Carotid StenosisACST-2NCT00883402
Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients
A study testing CEA, CAS in people with Carotid Stenosis, run by University of Oxford at 125 sites in 32 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- CEA, CAS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,638 participants
- Where
- 125 sitesin 32 countries
- Study dates
- Jan 2008to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
125 sites in 32 countries.
125 sites in 32 countries
Italy32 sites
Azienda Ospedaliera S.G Moscati
Avellino
University of Bari
Bari
University of Bologna
Bologna
Policlinico Catania
Catania
Cefalu Fondazione Istituto G.Giglio
Cefalù, PA, 90015
Azienda Ospedaliero-Universitaria S.Anna
Ferrera
San Giovanni Di Dio
Florence
Opsedale Villa Scassi
Genoa, 16149
IRCCS San Martino
Genoa
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano
Milan
IRCCS Policlinico San Donato
Milan
Istituto Auxologico Italiano
Milan
San Paolo Hospital
Milan
Mirano Hospital
Mirano
Nuovo Ospedale Civile Sant' Agostino Estense
Modena
Policlinico di Monza
Monza
Ospedale San Francesco di Nuoro
Nuoro
University of Palermo
Palermo
Foundation IRCCS Policlinico San Matteo
Pavia
Vascular Endovascular Unit of Perugia
Perugia
Santa Maria Hospital - Reggio
Raggio
Policlinico Universitario Campus Bio-medico di Roma
Roma, 00128
A.C.O. San Fillippo Neri
Rome
Fondazione Policlinico U. Agostino Gemeli IRCCS
Rome
San Camillo Forlanini
Rome
University La Sapienza
Rome
IRCCS Clinico Humanitas
Rozzano, 20089
Santa Maria alle Scotte
Siena
Ospedali Riuniti di Trieste
Trieste, 34142
Umberto I- ASO Mauriziano
Turin
Circolo University Hospital
Varese
San Giacomo Hospital
Veneto
United Kingdom24 sites
Walton Centre
Aintree
East Kent Hospitals University NHS Foundation Trust
Canterbury, Kent
Cheltenham General Hospital
Cheltenham
Bishop Auckland Hospital
Durham
University Hospital of North Durham
Durham
Hull Royal Infirmary
Hull
St George's Hospital
London
The Royal London
London
Luton & Dunstable Hospital
Luton
Manchester Royal Infirmary
Manchester
Wythenshawe Hospital
Manchester
James Cook Hospital
Middlesbrough
Freeman Hospital
Newcastle
Royal Victoria Infirmary
Newcastle
Nottingham University Hospital
Nottingham
John Radcliffe Hospital
Oxford
Derriford Hospital
Plymouth
The Royal Preston Hospital
Preston
Royal Berkshire
Reading
Sheffield Vascular Institute
Sheffield
Sunderland Royal Hospital
Sunderland
Great Western Hospital
Swindon
Southend University Hospital
Westcliff-on-Sea, Essex
North Cumbria University Hospital
Whitehaven
Germany9 sites
University of Dresden 'Carl-Gustav-Carus'
Dresden
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Universitätsklinik Jena
Jena
Städtisches Klinikum Karlsruhe
Karlsruhe
University of Leipzig
Leipzig
Universitätsmedizin Mannheim
Mannheim
Klinikum rechts der Isar derTechnischen Universität Muenchen
Munich
St Franziskus-Hospital Münster GmbH
Münster
Hegau-Bodensee-Klinikum
Singen
Belgium6 sites
University Hospital Antwerp
Antwerp
University St Lucas
Brussels
Az St Blasius
Dendermonde
University Hospital Gent
Ghent
Centre Hospitalier Régional de la Citadelle
Liège
Centre Hospitalier De Mouscron
Mouscron
Poland6 sites
Poznan University of Medical Sciences
Poznan
Bielanski Hospital
Warsaw
Central Hospital Internal Aff.
Warsaw
Mazovian Brodnowski Hospital
Warsaw
University of Warsaw/ Institute of Psychiatry
Warsaw
Regional Specialist Hospital (Wroclaw)
Wroclaw
Czechia5 sites
St Anne's University Hospital Brno
Brno
Hospital Ceské Budejovice
České Budějovice
Regional Hospital Liberec
Liberec
University Hospital Ostrava Poruba
Ostrava Poruba
Central Military Hospital
Prague
Greece3 sites
Democritus University of Thrace
Alexandroupoli, 68100
Dept. of Vascular Surgery, Attikon University Hospital
Athens
University Hospital of Larissa
Larissa
Netherlands3 sites
Rijnstate Hospital
Arnhem
MCL Leeuwarden
Leeuwarden
University Hospital Utrecht
Utrecht
Russia3 sites
Novosibirsk Research Institute of Circulation Pathology
Novosibirsk
Saint Petersburg Scientific Research Institute for Emergency Care
Saint Petersburg
V.A. Almazov National Medical Research Centre
Saint Petersburg
Spain3 sites
Hospital Clinic 1 Provinical de Barcelona
Barcelona
Guadalajara Hospital
Guadalajara
Hospital Universitari I Politecnic La Fe
Valencia
Sweden3 sites
Lasarettet Helsingborg
Helsingborg
Malmo University Hospital
Malmö
Sodersjukhuset
Stockholm
Brazil2 sites
HCFM Ribeirao Preto da Universidade de Sao Paulo
São Paulo
University of Sao Paulo
São Paulo
China2 sites
China-Japan Friendship Hospital
Beijing
Peking Union Medical College Hospital
Beijing
Croatia2 sites
University Hospital Centre Zagreb
Zagreb
University Hospital of Merkur
Zagreb
Hungary2 sites
Semmelweis Medical University
Budapest
Albert Szent-Györgyi Medical Centre
Szeged
Serbia2 sites
Dedinje Cardiovascular Unit
Belgrade
Serbian Clinical Centre
Belgrade
Slovenia2 sites
Izola General Hospital
Izola
Teaching Hospital Maribor
Maribor
Switzerland2 sites
Cantonal Hospital Aarau
Aarau, CH-5001
University of Basel
Basel
United States1 site
University of Toledo Medical Centre
Toledo, Ohio, 43614
About this study
Official title: Asymptomatic Carotid Surgery Trial-2 (ACST-2): an International Randomised Trial to Compare Carotid Endarterectomy With Carotid Artery Stenting to Prevent Stroke
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
- Conditions
- Carotid Stenosis
- Being tested
- CEA, CAS
- Keywords
- Carotid stenosis, CEA, CAS, Stenting
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEA, CASProcedure or surgery
Carotid Artery Stenting (CAS) Carotid endarterectomy (CEA)
| Study group | Role | What they receive |
|---|---|---|
| CEA | Active comparator | Carotid endarterectomy Receives: Procedure: CEA, CAS |
| CAS | Active comparator | Carotid Artery Stenting Receives: Procedure: CEA, CAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2020
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,638 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Health Technology Assessment Programme, Bupa Chile, British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Alison Halliday, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883402
- Sponsor's protocol ID
- ACST-2
- Acronym
- ACST-2
- Status last verified
- May 2024
- First submitted
- 15 Apr 2009
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15135594
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymptomatic Carotid Surgery Trial-2 (ACST-2): an International Randomised Trial to Compare Carotid Endarterectomy With Carotid Artery Stenting to Prevent Stroke
- ClinicalTrials.gov ID
- NCT00883402
- Acronym / sponsor ID
- ACST-2 / ACST-2
- Conditions
- Carotid Stenosis
- Keywords
- Carotid stenosis, CEA, CAS, Stenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,638 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- NHS Health Technology Assessment Programme, Bupa Chile, British Heart Foundation
- Study start
- Jan 2008
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEA | Active comparator | Procedure: CEA, CASCarotid endarterectomy |
| CAS | Active comparator | Procedure: CEA, CASCarotid Artery Stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEA, CASCarotid Artery Stenting (CAS) Carotid endarterectomy (CEA) | Procedure or surgery | CAS, CEA |
Primary outcome
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.
Time frame: 10 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.
1 secondary outcome
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.
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 15135594Halliday 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.
- ACST-2 WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Halliday principal investigator
University of Oxford
125 sites in 32 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEA, CAS in people with Carotid Stenosis, run by University of Oxford at 125 sites in 32 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 125 sites in Italy, United Kingdom, Germany, Belgium, Poland and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00883402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.