Reduction of contrast induced nephropathy (CIN) in patients requiring a percutaneous coronary intervention procedure and have chronic renal failure.
Not Applicable
Completed
- Conditions
- Cardiovascular disease in patients with chronic kidney disease.Renal and Urogenital - Kidney diseaseCardiovascular - Diseases of the vasculature and circulation including the lymphatic system
- Registration Number
- ACTRN12612000238875
- Lead Sponsor
- Osprey Medical Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
Chronic renal disease and requires a percutaneous coronary intervention procedure.
Exclusion Criteria
Not eligable for percutaneous coronary procedure or has an allergy to contrast media, unable/unwilling to provide consent, is pregnant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Device performance, measured by analysing successful use of the system and amount of contrast removed from the participant.[Day of surgery.]
- Secondary Outcome Measures
Name Time Method Device safety, assessed by analysing adverse events. Adverse events of interest include bleeding, myocardial infarction, dialysis and heart arrhythmias. Adverse events rates will be compared with rates of previous clinical trials conducted on the CINCOR system and rates experienced in percutaneous coronary intervention procedures.[24 hours, 4 days and 30 days post percutaneous coronary procedure.]