chronic kidney disease
Conditions
Interventions
Placing contrast medium removal system CINCOR* in sinus coronarius during PCI
Sponsors
Osprey Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 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). 2. 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 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 30 days following the protocol-defined procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: To describe the safety of the CINCOR* System by analyzing 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 * 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: o Blood loss/bleeding meeting one of the following conditions: - Requires transfusion of * 2 units - Thrombolysis in Myocardial Infarction (TIMI) Major bleeding - TIMI for Minor bleeding | — |
Countries
Netherlands
Outcome results
None listed