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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:4/21/2016
Start Date:August 2010
End Date:October 2015

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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

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.

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
We found this trial at
9
sites
550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, GA
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Albuquerque, New Mexico 87131
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Albuquerque, NM
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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Allentown, PA
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Bakersfield, California
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Bakersfield, CA
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Cincinnati, OH
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Danville, Pennsylvania 17882
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Danville, PA
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Pittsburgh, Pennsylvania
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Pittsburgh, PA
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Scranton, Pennsylvania
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Scranton, PA
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Sydney, New South Wales 2065
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Sydney,
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