Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients
ACST-2
Asymptomatic Carotid Surgery Trial-2 (ACST-2): an International Randomised Trial to Compare Carotid Endarterectomy With Carotid Artery Stenting to Prevent Stroke
1 other identifier
interventional
3,638
29 countries
118
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
118 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 15, 2009
CompletedFirst Posted
Study publicly available on registry
April 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedDecember 9, 2024
May 1, 2024
12.9 years
April 15, 2009
December 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (1)
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
Study Arms (2)
CEA
ACTIVE COMPARATORCarotid endarterectomy
CAS
ACTIVE COMPARATORCarotid Artery Stenting
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- NHS Health Technology Assessment Programmecollaborator
- BUPA Foundationcollaborator
- British Heart Foundationcollaborator
Study Sites (125)
University of Toledo Medical Centre
Toledo, Ohio, 43614, United States
Medical University of Innsbruck
Innsbruck, Austria
University Hospital Antwerp
Antwerp, Belgium
University St Lucas
Brussels, Belgium
Az St Blasius
Dendermonde, Belgium
University Hospital Gent
Ghent, Belgium
Centre Hospitalier Régional de la Citadelle
Liège, Belgium
Centre Hospitalier De Mouscron
Mouscron, Belgium
HCFM Ribeirao Preto da Universidade de Sao Paulo
São Paulo, Brazil
University of Sao Paulo
São Paulo, Brazil
Sveta Marina Hospital
Varna, Bulgaria
Foothills Medical Centre
Calgary, Canada
China-Japan Friendship Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
University Hospital Centre Zagreb
Zagreb, Croatia
University Hospital of Merkur
Zagreb, Croatia
St Anne's University Hospital Brno
Brno, Czechia
Hospital Ceské Budejovice
České Budějovice, Czechia
Regional Hospital Liberec
Liberec, Czechia
University Hospital Ostrava Poruba
Ostrava Poruba, Czechia
Central Military Hospital
Prague, Czechia
Kasr Alaini University Hospital
Cairo, Egypt
East Tallinn general Hospital
Tallinn, Estonia
Henri Mondor University Hospital
Paris, France
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
Münster, Germany
Hegau-Bodensee-Klinikum
Singen, Germany
Democritus University of Thrace
Alexandroupoli, 68100, Greece
Dept. of Vascular Surgery, Attikon University Hospital
Athens, Greece
University Hospital of Larissa
Larissa, Greece
Semmelweis Medical University
Budapest, Hungary
Albert Szent-Györgyi Medical Centre
Szeged, Hungary
St. James' Hospital
Dublin, Ireland
Rambam Hospital
Haifa, Israel
Cefalu Fondazione Istituto G.Giglio
Cefalù, PA, 90015, Italy
Azienda Ospedaliera S.G Moscati
Avellino, Italy
University of Bari
Bari, Italy
University of Bologna
Bologna, Italy
Policlinico Catania
Catania, Italy
Azienda Ospedaliero-Universitaria S.Anna
Ferrera, Italy
San Giovanni Di Dio
Florence, Italy
Opsedale Villa Scassi
Genoa, 16149, Italy
IRCCS San Martino
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, 00128, 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, 20089, Italy
Santa Maria alle Scotte
Siena, Italy
Ospedali Riuniti di Trieste
Trieste, 34142, Italy
Umberto I- ASO Mauriziano
Turin, Italy
Circolo University Hospital
Varese, Italy
San Giacomo Hospital
Veneto, Italy
Sendai Medical Centre
Sendai, Japan
National Scientific Centre of Surgery
Almaty, Kazakhstan
Rijnstate Hospital
Arnhem, Netherlands
MCL Leeuwarden
Leeuwarden, Netherlands
University Hospital Utrecht
Utrecht, Netherlands
Rikshospitalet
Oslo, Norway
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, Poland
Hospital Santa Marta
Lisbon, 1150, Portugal
Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, Russia
Saint Petersburg Scientific Research Institute for Emergency Care
Saint Petersburg, Russia
V.A. Almazov National Medical Research Centre
Saint Petersburg, Russia
Dedinje Cardiovascular Unit
Belgrade, Serbia
Serbian Clinical Centre
Belgrade, Serbia
Institute of Medical Sciences
Ružomberok, Slovakia
Izola General Hospital
Izola, Slovenia
Teaching Hospital Maribor
Maribor, Slovenia
Hospital Clinic 1 Provinical de Barcelona
Barcelona, Spain
Guadalajara Hospital
Guadalajara, Spain
Hospital Universitari I Politecnic La Fe
Valencia, Spain
Lasarettet Helsingborg
Helsingborg, Sweden
Malmo University Hospital
Malmo, Sweden
Sodersjukhuset
Stockholm, Sweden
Cantonal Hospital Aarau
Aarau, CH-5001, Switzerland
University of Basel
Basel, Switzerland
Southend University Hospital
Westcliff-on-Sea, Essex, United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury, Kent, United Kingdom
Walton Centre
Aintree, 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
North Cumbria University Hospital
Whitehaven, United Kingdom
Related Publications (1)
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. doi: 10.1016/S0140-6736(04)16146-1.
PMID: 15135594BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alison Halliday
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2009
First Posted
April 17, 2009
Study Start
January 1, 2008
Primary Completion
December 1, 2020
Study Completion
December 1, 2025
Last Updated
December 9, 2024
Record last verified: 2024-05