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
- Conditions
- Acute Coronary SyndromePercutaneous Coronary InterventionST Elevation Myocardial Infarction
- Interventions
- Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy
- Registration Number
- NCT01149044
- Lead Sponsor
- Population Health Research Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10732
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCI Alone Percutaneous Coronary Intervention with or without manual aspiration thrombectomy PCI without upfront manual aspiration thrombectomy Upfront Thrombectomy followed by PCI Percutaneous Coronary Intervention with or without manual aspiration thrombectomy Upfront manual aspiration thrombectomy followed by PCI
- Primary Outcome Measures
Name Time Method 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
Name Time Method Stroke up to 30 days 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 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
Trial Locations
- Locations (87)
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Hospital Santa Isabel
🇧🇷Blumenau, Santa Catarina, Brazil
Royal North Shore Hospital
🇦🇺Sydney, New South Wales, Australia
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Kyung-Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Central Cardiology medical Clinic
🇺🇸Bakersfield, California, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Geisinger Clinic
🇺🇸Danville, Pennsylvania, United States
St. George Public Hospital
🇦🇺Sydney, New South Wales, Australia
CHR de la Citadelle
🇧🇪Lige, Belgium
Medical University of Vienna
🇦🇹Vienna, Austria
Gold Coast Hospital
🇦🇺Southport, Queensland, Australia
Hospital Sao Lucas - PUCRS
🇧🇷Porto Alegre, RS, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Santa Casa de Marilia
🇧🇷Marilia, Sao Paulo, Brazil
Fundação Faculdade de Medicina de São José do Rio Preto
🇧🇷Sao Jose do Rio Preto, Sao Paulo, Brazil
Hospital Mae de Deus
🇧🇷Porto Elegre, Brazil
Instituto Dante Pazzanese de Cardiologia
🇧🇷Sao Paulo, Brazil
Victoria Heart Institute
🇨🇦Victoria, British Columbia, Canada
Royal Columbian Hospital
🇨🇦Westminster, British Columbia, Canada
Queen Elizabeth II Health Sciences
🇨🇦Halifax, Nova Scotia, Canada
University of Szeged
🇭🇺Szeged, Hungary
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
London Health Sciences Centre
🇨🇦London, Ontario, Canada
York PCI Group - Southlake Regional
🇨🇦Newmarket, Ontario, Canada
Scarborough Cardiology Research
🇨🇦Scarborough, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
MUHC Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Shanghai Gongli Hospital
🇨🇳Shanghai, China
CSSS de Chicoutimi
🇨🇦Chicoutimi, Quebec, Canada
Quebec Heart Lung Insitute
🇨🇦Quebec City, Quebec, Canada
The First People's Hospital, Jiatong University
🇨🇳Shanghai, China
Krasjska Nemocnice Liberec
🇨🇿Liberec, Czech Republic
The Tenth People's Hospital Tongji University
🇨🇳Shanghai, China
Yueyang Hospital Shanghai University of TCM
🇨🇳Shanghai, China
University Hospital Pilsen
🇨🇿Pilsen, Czech Republic
University Hospital Motol
🇨🇿Prague, Czech Republic
University Hospital Kralovske Vinohrady
🇨🇿Praha, Czech Republic
Masaryk Hospital
🇨🇿Usti nad Labem, Czech Republic
Kuopio University Hospital
🇫🇮Kuopio, Finland
Heart Center, Tampere University Hospital
🇫🇮Tampere, Finland
Chu Jean Minjoz
🇫🇷Besancon, France
CHU Albert Michallon
🇫🇷Grenoble, France
Hopital Bichat
🇫🇷Paris, France
Hopital Lariboisiere Ap-HP
🇫🇷Paris, France
Elisabeth-Krankenhaus Essen
🇩🇪Essen, Germany
Centre Hospitalier de Pau
🇫🇷Pau, France
Universitatsklinikum Bonn
🇩🇪Bonn, Germany
Clinical Association Oberallgaeu-Kempten
🇩🇪Immenstadt, Germany
Klinikum der Universitat Munchen
🇩🇪Munchen, Germany
Patras University Hospital
🇬🇷Patras, Greece
Ahepa University Hospital
🇬🇷Thessaloniki, Greece
Soonchunhyang University Cheonan Hospital
🇰🇷Cheonan, Korea, Republic of
Semmelweis University Heart and Vascular Center
🇭🇺Budapest, Hungary
Seoul Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Medical University Skopje
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Hospital Universitari Germans Trias I Pujol
🇪🇸Baldona, Spain
Complexo Hospitalario A Coruna
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
University Hospital La Paz
🇪🇸Madrid, Spain
Barts and The London Heart and Chest Centre
🇬🇧Bethnal Green, United Kingdom
Hospital Clinico Universitario de Vigo
🇪🇸Vigo, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Spain
Hampshire Hospitals NHS Fuondation Trust
🇬🇧Basingstoke, United Kingdom
Frimley Park Hospital, NHS Foundation Trust
🇬🇧Camberley, United Kingdom
Hull and East Yorkshire Hospitals
🇬🇧Hull, United Kingdom
Kettering General Hospital
🇬🇧Kettering, United Kingdom
Glenfield General Hospital
🇬🇧Leicester, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Queen Elizabeth the Queen Mother Hospital
🇬🇧Margate, United Kingdom
University Hospital South Manchester
🇬🇧Manchester, United Kingdom
Sheffield Teaching Hospitals
🇬🇧Sheffield, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom
University Hospital Southampton
🇬🇧Southampton, United Kingdom
Waikato Hospital
🇳🇿Hamilton, New Zealand
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
Lindner Research Center at Christ Hospital
🇺🇸Cincinnati, Ohio, United States
WPAHS - Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Northeast Clinical Trials Group
🇺🇸Scranton, Pennsylvania, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada