None listed
Conditions
Brief summary
The purpose of this clinical study is to evaluate the effectiveness of the procedure for contrast removal as well as describe the safety and device performance of the Osprey Medical CINCOR Contrast Removal System, in patients with chronic kidney disease who are schedule to undergo diagnostic or therapeutic percutaneous coronary interventional procedures.
Interventions
The Osprey Medical CINCOR System utilizes catheter system along with institutional vacuum in which contrast media (CM) injected into the left coronary arteries is retrieved from the coronary sinus (CS). The
investigational device works by retrieving contrast agent prior to reaching the systemic circulation and the kidneys thereby helping to avoid the development of contrast induced nephropathy (CIN).
The removal catheter will be in place in the coronary sinus for the duration of the PCI proce
The Osprey Medical CINCOR System utilizes catheter system along with institutional vacuum in which contrast media (CM) injected into the left coronary arteries is retrieved from the coronary sinus (CS). The investigational device works by retrieving contrast agent prior to reaching the systemic circulation and the kidneys thereby helping to avoid the development of contrast induced nephropathy (CIN). The removal catheter will be in place in the coronary sinus for the duration of the PCI procedure (approximately 1 to 2 hours). Each collection episode will require that the vacuum is activated for approximately 8-12 seconds. It is anticipated that up to 12 collection episodes will occur during a PCI procedure.
Sponsors
Osprey Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject is at least 18 years of age. 2. The subject is a candidate for a diagnostic or therapeutic coronary percutanous coronary interventional (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. 3. The subject has documented chronic kidney disease and an estimated estimated glomerular filtration rate (eGFR) > 15 and < 60 mL/min/1.73m2 [as determined by the Modification of Diet on Renal Disease (MDRD) equation]. 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 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 greater than or equal to 0.5mg/dL or greater than or equal to 25% within 7 days prior to enrolment compared to the last serum creatinine measurement on record. 3. The subject has received contrast media within 7 days prior to the procedure day or a second imaging study of any type which will require iodinated contrast is planned within the 4 days following the protocol-defined procedure. 4. 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). 5. The subject has a known bleeding diathesis (e.g. thrombocytopenia [<100,000 cells/mm3], heparin-induced thrombocytopenia, haemophilia, or von Willebrand disease, any history of intracranial bleeding, or gastrointestinal bleeding gross genitourinary bleeding). 6. 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 of the procedure. 7. The subject is hypotensive (systolic blood pressure < 90 mmHg not corrected by intravenous saline) or requiring intravenous pressors and/or intra-aortic balloon counterpulsation. 8. The subject has decompensated heart failure requiring intravenous diuretic, inotropic, vasopressor or intraaortic balloon support in the previous 7 days. 9. 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. Electrocardiogram (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 10. The subject requires an intra aortic balloon pump. 11. The subject has an International Normalized Ratio (INR) > 1.8 pre-procedure. 12. The subject has an active bacterial infection within the last month. 13. The subject has haemoglobin (Hb) < 10.0 g/dL within one (1) week of the procedure. 14. 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). 15. The subject has a life expectancy of less than twelve (12) months. 16. The subject has a pacemaker lead, percutaneous mitral annuloplasty or other device placed within the coronary sinus that would limit the ability to successfully cannulated the coronary sinus. 17. The subject has an unstable clinical situation precluding placement or operation of the Osprey Medical CINCOR System. 18. The subject is currently participating in another investigational device or drug study that has not completed its primary endpoint.
Outcome results
None listed