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

Study Overview
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Brief Summary
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The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey Medical CINCOR™ Contrast Removal System.

Detailed Description
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The CINCOR™ Catheter System to retrieve contrast media from the coronary sinus following injection during percutaneous coronary interventions.

Official Title
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PRESERV (Prospective Randomized Evaluation to Study the Effects of Reduced Contrast Media on the Vitality of the Kidney) Pivotal Trial

Conditions
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Radiographic Contrast Agent Nephropathy

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


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CINCOR™ System Treatment<br>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). | Device: CINCOR™ System and contrast conservation unit (CCS-1)<br>* Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media<br>Other: Standard of Care plus peri-procedural hydration<br>* The control group will receive a peri and post-procedural hydration rate.<br>|
| Other: Standard of Care<br>The control group will receive a peri and post-procedural hydration rate. | Other: Standard of Care plus peri-procedural hydration<br>* The control group will receive a peri and post-procedural hydration rate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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 | Through 30 days post-procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Kidney Function Between the Randomized Groups. |  | Up to 96 hours post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Kidney Injury, Iodinated Contrast Agent Retrieval, Coronary Sinus Cannulation