A Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary PCI

Study Overview
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Brief Summary
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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
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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.

Official Title
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TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI

Conditions
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Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Percutaneous Coronary Intervention

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Referred for primary PCI Randomized within 12 hours of symptoms onset and prior to diagnostic angiography Informed consent Exclusion Criteria: Age ≤ 18 years Prior coronary artery bypass surgery (CABG) Life expectancy less than six months due to non-cardiac condition Treatment with fibrinolytic therapy for qualifying index STEMI event

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Upfront Thrombectomy followed by PCI<br>Upfront manual aspiration thrombectomy followed by PCI | Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy<br> <br> |
| Active Comparator: PCI Alone<br>PCI without upfront manual aspiration thrombectomy | Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, PCI, Percutaneous Coronary Intervention, STEMI, Thrombectomy