Contrast-induced nephropathy disease of the kidneys
Conditions
Interventions
A specially designed balloon catheter is percutaneously inserted into the
jugular or femoral vein and positioning inside the coronary sinus to remove
contrast media from the cardiac circulation in p
Sponsors
Osprey Medical Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. The subject is at least 21 years of age. 2. The subject is a candidate for a therapeutic coronary PCI procedure of the left coronary artery (left main, left anterior descending coronary artery and/or left circumflex artery or branches of these vessels) anticipated to utilize at least 50 mL of iodinated contrast media (on the basis of a prior angiogram or pending angiographic confirmation). 3. The subject has documented CKD and an estimated eGFR > 20 and * 40 mL/min/1.73 m2 (as determined by the MDRD equation) ; or an eGFR> 40 and
Exclusion criteria
Exclusion criteria: 1. The subject is currently undergoing renal dialysis. 2. The subject is in acute renal failure or has unstable renal function based on clinical findings and/or a known change in serum creatinine of * 0.5mg/dL or * 25% within 7 days prior to enrollment compared to the last serum creatinine measurement on record. If the serum creatinine has risen to this degree, then at least 2 serum creatinine measures drawn >48 hours but 10 cc of contrast in total other than coronary angiography or PCI as described below. 5. The subject has a known allergy to iodine-based contrast agents that cannot be adequately pre-medicated (patients with a history of true anaphylaxis may not be enrolled). 6. 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. 7. The subject 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 bleeding gross genitourinary bleeding). 8. The subject is currently on intravenous heparin that cannot be discontinued at least 4 hours before the procedure, intravenous bivalirudin that cannot be discontinued at least 4 hours before the procedure, intravenous abciximab that cannot be discontinued at least 24 hours before the procedure, intravenous tirofiban or eptifibatide that cannot be discontinued at least 6 hours before the procedure, or has received any low molecular weight heparin within 12 hours or factor Xa antagonist (including fondaparinux) within 24 hours. 9. 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. 10. The subject is hypotensive (systolic blood pressure < 90 mmHg not corrected by intravenous saline) or requiring intravenous pressors and/or intra-aortic balloon counterpulsation. 11. The subject has decompensated heart failure requiring intravenous diuretic, inotropic, vasopressor or intraaortic balloon support in the previous 7 days. 12. The subject has had recent (within last 72 hours) acute myocardial infarction as defined in the *Universal Definition of Myocardial Infarction*: a. Detection of rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit and at least one of the following i. Symptoms of ischemia ii. ECG changes indicative of new ischemia (new ST-T changes or new left bundle branch block) iii. Development of pathological Q waves in the ECG iv. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality 13. The subject has undergone previous procedures involving
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety : * To describe the safety of the CINCOR* System by analysing all system related adverse events and calculating the serious system related event-free rate at 30 days post-procedure. Performance: * Rate of successful coronary sinus cannulation * Time required for coronary sinus cannulation * Volume of contrast agent used to place the Removal Catheter * Diameter of the coronary sinus based on fluoroscopy images * Total fluoroscopy time * Total volume of blood collected during removal episodes | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the rate of CIN in treated patients compared to historical controls. To summarize the change in serum creatinine and estimated glomerular filtration (eGFR) pre-procedure to 1 day and 4 days post-procedure. Evaluate the percent of contrast media removal as a sub-study in selected centers To describe the safety of the CINCOR* System by summarizing all system related adverse events and estimating the serious system related event-free rate through 30 days post-procedure. To estimate the rate of all Adverse Events (AE). To estimate the rate of the following AEs: Blood loss/bleeding meeting one of the following conditions: Requires transfusion of * 2 units Meets the definition for Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Coronary sinus perforation, dissection, or occlusion that requires treatment or results in MI or death Pericardial effusions (including pericardial tamponade) requiring treatment Death Myocardial infarction Arrhythmias Other events related to partial coronary sinus occlusion and suction | — |
Countries
Netherlands
Outcome results
None listed