The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey Medical CINCOR™ Contrast Removal System.
The CINCOR™ Catheter System to retrieve contrast media from the coronary sinus following injection during percutaneous coronary interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
16
Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media
The control group will receive a peri and post-procedural hydration rate.
Heart Care Research, LLC
Huntsville, Alabama, United States
Incidence of Contrast Induced Nephropathy (CIN) in Subjects.
CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL).
Time frame: Through 72 hours post-procedure
Evaluating Bleeding/Transfusion Events.
Bleeding/transfusion events evaluated: * Blood loss requiring transfusion of ≥ 2 units * Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding * TIMI Minor Bleeding
Time frame: Through 30 days post-procedure
Evaluating Local Events.
Events evaluated include: * Coronary sinus perforation, dissection, or occlusion that requires treatment or results in MI or death * Pericardial effusions (including pericardial tamponade) requiring treatment
Time frame: Through 30 days post-procedure.
Change in Kidney Function Between the Randomized Groups.
Time frame: Up to 96 hours post-procedure
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