The objective of this study is to demonstrate the safety and performance of the Indigo Aspiration System using the CAT RX aspiration catheter in a population presenting with acute high thrombus burden coronary vessel occlusion who are referred for Percutaneous Coronary Intervention (PCI).
Study Type
OBSERVATIONAL
Enrollment
400
Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
Cedars Sinai Medical Center
Los Angeles, California, United States
Composite of:
Cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association Class IV heart failure
Time frame: 30 days
Final TIMI Flow Grade
TIMI flow grading range 0-3, with higher grading representing better outcome
Time frame: Procedure
Final TIMI Thrombus Grade
TIMI Thrombus grading range 0-5, with lower grading representing better outcome
Time frame: Procedure
Myocardial Blush Grade
Myocardial blush grading range 0-3, with higher grading representing better outcome
Time frame: Procedure
Distal Embolization Rate
Time frame: Procedure
Stent Thrombosis
Time frame: 180 Days
Stroke
Time frame: 30 Days
Major Bleeding
Time frame: 30 Days
All-Cause Mortality
Time frame: 180 Days
Cardiovascular Death
Time frame: 180 Days
Recurrent MI
Time frame: 180 Days
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...and 15 more locations
Cardiogenic Shock
Time frame: 180 Days
Class IV Heart Failure
Time frame: 180 Days
Incident of Device Related SAEs
Time frame: 180 Days