Carotid Stenosis Clinical Trial
— ACST-2Official title:
Asymptomatic Carotid Surgery Trial-2 (ACST-2): an International Randomised Trial to Compare Carotid Endarterectomy With Carotid Artery Stenting to Prevent Stroke
NCT number | NCT00883402 |
Other study ID # | ACST-2 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2008 |
Est. completion date | December 2020 |
The trial randomise patients with asymptomatic carotid artery narrowing in whom prompt
physical intervention is thought to be needed, but there there is still substantial
uncertainty shared by patient and doctor about whether surgery or stenting is the more
appropriate choice.
The study is looking at immediate risks (within one month)and at long term benefits
Status | Recruiting |
Enrollment | 3600 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Carotid artery stenosis detectable by duplex ultrasound, with no ipsilateral carotid territory symptoms(or none for some months) and no previous procedure done on it, which might well need procedural treatment now with CEA or CAS. - Already started any appropriate medical treatment (eg, statin, aspirin etc), and already recovered from any necessary coronary procedures (eg, CABG) - Patient seems fit and willing for follow-up in person (at 1 month) and by annual letter (for at least 5 years) - Investigations show that both procedures (CEA and CAS) appear to be practicable and appropriate - Some type of angiography (eg, MRA or CTA) has already been done that has shown that CEA and CAS would both be anatomically practicable. - Doctor and patient both substantially uncertain about whether to treat with CEA or CAS, and the doctor sees no clear indication/contra-indication for either procedure Exclusion Criteria: - Small likelihood of worthwhile benefit (eg, very low risk of stroke because stenosis is very minor, or major co-morbidity or life-threatening disease, such as advanced cancer) - Unsuitable for one or other procedure (eg, stenosis at carotid siphon that is inaccessible for CEA, or complex vasculature below the stenosis that would hinder CAS, or patient unfit for major surgery) |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Innsbruck | Innsbruck | |
Belgium | University Hospital Antwerp | Antwerp | |
Belgium | University St Lucas | Brussels | |
Belgium | Az St Blasius | Dendermonde | |
Belgium | University Hospital Gent | Gent | |
Belgium | Centre Hospitalier Régional de la Citadelle | Liege | |
Belgium | Centre Hospitalier De Mouscron | Mouscron | |
Brazil | University of Sao Paulo | Sao Paulo | |
Brazil | HCFM Ribeirao Preto da Universidade de Sao Paulo | São Paulo | |
Bulgaria | Sveta Marina Hospital | Varna | |
Canada | Foothills Medical Centre | Calgary | |
China | China-Japan Friendship Hospital | Beijing | |
China | Peking Union Medical College Hospital | Beijing | |
Croatia | University Hospital Centre Zagreb | Zagreb | |
Croatia | University Hospital of Merkur | Zagreb | |
Czechia | St Anne's University Hospital Brno | Brno | |
Czechia | Hospital Ceské Budejovice | Ceské Budejovice | |
Czechia | Regional Hospital Liberec | Liberec | |
Czechia | University Hospital Ostrava Poruba | Ostrava Poruba | |
Czechia | Central Military Hospital | Prague | |
Egypt | Kasr Alaini University Hospital | Cairo | |
Estonia | East Tallinn general Hospital | Tallinn | |
France | Henri Mondor University Hospital | Paris | |
Germany | University of Dresden 'Carl-Gustav-Carus' | Dresden | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Universitätsklinik Jena | Jena | |
Germany | Städtisches Klinikum Karlsruhe | Karlsruhe | |
Germany | University of Leipzig | Leipzig | |
Germany | Universitätsmedizin Mannheim | Mannheim | |
Germany | Klinikum rechts der Isar derTechnischen Universität Muenchen | Munich | |
Germany | St Franziskus-Hospital Münster GmbH | Munster | |
Germany | Hegau-Bodensee-Klinikum | Singen | |
Greece | Democritus University of Thrace | Alexandroupolis | |
Greece | Dept. of Vascular Surgery, Attikon University Hospital | Athens | |
Greece | University Hospital of Larissa | Larissa | |
Hungary | Semmelweis Medical University | Budapest | |
Hungary | Albert Szent-Györgyi Medical Centre | Szeged | |
Ireland | St. James' Hospital | Dublin | |
Israel | Rambam Hospital | Haifa | |
Italy | Azienda Ospedaliera S.G Moscati | Avellino | |
Italy | University of Bari | Bari | |
Italy | University of Bologna | Bologna | |
Italy | Policlinico Catania | Catania | |
Italy | Cefalu Fondazione Istituto G.Giglio | Cefalu | PA |
Italy | Azienda Ospedaliero-Universitaria S.Anna | Ferrera | |
Italy | San Giovanni Di Dio | Florence | |
Italy | IRCCS San Martino | Genoa | |
Italy | Opsedale Villa Scassi | Genoa | |
Italy | Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano | Milan | |
Italy | IRCCS Policlinico San Donato | Milan | |
Italy | Istituto Auxologico Italiano | Milan | |
Italy | San Paolo Hospital | Milan | |
Italy | Mirano Hospital | Mirano | |
Italy | Nuovo Ospedale Civile Sant' Agostino Estense | Modena | |
Italy | Policlinico di Monza | Monza | |
Italy | Ospedale San Francesco di Nuoro | Nuoro | |
Italy | University of Palermo | Palermo | |
Italy | Foundation IRCCS Policlinico San Matteo | Pavia | |
Italy | Vascular Endovascular Unit of Perugia | Perugia | |
Italy | Santa Maria Hospital - Reggio | Raggio | |
Italy | Policlinico Universitario Campus Bio-medico di Roma | Roma | |
Italy | A.C.O. San Fillippo Neri | Rome | |
Italy | Fondazione Policlinico U. Agostino Gemeli IRCCS | Rome | |
Italy | San Camillo Forlanini | Rome | |
Italy | University La Sapienza | Rome | |
Italy | IRCCS Clinico Humanitas | Rozzano | |
Italy | Santa Maria alle Scotte | Siena | |
Italy | Ospedali Riuniti di Trieste | Trieste | |
Italy | Umberto I- ASO Mauriziano | Turin | |
Italy | Circolo University Hospital | Varese | |
Italy | San Giacomo Hospital | Veneto | |
Japan | Sendai Medical Centre | Sendai | |
Kazakhstan | National Scientific Centre of Surgery | Almaty | |
Netherlands | Rijnstate Hospital | Arnhem | |
Netherlands | MCL Leeuwarden | Leeuwarden | |
Netherlands | University Hospital Utrecht | Utrecht | |
Norway | Rikshospitalet | Oslo | |
Poland | Poznan University of Medical Sciences | Poznan | |
Poland | Bielanski Hospital | Warsaw | |
Poland | Central Hospital Internal Aff. | Warsaw | |
Poland | Mazovian Brodnowski Hospital | Warsaw | |
Poland | University of Warsaw/ Institute of Psychiatry | Warsaw | |
Poland | Regional Specialist Hospital (Wroclaw) | Wroclaw | |
Portugal | Hospital Santa Marta | Lisbon | |
Russian Federation | Novosibirsk Research Institute of Circulation Pathology | Novosibirsk | |
Russian Federation | Saint Petersburg Scientific Research Institute for Emergency Care | Saint Petersburg | |
Russian Federation | V.A. Almazov National Medical Research Centre | Saint Petersburg | |
Serbia | Dedinje Cardiovascular Unit | Belgrade | |
Serbia | Serbian Clinical Centre | Belgrade | |
Singapore | Khoo Teck Puat Hospital | Singapore | |
Slovakia | Institute of Medical Sciences | Ruzomberok | |
Slovenia | Izola General Hospital | Izola | |
Slovenia | Teaching Hospital Maribor | Maribor | |
Spain | Hospital Clinic 1 Provinical de Barcelona | Barcelona | |
Spain | Guadalajara Hospital | Guadalajara | |
Spain | Hospital Universitari I Politecnic La Fe | Valencia | |
Sweden | Lasarettet Helsingborg | Helsingborg | |
Sweden | Malmo University Hospital | Malmo | |
Sweden | Sodersjukhuset | Stockholm | |
Switzerland | Cantonal Hospital Aarau | Aarau | |
Switzerland | University of Basel | Basel | |
United Kingdom | Walton Centre | Aintree | |
United Kingdom | East Kent Hospitals University NHS Foundation Trust | Canterbury | Kent |
United Kingdom | Cheltenham General Hospital | Cheltenham | |
United Kingdom | Bishop Auckland Hospital | Durham | |
United Kingdom | University Hospital of North Durham | Durham | |
United Kingdom | Hull Royal Infirmary | Hull | |
United Kingdom | St George's Hospital | London | |
United Kingdom | The Royal London | London | |
United Kingdom | Luton & Dunstable Hospital | Luton | |
United Kingdom | Manchester Royal Infirmary | Manchester | |
United Kingdom | Wythenshawe Hospital | Manchester | |
United Kingdom | James Cook Hospital | Middlesbrough | |
United Kingdom | Freeman Hospital | Newcastle | |
United Kingdom | Royal Victoria Infirmary | Newcastle | |
United Kingdom | Nottingham University Hospital | Nottingham | |
United Kingdom | John Radcliffe Hospital | Oxford | |
United Kingdom | Derriford Hospital | Plymouth | |
United Kingdom | The Royal Preston Hospital | Preston | |
United Kingdom | Royal Berkshire | Reading | |
United Kingdom | Sheffield Vascular Institute | Sheffield | |
United Kingdom | Sunderland Royal Hospital | Sunderland | |
United Kingdom | Great Western Hospital | Swindon | |
United Kingdom | Southend University Hospital | Westcliff-on-Sea | Essex |
United Kingdom | North Cumbria University Hospital | Whitehaven | |
United Kingdom | York Hospital | York | |
United States | University of Toledo Medical Centre | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | BUPA Foundation, NHS Health Technology Assessment Programme |
United States, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Netherlands, Norway, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom,
Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D; MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial. Lancet. 2004 May 8;363(9420):1491-502. Erratum in: Lancet. 2004 Jul 31;364(9432):416. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare peri-procedural risks (MI, stroke and death) within the first month after the allocated CEA or CAS and long-term (up to 5 or more years) prevention of stroke, particularly disabling or fatal stroke, in subsequent years. | 10 years | ||
Secondary | To identify types of patients to be identified in which one or other procedure is clearly preferable as well as economic evaluation; procedural costs and stroke-related healthcare costs and quality of life. | 10 years |
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