None listed
Conditions
Brief summary
The purpose of this clinical study is to assess the safety and ease of use of the Osprey Medical Contrast Induced Nephropathy System in contrast retrieval during/after diagnostic or interventional percutaneous coronary procedure
Interventions
Contrast retrieval after diagnostic or interventional coronary procedure (e.g. angiogram), 30 day follow-up post procedure, evaluation the safety of the Osprey Medical Contrast System used to retrieve contrast (dye) from the coronary sinus before the dye can damage the kidneys. The device is used for a few seconds after a patient is injected with contrast
Sponsors
Osprey Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The subject is at least 18 years of age, is a candidate for diagnostic or interventional percutaneous coronary procedure utilizing contrast has documented CKD and an estimated GFR is <60 and > 15 ml/min/1.73 m2 , 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
Subject is know to be or suspected to be pregnant, has a life expectancy of less than twelve (12) months, is allergic to contrast media nickel and/or titanium, has a known bleeding disorder (e.g., bleeding -including thrombocytopenia [< 100,000 platelet count], heparin-induced thrombocytopenia, hemophilia, or von Willebrand disease), is unavailable for follow-up, has undergone percutaneous diagnostic or therapeutic procedure within 72 hours of the proposed contrast removal procedure, is currently participating in another investigational device or drug study, has a pacemaker lead or other device placed within the coronary sinus, has had a percutaneous mitral annuloplasty with the device placed in the coronary sinus, has diagnosis of NYHA Class IV heart failure or has had recent exacerbation of heart failure requiring hospitalization within last four weeks or baseline BNP of 900 or greater, has had an acute myocardial infarction within the last 72 hours, INR > 1.8 within one (1) week of the procedure, has an active infection within the last month and/or WBC is > 10.0, has a Hb < 10.0 within one (1) week of the procedure, is not an appropriate candidate for catheterization of the coronary arteries or coronary sinus, unstable clinical situation precluding placement or operation of the Osprey Medical Contrast Removal System coronary sinus catheter, the Principal Investigator determines the subject is not an appropriate candidate for the study.
Outcome results
None listed