This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.
The hypothesis for TOTAL is that the routine use of manual aspiration thrombectomy with an aspiration catheter (Export®) with PCI compared to PCI alone will reduce the incidence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure (HF) at 180 days in patients with STEMI undergoing primary PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10,732
Central Cardiology medical Clinic
Bakersfield, California, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Lindner Research Center at Christ Hospital
Cincinnati, Ohio, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure
Time frame: up to 180 days
Stroke
Time frame: up to 30 days
Key Net Benefit Outcome: The first occurence of CV death, MI, stroke, cardiogenic shock or new or worsening NHYA Class IV heart failure
Time frame: up to 1 year
Cardiovascular Mortality
Time frame: up to 180 days
Key Secondary Efficacy Outcome: The first occurence of cardiovascular death, myocardial infarction, cardiogenic shock, new or worsening NYHA class IV heart failure, stent thrombosis and target vessel revascularization
Time frame: up to 180 days
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Geisinger Clinic
Danville, Pennsylvania, United States
WPAHS - Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Northeast Clinical Trials Group
Scranton, Pennsylvania, United States
Royal North Shore Hospital
Sydney, New South Wales, Australia
St. George Public Hospital
Sydney, New South Wales, Australia
...and 77 more locations