NCT01149044

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,732 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndrome
• ST Elevation Myocardial Infarction
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Coronary Intervention with or without manual aspiration thrombectomy

Timeline

• Start date: 2010-08-01
• Primary completion: 2015-03-01
• Completion: 2015-10-01
• First posted: 2010-06-23
• Last updated: 2015-10-20

Locations

87 sites across 20 countries: United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Hungary, Netherlands, New Zealand, North Macedonia, Serbia, South Korea, Spain, United Kingdom