Acute Coronary Syndrome, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction
Conditions
Keywords
Acute Coronary Syndrome, PCI, Percutaneous Coronary Intervention, STEMI, Thrombectomy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPercutaneous Coronary Intervention with or without manual aspiration thrombectomy
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients presenting with: * Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND * Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads 2. Referred for primary PCI 3. Randomized within 12 hours of symptoms onset and prior to diagnostic angiography 4. Informed consent
Exclusion criteria
1. Age ≤ 18 years 2. Prior coronary artery bypass surgery (CABG) 3. Life expectancy less than six months due to non-cardiac condition 4. Treatment with fibrinolytic therapy for qualifying index STEMI event
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure | up to 180 days |
Secondary
| Measure | Time frame |
|---|---|
| Stroke | 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 | up to 1 year |
| Cardiovascular Mortality | 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 | up to 180 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stent thrombosis | up to 1 year | — |
| Distal embolization | up to 1 year | — |
| Left main thrombus as a complication of the PCI procedure | up to 1 year | — |
| Primary outcome at 30 days and 1 year | up to 1 year | — |
| Left main dissection | up to 1 year | — |
| Major Bleeding | up to 1 year | — |
| Target Vessel dissection | up to 1 year | — |
| Components of primary outcome and secondary outcomes | up to 1 year | CV death, MI, cardiogenic shock, new or worsening class IV heart failure, stroke, stent thrombosis, target vessel revascularization assessed separately at 30 days, 180 days and one year |
| All-cause mortality | up to 1 year | All-cause mortality at 30 days, 180 days and 1 year |
| Composite of CV death, MI, cardiogenic shock, or new or worsening NYHA class IV heart failure at 30 days, 180 days | up to 180 days | Composite of cardiovascular death, myocardial infarction, cardiogenic shock, or new or worsening NYHA class IV heart failure at 30 days, 180 days |
| TIMI flow rates, no reflow | up to 1 year | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Hungary, Netherlands, New Zealand, North Macedonia, Serbia, South Korea, Spain, United Kingdom, United States
Outcome results
None listed