Status:
COMPLETED
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
Lead Sponsor:
Population Health Research Institute
Conditions:
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Eligibility:
All Genders
19+ years
Phase:
NA
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 aspir...
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 deat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
10732 Patients enrolled
Trial Details
Trial ID
NCT01149044
Start Date
August 1 2010
End Date
October 1 2015
Last Update
October 20 2015
Active Locations (87)
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1
Central Cardiology medical Clinic
Bakersfield, California, United States, 93308
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
3
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
4
Lindner Research Center at Christ Hospital
Cincinnati, Ohio, United States, 45219