Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upfront Thrombectomy followed by PCI | Active Comparator | Upfront manual aspiration thrombectomy followed by PCI |
|
| PCI Alone | Active Comparator | PCI without upfront manual aspiration thrombectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention with or without manual aspiration thrombectomy | Procedure |
|
| 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 |
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome at 30 days and 1 year | up to 1 year | |
| Components of primary outcome and secondary outcomes | CV death, MI, cardiogenic shock, new or worsening class IV heart failure, stroke, stent thrombosis, target vessel revascularization assessed separately at 30 days, 180 days and one year |
Inclusion Criteria:
Patients presenting with:
Referred for primary PCI
Randomized within 12 hours of symptoms onset and prior to diagnostic angiography
Informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sanjit S. Jolly, MD, MSc, FRCP | Hamilton Health Sciences Corporation | Principal Investigator |
| Vladimir DžavÃk, MD, FRCPC | Peter Munk Cardiac Centre, University Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Cardiology medical Clinic | Bakersfield | California | 93308 | United States | ||
| Emory University Hospital Midtown |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24576514 | Background | Jolly SS, Cairns J, Yusuf S, Meeks B, Shestakovska O, Thabane L, Niemela K, Steg PG, Bertrand OF, Rao SV, Avezum A, Cantor WJ, Pancholy SB, Moreno R, Gershlick A, Bhindi R, Welsh RC, Cheema AN, Lavi S, Rokoss M, Dzavik V. Design and rationale of the TOTAL trial: a randomized trial of routine aspiration ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI. Am Heart J. 2014 Mar;167(3):315-321.e1. doi: 10.1016/j.ahj.2013.12.002. Epub 2013 Dec 14. | |
| 25853743 |
| Label | URL |
|---|---|
| TOTAL - A Randomized Trial of Routine Aspiration Thrombectomy with Percutaneous Coronary Intervention (PCI) vs. PCI Alone in Patients with STEMI Undergoing Primary PCI (Population Health Research Institute) | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| up to 1 year |
| All-cause mortality | All-cause mortality at 30 days, 180 days and 1 year | up to 1 year |
| Composite of CV death, MI, cardiogenic shock, or new or worsening NYHA class IV heart failure at 30 days, 180 days | Composite of cardiovascular death, myocardial infarction, cardiogenic shock, or new or worsening NYHA class IV heart failure at 30 days, 180 days | up to 180 days |
| TIMI flow rates, no reflow | up to 1 year |
| Stent thrombosis | up to 1 year |
| Distal embolization | up to 1 year |
| Left main thrombus as a complication of the PCI procedure | up to 1 year |
| Target Vessel dissection | up to 1 year |
| Left main dissection | up to 1 year |
| Major Bleeding | up to 1 year |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87131 | United States |
| Lindner Research Center at Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| Geisinger Clinic | Danville | Pennsylvania | 17822 | United States |
| WPAHS - Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Northeast Clinical Trials Group | Scranton | Pennsylvania | 18510 | United States |
| Royal North Shore Hospital | Sydney | New South Wales | Australia |
| St. George Public Hospital | Sydney | New South Wales | Australia |
| Gold Coast Hospital | Southport | Queensland | Australia |
| Medical University of Vienna | Vienna | Austria |
| CHR de la Citadelle | Liège | Belgium |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital Santa Isabel | Blumenau | Santa Catarina | Brazil |
| Santa Casa de Marilia | MarÃlia | São Paulo | Brazil |
| Fundação Faculdade de Medicina de São José do Rio Preto | São José do Rio Preto | São Paulo | Brazil |
| Hospital Mae de Deus | Porto Elegre | Brazil |
| Instituto Dante Pazzanese de Cardiologia | São Paulo | Brazil |
| Royal Alexandra Hospital | Edmonton | Alberta | Canada |
| University of Alberta | Edmonton | Alberta | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | Canada |
| Victoria Heart Institute | Victoria | British Columbia | Canada |
| Royal Columbian Hospital | Westminster | British Columbia | Canada |
| Queen Elizabeth II Health Sciences | Halifax | Nova Scotia | Canada |
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| York PCI Group - Southlake Regional | Newmarket | Ontario | Canada |
| Scarborough Cardiology Research | Scarborough Village | Ontario | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Toronto General Hospital | Toronto | Ontario | Canada |
| CSSS de Chicoutimi | Chicoutimi | Quebec | Canada |
| MUHC Royal Victoria Hospital | Montreal | Quebec | Canada |
| Quebec Heart Lung Insitute | Québec | Quebec | Canada |
| Shanghai Gongli Hospital | Shanghai | China |
| The First People's Hospital, Jiatong University | Shanghai | China |
| The Tenth People's Hospital Tongji University | Shanghai | China |
| Yueyang Hospital Shanghai University of TCM | Shanghai | China |
| Krasjska Nemocnice Liberec | Liberec | Czechia |
| University Hospital Pilsen | Pilsen | Czechia |
| University Hospital Kralovske Vinohrady | Prague | Czechia |
| University Hospital Motol | Prague | Czechia |
| Masaryk Hospital | Ústà nad Labem | Czechia |
| Kuopio University Hospital | Kuopio | Finland |
| Heart Center, Tampere University Hospital | Tampere | Finland |
| Chu Jean Minjoz | Besançon | France |
| CHU Albert Michallon | Grenoble | France |
| Hopital Bichat | Paris | France |
| Hopital Lariboisiere Ap-HP | Paris | France |
| Centre Hospitalier de Pau | Pau | France |
| Universitatsklinikum Bonn | Bonn | Germany |
| Elisabeth-Krankenhaus Essen | Essen | Germany |
| Clinical Association Oberallgaeu-Kempten | Immenstadt im Allgäu | Germany |
| Klinikum der Universitat Munchen | München | Germany |
| Patras University Hospital | Pátrai | Greece |
| Ahepa University Hospital | Thessaloniki | Greece |
| Semmelweis University Heart and Vascular Center | Budapest | Hungary |
| University of Szeged | Szeged | Hungary |
| St. Antonius Ziekenhuis | Nieuwegein | Netherlands |
| Waikato Hospital | Hamilton | New Zealand |
| Medical University Skopje | Skopje | North Macedonia |
| Clinical Center of Serbia | Belgrade | Serbia |
| Soonchunhyang University Cheonan Hospital | Cheonan | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Kyung-Hee University Hospital | Seoul | South Korea |
| Seoul Boramae Medical Center | Seoul | South Korea |
| 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 |
| Hospital Son Espases | Palma de Mallorca | Spain |
| Hospital Clinico Universitario de Vigo | Vigo | Spain |
| Hampshire Hospitals NHS Fuondation Trust | Basingstoke | United Kingdom |
| Barts and The London Heart and Chest Centre | Bethnal Green | 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 |
| University Hospital South Manchester | Manchester | United Kingdom |
| Queen Elizabeth the Queen Mother Hospital | Margate | United Kingdom |
| Sheffield Teaching Hospitals | Sheffield | United Kingdom |
| University Hospital Southampton | Southampton | United Kingdom |
| Musgrove Park Hospital | Taunton | United Kingdom |
| Result |
| Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Dzavik V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16. |
| 35580203 | Derived | Alkhalil M, Kuzemczak M, Zhao R, Kavvouras C, Cantor WJ, Overgaard CB, Lavi S, Sharma V, Chowdhary S, Stankovic G, Kedev S, Bernat I, Bhindi R, Sheth T, Niemela K, Jolly SS, Dzavik V. Prognostic Role of Residual Thrombus Burden Following Thrombectomy: Insights From the TOTAL Trial. Circ Cardiovasc Interv. 2022 May;15(5):e011336. doi: 10.1161/CIRCINTERVENTIONS.121.011336. Epub 2022 May 17. |
| 33769510 | Derived | Moxham R, Dzavik V, Cairns J, Natarajan MK, Bainey KR, Akl E, Tsang MB, Lavi S, Cantor WJ, Madan M, Liu YY, Jolly SS. Association of Thrombus Aspiration With Time and Mortality Among Patients With ST-Segment Elevation Myocardial Infarction: A Post Hoc Analysis of the Randomized TOTAL Trial. JAMA Netw Open. 2021 Mar 1;4(3):e213505. doi: 10.1001/jamanetworkopen.2021.3505. |
| 30261959 | Derived | Jolly SS, Cairns JA, Lavi S, Cantor WJ, Bernat I, Cheema AN, Moreno R, Kedev S, Stankovic G, Rao SV, Meeks B, Chowdhary S, Gao P, Sibbald M, Velianou JL, Mehta SR, Tsang M, Sheth T, Dzavik V; TOTAL Investigators. Thrombus Aspiration in Patients With High Thrombus Burden in the TOTAL Trial. J Am Coll Cardiol. 2018 Oct 2;72(14):1589-1596. doi: 10.1016/j.jacc.2018.07.047. |
| 27056766 | Derived | Sheth TN, Kajander OA, Lavi S, Bhindi R, Cantor WJ, Cheema AN, Stankovic G, Niemela K, Natarajan MK, Shestakovska O, Tittarelli R, Meeks B, Jolly SS. Optical Coherence Tomography-Guided Percutaneous Coronary Intervention in ST-Segment-Elevation Myocardial Infarction: A Prospective Propensity-Matched Cohort of the Thrombectomy Versus Percutaneous Coronary Intervention Alone Trial. Circ Cardiovasc Interv. 2016 Apr;9(4):e003414. doi: 10.1161/CIRCINTERVENTIONS.115.003414. |
| 26474811 | Derived | Jolly SS, Cairns JA, Yusuf S, Rokoss MJ, Gao P, Meeks B, Kedev S, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemela K, Bernat I, Cantor WJ, Cheema AN, Steg PG, Welsh RC, Sheth T, Bertrand OF, Avezum A, Bhindi R, Natarajan MK, Horak D, Leung RC, Kassam S, Rao SV, El-Omar M, Mehta SR, Velianou JL, Pancholy S, Dzavik V; TOTAL Investigators. Outcomes after thrombus aspiration for ST elevation myocardial infarction: 1-year follow-up of the prospective randomised TOTAL trial. Lancet. 2016 Jan 9;387(10014):127-35. doi: 10.1016/S0140-6736(15)00448-1. Epub 2015 Oct 22. |
| 26129947 | Derived | Jolly SS, Cairns JA, Yusuf S, Meeks B, Gao P, Hart RG, Kedev S, Stankovic G, Moreno R, Horak D, Kassam S, Rokoss MJ, Leung RC, El-Omar M, Romppanen HO, Alazzoni A, Alak A, Fung A, Alexopoulos D, Schwalm JD, Valettas N, Dzavik V; TOTAL Investigators. Stroke in the TOTAL trial: a randomized trial of routine thrombectomy vs. percutaneous coronary intervention alone in ST elevation myocardial infarction. Eur Heart J. 2015 Sep 14;36(35):2364-72. doi: 10.1093/eurheartj/ehv296. Epub 2015 Jun 29. |
| 22000582 | Derived | Williams PD, Mamas MA, Fraser DG. A coronary artery cast. Can J Cardiol. 2011 Nov-Dec;27(6):871.e5-6. doi: 10.1016/j.cjca.2011.08.108. Epub 2011 Oct 14. No abstract available. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided