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

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.

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

Inclusion Criteria:

1. The subject is at least 18 years of age.
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:

1. 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).

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.