The purpose of this clinical study is to provide confirmation of the clinical safety and performance of the CINCOR* System in removing contrast in patients at risk of developing CIN who are undergoing percutaneous coronary procedures.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
* 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
Background summary
Retrospective studies of PCI databases indicate that chronic kidney disease
patients undergoing PCI procedures have increased in-hospital and long-term
morbidity and mortality.
Study objective
The purpose of this clinical study is to provide confirmation of the clinical
safety and performance of the CINCOR* System in removing contrast in patients
at risk of developing CIN who are undergoing percutaneous coronary procedures.
Study design
This is a prospective, single arm clinical trial. All enrolled patients will
be followed through 30 days post-procedure.
Intervention
Placing contrast medium removal system CINCOR* in sinus coronarius during PCI
Study burden and risks
nature and extent of burden consists of additional visits (3x) either to the
hospital or visits or b telephone. Extra venous puncture (3 times)
Prolongation of the procedure by 10 minutes. Extra Fluoroscopy
Risks dissection, sinus coronarius perforation, dissection of occlusion.
Pulmonary embolism. Rythm disorders.
7600 EXECUTIVE DRIVE
EDEN PRAIRIE, MN 55344
US
7600 EXECUTIVE DRIVE
EDEN PRAIRIE, MN 55344
US
Listed location countries
Age
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 < 60 mL/min/1.73 m2 and one or more of the following co-morbidities: stage III/IV congestive heart failure (as defined by NYHA criteria), diabetes mellitus, or 75 years of age or greater.
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36962.018.11 |