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

March 23, 2020 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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

3600

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 Contact

Study Contact Backup

Study Locations

  • Austria
      • Innsbruck, Austria
        • Recruiting
        • Medical University of Innsbruck
        • Contact:
          • Gustav Fraedrich, Prof
  • Belgium
      • Antwerp, Belgium
        • Recruiting
        • University Hospital Antwerp
        • Contact:
          • Prof Hendriks
      • Brussels, Belgium
        • Active, not recruiting
        • University St Lucas
      • Dendermonde, Belgium
        • Active, not recruiting
        • Az St Blasius
      • Gent, Belgium
        • Recruiting
        • University Hospital Gent
        • Contact:
          • Frank Vermassen, Professor
      • Liege, Belgium
        • Active, not recruiting
        • Centre Hospitalier Régional de la Citadelle
      • Mouscron, Belgium
        • Active, not recruiting
        • Centre Hospitalier de Mouscron
  • Brazil
      • Sao Paulo, Brazil
        • Recruiting
        • University of Sao Paulo
        • Contact:
          • Erasmo Da Silva, Dr
      • São Paulo, Brazil
        • Recruiting
        • HCFM Ribeirao Preto da Universidade de Sao Paulo
        • Contact:
          • Edwaldo E Joviliano, Dr
  • Bulgaria
      • Varna, Bulgaria
        • Recruiting
        • Sveta Marina Hospital
  • Canada
      • Calgary, Canada
        • Recruiting
        • Foothills Medical Centre
        • Contact:
          • Michael Hill, Dr
  • China
      • Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Ye Zhidong, Dr
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Liu Bao, Professor
  • Croatia
      • Zagreb, Croatia
        • Recruiting
        • University hospital centre Zagreb
        • Contact:
          • Mladen Petrunic, Prof
      • Zagreb, Croatia
        • Recruiting
        • University Hospital of Merkur
        • Contact:
          • Ivan Cvjetko, Dr
  • Czechia
      • Brno, Czechia
        • Recruiting
        • St Anne's University Hospital Brno
        • Contact:
          • Robert Staffa, Prof
      • Liberec, Czechia
        • Recruiting
        • Regional Hospital Liberec
        • Contact:
          • Vladimir Benes, Dr
      • Ostrava Poruba, Czechia
        • Recruiting
        • University Hospital Ostrava Poruba
        • Contact:
          • Dr Prochazka
      • Prague, Czechia
        • Recruiting
        • Central Military Hospital
      • České Budějovice, Czechia
        • Recruiting
        • Hospital České Budějovice
        • Contact:
          • Jiri Fiedler, Dr
  • Egypt
      • Cairo, Egypt
        • Active, not recruiting
        • Kasr Alaini University Hospital
  • Estonia
      • Tallinn, Estonia
        • Recruiting
        • East Tallinn general Hospital
        • Contact:
          • Veronika Palmiste, Dr
  • France
      • Paris, France
        • Recruiting
        • Henri Mondor University Hospital
        • Contact:
          • Jean Pierre Becquemin, Prof
  • Germany
      • Dresden, Germany
        • Recruiting
        • University of Dresden 'Carl-Gustav-Carus'
        • Contact:
          • Jessica Barlinn, Dr
      • Hamburg, Germany
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
        • Contact:
          • Sebastian Debus, prof
      • Jena, Germany
        • Recruiting
        • Universitätsklinik Jena
        • Contact:
          • Albrecht Guenther, Prof
      • Karlsruhe, Germany
        • Recruiting
        • Städtisches Klinikum Karlsruhe
        • Contact:
          • Martin Storck, Prof
      • Leipzig, Germany
        • Recruiting
        • University of Leipzig
        • Contact:
          • Dierk Scheinert, Prof
      • Mannheim, Germany
        • Recruiting
        • Universitätsmedizin Mannheim
        • Contact:
          • Angelika Alonso, Prof
      • Munich, Germany
        • Recruiting
        • Klinikum rechts der Isar derTechnischen Universität Muenchen
        • Contact:
          • Hans Henning Eckstein, Prof
      • Munster, Germany
        • Recruiting
        • St Franziskus-Hospital Münster GmbH
        • Contact:
          • Giovanni Torsello, Prof
      • Singen, Germany
        • Recruiting
        • Hegau-Bodensee-Klinikum
        • Contact:
          • Tomas Pfeiffer, Prof
  • Greece
      • Alexandroupolis, Greece, 68100
        • Recruiting
        • Democritus University of Thrace
        • Contact:
          • Miltos Lazarides, Prof
      • Athens, Greece
        • Recruiting
        • Dept. of Vascular Surgery, Attikon University Hospital
        • Contact:
          • Spyros Vasdekis, Prof
      • Larissa, Greece
        • Recruiting
        • University Hospital Of Larissa
        • Contact:
          • Athanasious Giannoukas, Prof
  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Semmelweis Medical University
        • Contact:
          • Lazslo Entz, Prof
      • Szeged, Hungary
        • Recruiting
        • Albert Szent-Györgyi Medical Centre
        • Contact:
          • Pal Barzo, Prof
  • Ireland
      • Dublin, Ireland
        • Active, not recruiting
        • St. James' Hospital
  • Israel
      • Haifa, Israel
        • Recruiting
        • Rambam Hospital
        • Contact:
          • Prof Hoffman
  • Italy
      • Avellino, Italy
        • Recruiting
        • Azienda Ospedaliera S.G Moscati
        • Contact:
          • giovanni Amatucci, Dr
      • Bari, Italy
        • Recruiting
        • University of Bari
        • Contact:
          • Raffaele Pulli, Prof
      • Bologna, Italy
        • Recruiting
        • University of Bologna
        • Contact:
          • A Stella, Prof
      • Catania, Italy
        • Recruiting
        • Policlinico Catania
        • Contact:
          • P Veroux, Prof
      • Ferrera, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria S.Anna
        • Contact:
          • Vincenzo Gasbarro, Prof
      • Florence, Italy
        • Recruiting
        • San Giovanni Di Dio
        • Contact:
          • S Michelagnoli, Prof
      • Genoa, Italy, 16149
        • Not yet recruiting
        • Opsedale Villa Scassi
        • Contact:
          • Gianantonio Simoni, Dr
          • Phone Number: +39 010 8492870
      • Genoa, Italy
        • Recruiting
        • IRCCS San Martino
        • Contact:
          • D Palombo, Prof
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano
        • Contact:
          • Livio Gabrielli, Prof
      • Milan, Italy
        • Recruiting
        • IRCCS Policlinico San Donato
        • Contact:
          • G Nano, Prof
      • Milan, Italy
        • Recruiting
        • Istituto Auxologico Italiano
        • Contact:
          • Renato Casana, Dr
      • Milan, Italy
        • Active, not recruiting
        • San Paolo Hospital
      • Mirano, Italy
        • Recruiting
        • Mirano Hospital
        • Contact:
          • Salvatore Sacca, Dr
      • Modena, Italy
        • Active, not recruiting
        • Nuovo Ospedale Civile Sant' Agostino Estense
      • Monza, Italy
        • Recruiting
        • Policlinico di Monza
        • Contact:
          • Valerio S Tolva, Dr
      • Nuoro, Italy
        • Active, not recruiting
        • Ospedale San Francesco di Nuoro
      • Palermo, Italy
        • Active, not recruiting
        • University of Palermo
      • Pavia, Italy
        • Active, not recruiting
        • Foundation IRCCS Policlinico San Matteo
      • Perugia, Italy
        • Recruiting
        • Vascular Endovascular Unit of Perugia
        • Contact:
          • Gianbattista Parlani, Dr
      • Raggio, Italy
        • Recruiting
        • Santa Maria Hospital - Reggio
        • Contact:
          • Dr Tusini
      • Roma, Italy, 00128
        • Recruiting
        • Policlinico Universitario Campus Bio-Medico di Roma
        • Contact:
          • Francesco Spinelli, Prof
          • Phone Number: +39 06225411612
      • Rome, Italy
        • Recruiting
        • A.C.O. San Fillippo Neri
        • Contact:
          • Sonia Ronchey, Dr
      • Rome, Italy
        • Not yet recruiting
        • Fondazione Policlinico U. Agostino Gemeli IRCCS
        • Contact:
          • Y Tshomba
      • Rome, Italy
        • Recruiting
        • San Camillo Forlanini
        • Contact:
          • Nicola Mangialardi, Prof
      • Rome, Italy
        • Recruiting
        • University La Sapienza
        • Contact:
          • Francesco Speziale, Prof
      • Rozzano, Italy, 20089
        • Recruiting
        • IRCCS Clinico Humanitas
        • Contact:
          • Efram Civilini, Professor
      • Siena, Italy
        • Recruiting
        • Santa Maria alle Scotte
        • Contact:
          • Prof Setacci
      • Trieste, Italy, 34142
        • Recruiting
        • Ospedali Riuniti di Trieste
        • Contact:
          • Barbara Ziani, Dr
          • Phone Number: +39 040 3994761
      • Turin, Italy
        • Recruiting
        • Umberto I- ASO Mauriziano
        • Contact:
          • M Ferri, Prof
      • Varese, Italy
        • Recruiting
        • Circolo University Hospital
        • Contact:
          • P Castelli, Prof
      • Veneto, Italy
        • Recruiting
        • San Giacomo Hospital
        • Contact:
          • Carlo Cernetti, Dr
    • PA
      • Cefalu, PA, Italy, 90015
        • Recruiting
        • Cefalu Fondazione Istituto G.Giglio
        • Contact:
          • Pierfrancesco Veroux, Prof
  • Japan
      • Sendai, Japan
        • Recruiting
        • Sendai Medical Centre
        • Contact:
          • Inoue Takashi, Dr
  • Kazakhstan
      • Almaty, Kazakhstan
        • Recruiting
        • National Scientific Centre of Surgery
        • Contact:
          • T Tajibayev, Dr
  • Netherlands
      • Arnhem, Netherlands
        • Active, not recruiting
        • Rijnstate Hospital
      • Leeuwarden, Netherlands
        • Recruiting
        • MCL Leeuwarden
        • Contact:
          • A. Khodadade Jahrome, Dr
      • Utrecht, Netherlands
        • Recruiting
        • University Hospital Utrecht
        • Contact:
          • GJ de Borst, Dr
  • Norway
      • Oslo, Norway
        • Active, not recruiting
        • Rikshospitalet
  • Poland
      • Poznan, Poland
        • Recruiting
        • Poznan University of Medical Sciences
        • Contact:
          • G Oszkinis, Prof
      • Warsaw, Poland
        • Recruiting
        • Bielanski Hospital
        • Contact:
          • G Madycki, Professor
      • Warsaw, Poland
        • Active, not recruiting
        • Central Hospital Internal Aff.
      • Warsaw, Poland
        • Recruiting
        • Mazovian Brodnowski Hospital
        • Contact:
          • P Myrcha, Ass. Prof
      • Warsaw, Poland
        • Recruiting
        • University of Warsaw/ Institute of Psychiatry
        • Contact:
          • Dr Kobayashi
      • Wroclaw, Poland
        • Recruiting
        • Regional Specialist Hospital (Wroclaw)
        • Contact:
          • W Iwanowski, Dr
  • Portugal
      • Lisbon, Portugal, 1150
        • Active, not recruiting
        • Hospital Santa Marta
  • Russian Federation
      • Novosibirsk, Russian Federation
        • Recruiting
        • Novosibirsk research institute of circulation pathology
        • Contact:
          • V Starodubtsev, Dr
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Saint Petersburg Scientific Research Institute for Emergency Care
        • Contact:
          • Pavel Chechulov, Dr
      • Saint Petersburg, Russian Federation
        • Recruiting
        • V.A. Almazov National Medical Research Centre
        • Contact:
          • Boris Komakha, Dr
  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • Dedinje Cardiovascular Unit
        • Contact:
          • G Radak, Prof
      • Belgrade, Serbia
        • Recruiting
        • Serbian Clinical Centre
        • Contact:
          • L Davidovic, Prof
  • Singapore
      • Singapore, Singapore
        • Withdrawn
        • Khoo Teck Puat Hospital
  • Slovakia
      • Ruzomberok, Slovakia
        • Active, not recruiting
        • Institute of Medical Sciences
  • Slovenia
      • Izola, Slovenia
        • Recruiting
        • Izola General Hospital
        • Contact:
          • M Gasparini, Prof
      • Maribor, Slovenia
        • Recruiting
        • Teaching Hospital Maribor
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic 1 Provinical de Barcelona
        • Contact:
          • Dr Riambau
      • Guadalajara, Spain
        • Recruiting
        • Guadalajara Hospital
        • Contact:
          • Estrella Blanco, Dr
      • Valencia, Spain
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
          • Manuel Miralles, Dr
  • Sweden
      • Helsingborg, Sweden
        • Recruiting
        • Lasarettet Helsingborg
        • Contact:
          • P Qvarfordt, Prof
      • Malmo, Sweden
        • Recruiting
        • Malmö University Hospital
        • Contact:
          • Dr Bjores
      • Stockholm, Sweden
        • Recruiting
        • Södersjukhuset
        • Contact:
          • Dr Konrad
  • Switzerland
      • Aarau, Switzerland, CH-5001
        • Recruiting
        • Cantonal Hospital Aarau
        • Contact:
          • Timo Kahles, Dr
      • Basel, Switzerland
        • Recruiting
        • University of Basel
        • Contact:
          • Leo Bonati, Dr
  • United Kingdom
      • Aintree, United Kingdom
        • Active, not recruiting
        • Walton Centre
      • Cheltenham, United Kingdom
        • Recruiting
        • Cheltenham General Hospital
        • Contact:
          • Richard Bulbulia, Mr
      • Durham, United Kingdom
        • Active, not recruiting
        • Bishop Auckland Hospital
      • Durham, United Kingdom
        • Active, not recruiting
        • University Hospital of North Durham
      • Hull, United Kingdom
        • Recruiting
        • Hull Royal Infirmary
        • Contact:
          • Ian Chetter, Prof
      • London, United Kingdom
        • Active, not recruiting
        • St George's Hospital
      • London, United Kingdom
        • Recruiting
        • The Royal London
        • Contact:
          • Sageet Amlani, Dr
      • Luton, United Kingdom
        • Recruiting
        • Luton & Dunstable Hospital
        • Contact:
          • L Sekaran, Dr
      • Manchester, United Kingdom
        • Recruiting
        • Manchester Royal Infirmary
        • Contact:
          • JV Smyth, Mr
      • Manchester, United Kingdom
        • Recruiting
        • Wythenshawe Hospital
        • Contact:
          • C McCollum, Prof
      • Middlesbrough, United Kingdom
        • Active, not recruiting
        • James Cook Hospital
      • Newcastle, United Kingdom
        • Recruiting
        • Freeman Hospital
        • Contact:
          • Gerry Stansby, Prof
      • Newcastle, United Kingdom
        • Active, not recruiting
        • Royal Victoria Infirmary
      • Nottingham, United Kingdom
        • Recruiting
        • Nottingham University Hospital
        • Contact:
          • S Mac Sweeney, Mr
      • Oxford, United Kingdom
        • Recruiting
        • John Radcliffe Hospital
        • Contact:
          • Ursula Schulz, Dr
      • Plymouth, United Kingdom
        • Active, not recruiting
        • Derriford Hospital
      • Preston, United Kingdom
        • Recruiting
        • The Royal Preston Hospital
        • Contact:
          • George Thomas, Mr
      • Reading, United Kingdom
        • Recruiting
        • Royal Berkshire
        • Contact:
          • E Flossman, Dr
      • Sheffield, United Kingdom
        • Recruiting
        • Sheffield Vascular Institute
        • Contact:
          • Trevor Cleveland, Dr
      • Sunderland, United Kingdom
        • Recruiting
        • Sunderland Royal Hospital
        • Contact:
          • P Dunlop, Mr
      • Swindon, United Kingdom
        • Recruiting
        • Great Western Hospital
        • Contact:
          • Gopi Ramadurai, Dr
      • Whitehaven, United Kingdom
        • Active, not recruiting
        • North Cumbria University Hospital
      • York, United Kingdom
        • Withdrawn
        • York Hospital
    • Essex
      • Westcliff-on-Sea, Essex, United Kingdom
        • Recruiting
        • Southend University Hospital
        • Contact:
          • P Guyler, Dr
    • Kent
      • Canterbury, Kent, United Kingdom
        • Recruiting
        • East Kent Hospitals University NHS Foundation Trust
        • Contact:
          • David Hargroves, Dr
  • United States
    • Ohio
      • Toledo, Ohio, United States, 43614
        • Active, not recruiting
        • 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
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
10 years

Secondary Outcome Measures

Outcome Measure
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
10 years

Collaborators and Investigators

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

Sponsor

University of Oxford

Collaborators

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 (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 15, 2009

First Submitted That Met QC Criteria

April 15, 2009

First Posted (Estimate)

April 17, 2009

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

April 1, 2019

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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