16

Inclusion Criteria

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.

Exclusion Criteria

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.
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
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)
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CINCOR™ System Treatment	Standard of Care plus peri-procedural hydration	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).
Standard of Care	Standard of Care plus peri-procedural hydration	The control group will receive a peri and post-procedural hydration rate.
CINCOR™ System Treatment	CINCOR™ System and contrast conservation unit (CCS-1)	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).

Primary Outcome Measures

Name	Time	Method
Evaluating Local Events.	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
Incidence of Contrast Induced Nephropathy (CIN) in Subjects.	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.	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

Secondary Outcome Measures

Name	Time	Method
Change in Kidney Function Between the Randomized Groups.	Up to 96 hours post-procedure

Trial Locations

Locations (21): Saint Joseph's Hospital of Atlanta
🇺🇸
Atlanta, Georgia, United States
The Methodist Hospital of Research
🇺🇸
Houston, Texas, United States
Franciscan St. Francis Health
🇺🇸
Indianapolis, Indiana, United States
York Hospital
🇺🇸
York, Pennsylvania, United States
Heart Care Research, LLC
🇺🇸
Huntsville, Alabama, United States
St. Mary's Medical Center
🇺🇸
Duluth, Minnesota, United States
Tennova Healthcare - Turkey Creek Medical Center
🇺🇸
Knoxville, Tennessee, United States
Charleston Area Medical Center
🇺🇸
Charleston, West Virginia, United States
Greenville Health System
🇺🇸
Greenville, South Carolina, United States
St. Luke's Medical Center
🇺🇸
Phoenix, Arizona, United States
Cardiology Center Leipzig Ltd.
🇩🇪
Leipzig, Saxony, Germany
The Heart and Vascular Institute of Florida
🇺🇸
Clearwater, Florida, United States
South Carolina Heart Center
🇺🇸
Columbia, South Carolina, United States
Kaiser Permanente
🇺🇸
Los Angeles, California, United States
Stanford Hospitals and Clinics
🇺🇸
Stanford, California, United States
Harbor UCLA
🇺🇸
Torrance, California, United States
Infinity Clinical Research
🇺🇸
Hollywood, Florida, United States
Elyria Memorial Hospital Medical Center
🇺🇸
Elyria, Ohio, United States
Oklahoma Foundation for Cardiovascular Research
🇺🇸
Oklahoma City, Oklahoma, United States
Cardiovascular Associates of East Texas, PA
🇺🇸
Tyler, Texas, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States