Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients (ACST-2)

December 4, 2024 updated by: University of Oxford

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3638

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Medical University of Innsbruck
  • Belgium
      • Antwerp, Belgium
        • University Hospital Antwerp
      • Brussels, Belgium
        • University St Lucas
      • Dendermonde, Belgium
        • Az St Blasius
      • Gent, Belgium
        • University Hospital Gent
      • Liege, Belgium
        • Centre Hospitalier Régional de la Citadelle
      • Mouscron, Belgium
        • Centre Hospitalier De Mouscron
  • Brazil
      • Sao Paulo, Brazil
        • University of Sao Paulo
      • São Paulo, Brazil
        • HCFM Ribeirao Preto da Universidade de Sao Paulo
  • Bulgaria
      • Varna, Bulgaria
        • Sveta Marina Hospital
  • Canada
      • Calgary, Canada
        • Foothills Medical Centre
  • China
      • Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, China
        • China-Japan Friendship Hospital
  • Croatia
      • Zagreb, Croatia
        • University hospital centre Zagreb
      • Zagreb, Croatia
        • University Hospital of Merkur
  • Czechia
      • Brno, Czechia
        • St Anne's University Hospital Brno
      • Liberec, Czechia
        • Regional Hospital Liberec
      • Ostrava Poruba, Czechia
        • University Hospital Ostrava Poruba
      • Prague, Czechia
        • Central Military Hospital
      • České Budějovice, Czechia
        • Hospital Ceské Budejovice
  • Egypt
      • Cairo, Egypt
        • Kasr Alaini University Hospital
  • Estonia
      • Tallinn, Estonia
        • East Tallinn general Hospital
  • France
      • Paris, France
        • Henri Mondor University Hospital
  • Germany
      • Dresden, Germany
        • University of Dresden 'Carl-Gustav-Carus'
      • Hamburg, Germany
        • Universitätsklinikum Hamburg-Eppendorf
      • Jena, Germany
        • Universitätsklinik Jena
      • Karlsruhe, Germany
        • Stadtisches Klinikum Karlsruhe
      • Leipzig, Germany
        • University of Leipzig
      • Mannheim, Germany
        • Universitätsmedizin Mannheim
      • Munich, Germany
        • Klinikum rechts der Isar derTechnischen Universität Muenchen
      • Munster, Germany
        • St Franziskus-Hospital Münster GmbH
      • Singen, Germany
        • Hegau-Bodensee-Klinikum
  • Greece
      • Alexandroupolis, Greece, 68100
        • Democritus University of Thrace
      • Athens, Greece
        • Dept. of Vascular Surgery, Attikon University Hospital
      • Larissa, Greece
        • University Hospital of Larissa
  • Hungary
      • Budapest, Hungary
        • Semmelweis Medical University
      • Szeged, Hungary
        • Albert Szent-Györgyi Medical Centre
  • Ireland
      • Dublin, Ireland
        • St. James' Hospital
  • Israel
      • Haifa, Israel
        • Rambam Hospital
  • Italy
      • Avellino, Italy
        • Azienda Ospedaliera S.G Moscati
      • Bari, Italy
        • University of Bari
      • Bologna, Italy
        • University of Bologna
      • Catania, Italy
        • Policlinico Catania
      • Ferrera, Italy
        • Azienda Ospedaliero-Universitaria S.Anna
      • Florence, Italy
        • San Giovanni Di Dio
      • Genoa, Italy, 16149
        • Opsedale Villa Scassi
      • Genoa, Italy
        • IRCCS San Martino
      • Milan, Italy
        • San Paolo Hospital
      • Milan, Italy
        • IRCCS Policlinico San Donato
      • Milan, Italy
        • Istituto Auxologico Italiano
      • Milan, Italy
        • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano
      • Mirano, Italy
        • Mirano Hospital
      • Modena, Italy
        • Nuovo Ospedale Civile Sant' Agostino Estense
      • Monza, Italy
        • Policlinico di Monza
      • Nuoro, Italy
        • Ospedale San Francesco di Nuoro
      • Palermo, Italy
        • University of Palermo
      • Pavia, Italy
        • Foundation IRCCS Policlinico San Matteo
      • Perugia, Italy
        • Vascular Endovascular Unit of Perugia
      • Raggio, Italy
        • Santa Maria Hospital - Reggio
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico di Roma
      • Rome, 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
      • Rozzano, Italy, 20089
        • IRCCS Clinico Humanitas
      • Siena, Italy
        • Santa Maria alle Scotte
      • Trieste, Italy, 34142
        • Ospedali Riuniti di Trieste
      • Turin, Italy
        • Umberto I- ASO Mauriziano
      • Varese, Italy
        • Circolo University Hospital
      • Veneto, Italy
        • San Giacomo Hospital
    • PA
      • Cefalu, PA, Italy, 90015
        • Cefalu Fondazione Istituto G.Giglio
  • Japan
      • Sendai, Japan
        • Sendai Medical Centre
  • Kazakhstan
      • Almaty, Kazakhstan
        • National Scientific Centre of Surgery
  • Netherlands
      • Arnhem, Netherlands
        • Rijnstate Hospital
      • Leeuwarden, Netherlands
        • MCL Leeuwarden
      • Utrecht, Netherlands
        • University Hospital Utrecht
  • Norway
      • Oslo, Norway
        • Rikshospitalet
  • Poland
      • Poznan, Poland
        • Poznan University of Medical Sciences
      • Warsaw, Poland
        • Bielanski Hospital
      • Warsaw, Poland
        • Central Hospital Internal Aff.
      • Warsaw, Poland
        • Mazovian Brodnowski Hospital
      • Warsaw, Poland
        • University of Warsaw/ Institute of Psychiatry
      • Wroclaw, Poland
        • Regional Specialist Hospital (Wroclaw)
  • Portugal
      • Lisbon, Portugal, 1150
        • Hospital Santa Marta
  • Russian Federation
      • Novosibirsk, Russian Federation
        • Novosibirsk Research Institute of Circulation Pathology
      • Saint Petersburg, Russian Federation
        • Saint Petersburg Scientific Research Institute for Emergency Care
      • Saint Petersburg, Russian Federation
        • V.A. Almazov National Medical Research Centre
  • Serbia
      • Belgrade, Serbia
        • Dedinje Cardiovascular Unit
      • Belgrade, Serbia
        • Serbian Clinical Centre
  • Slovakia
      • Ruzomberok, Slovakia
        • Institute of Medical Sciences
  • Slovenia
      • Izola, Slovenia
        • Izola General Hospital
      • Maribor, Slovenia
        • Teaching Hospital Maribor
  • Spain
      • Barcelona, Spain
        • Hospital Clinic 1 Provinical de Barcelona
      • Guadalajara, Spain
        • Guadalajara Hospital
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe
  • Sweden
      • Helsingborg, Sweden
        • Lasarettet Helsingborg
      • Malmo, Sweden
        • Malmo University Hospital
      • Stockholm, Sweden
        • Södersjukhuset
  • Switzerland
      • Aarau, Switzerland, CH-5001
        • Cantonal Hospital Aarau
      • Basel, Switzerland
        • University of Basel
  • United Kingdom
      • Aintree, United Kingdom
        • Walton Centre
      • Cheltenham, United Kingdom
        • Cheltenham General Hospital
      • Durham, United Kingdom
        • University Hospital of North Durham
      • Durham, United Kingdom
        • Bishop Auckland Hospital
      • Hull, United Kingdom
        • Hull Royal Infirmary
      • London, United Kingdom
        • St George's Hospital
      • London, United Kingdom
        • The Royal London
      • Luton, United Kingdom
        • Luton & Dunstable Hospital
      • Manchester, United Kingdom
        • Manchester Royal Infirmary
      • Manchester, United Kingdom
        • Wythenshawe Hospital
      • Middlesbrough, United Kingdom
        • James Cook Hospital
      • Newcastle, United Kingdom
        • Royal Victoria Infirmary
      • Newcastle, United Kingdom
        • Freeman Hospital
      • Nottingham, United Kingdom
        • Nottingham University Hospital
      • Oxford, United Kingdom
        • John Radcliffe Hospital
      • Plymouth, United Kingdom
        • Derriford Hospital
      • Preston, United Kingdom
        • The Royal Preston Hospital
      • Reading, United Kingdom
        • Royal Berkshire
      • Sheffield, United Kingdom
        • Sheffield Vascular Institute
      • Sunderland, United Kingdom
        • Sunderland Royal Hospital
      • Swindon, United Kingdom
        • Great Western Hospital
      • Whitehaven, United Kingdom
        • North Cumbria University Hospital
    • Essex
      • Westcliff-on-Sea, Essex, United Kingdom
        • Southend University Hospital
    • Kent
      • Canterbury, Kent, United Kingdom
        • East Kent Hospitals University NHS Foundation Trust
  • United States
    • Ohio
      • Toledo, Ohio, United States, 43614
        • University of Toledo Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CEA
Carotid endarterectomy
Procedure: CEA, CAS
Carotid Artery Stenting (CAS) Carotid endarterectomy (CEA)
Active Comparator: CAS
Carotid Artery Stenting
Procedure: CEA, CAS
Carotid Artery Stenting (CAS) Carotid endarterectomy (CEA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

British Heart Foundation
NHS Health Technology Assessment Programme
BUPA Foundation

Investigators

  • Principal Investigator: Alison Halliday, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2020

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 15, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (Estimated)

April 17, 2009

Study Record Updates

Last Update Posted (Actual)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACST-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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