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

This study is currently recruiting participants.
Verified June 2017 by University of Oxford
Sponsor:
ClinicalTrials.gov Identifier:
NCT00883402
First Posted: April 17, 2009
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
NHS Health Technology Assessment Programme
BUPA Foundation
Information provided by (Responsible Party):
University of Oxford
  Purpose

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


Condition Intervention
Carotid Stenosis Procedure: CEA, CAS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Asymptomatic Carotid Surgery Trial-2 (ACST-2): an International Randomised Trial to Compare Carotid Endarterectomy With Carotid Artery Stenting to Prevent Stroke

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3600
Study Start Date: January 2008
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883402


Contacts
Contact: Alison Halliday + 44 1865 221 345 acst@nds.ox.ac.uk
Contact: Alison Clarke + 44 1865 617979 acst@nds.ox.ac.uk

  Hide Study Locations
Locations
United States, Ohio
University of Toledo Medical Centre Active, not recruiting
Toledo, Ohio, United States, 43614
Belgium
University Hospital Antwerp Recruiting
Antwerp, Belgium
Contact: Prof Hendriks         
University St Lucas Active, not recruiting
Brussels, Belgium
Az St Blasius Active, not recruiting
Dendermonde, Belgium
University Hospital Gent Recruiting
Gent, Belgium
Contact: Frank Vermassen, Professor         
Centre Hospitalier Régional de la Citadelle Active, not recruiting
Liege, Belgium
Centre Hospitalier De Mouscron Active, not recruiting
Mouscron, Belgium
Brazil
University of Sao Paulo Recruiting
Sao Paulo, Brazil
Contact: Erasmo Da Silva, Dr         
Bulgaria
Sveta Marina Hospital Recruiting
Varna, Bulgaria
Canada
Foothills Medical Centre Recruiting
Calgary, Canada
Contact: Michael Hill, Dr         
China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Liu Bao, Professor         
Croatia
University Hospital of Merkur Recruiting
Zagreb, Croatia
Contact: Ivan Cvjetko, Dr         
Czechia
St Anne's University Hospital Brno Recruiting
Brno, Czechia
Contact: Robert Staffa, Prof         
Hospital Ceské Budejovice Recruiting
Budejovice, Czechia
Contact: Jiri Fiedler, Dr         
Regional Hospital Liberec Recruiting
Liberec, Czechia
Contact: Vladimir Benes, Dr         
University Hospital Ostrava Poruba Recruiting
Ostrava Poruba, Czechia
Contact: Dr Prochazka         
Central Military Hospital Recruiting
Prague, Czechia
Egypt
Kasr Alaini University Hospital Active, not recruiting
Cairo, Egypt
Estonia
East Tallinn general Hospital Recruiting
Tallinn, Estonia
Contact: Veronika Palmiste, Dr         
Germany
University of Dresden 'Carl-Gustav-Carus' Recruiting
Dresden, Germany
Contact: Jessica Barlinn, Dr         
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany
Contact: Sebastian Debus, prof         
Universitätsklinik Jena Recruiting
Jena, Germany
Contact: Albrecht Guenther, Prof         
Städtisches Klinikum Karlsruhe Recruiting
Karlsruhe, Germany
Contact: Martin Storck, Prof         
University of Leipzig Recruiting
Leipzig, Germany
Contact: Dierk Scheinert, Prof         
Klinikum rechts der Isar derTechnischen Universität Muenchen Recruiting
Munich, Germany
Contact: Hans Henning Eckstein, Prof         
St Franziskus-Hospital Münster GmbH Recruiting
Munster, Germany
Contact: Giovanni Torsello, Prof         
Hegau-Bodensee-Klinikum Recruiting
Singen, Germany
Contact: Tomas Pfeiffer, Prof         
Greece
Democritus University of Thrace Recruiting
Alexandroupolis, Greece, 68100
Contact: Miltos Lazarides, Prof         
Dept. of Vascular Surgery, Attikon University Hospital Recruiting
Athens, Greece
Contact: Spyros Vasdekis, Prof         
University Hospital of Larissa Recruiting
Larissa, Greece
Contact: Athanasious Giannoukas, Prof         
Hungary
Semmelweis Medical University Recruiting
Budapest, Hungary
Contact: Lazslo Entz, Prof         
Albert Szent-Györgyi Medical Centre Recruiting
Szeged, Hungary
Contact: Pal Barzo, Prof         
Ireland
St. James' Hospital Active, not recruiting
Dublin, Ireland
Israel
Rambam Hospital Recruiting
Haifa, Israel
Contact: Prof Hoffman         
Italy
Cefalu Fondazione Istituto G.Giglio Recruiting
Cefalu, PA, Italy, 90015
Contact: Pierfrancesco Veroux, Prof         
Azienda Ospedaliera S.G Moscati Recruiting
Avelino, Italy
Contact: giovanni Amatucci, Dr         
University of Bari Recruiting
Bari, Italy
Contact: D Angiletta, Prof         
University of Bologna Recruiting
Bologna, Italy
Contact: A Stella, Prof         
Policlinico Catania Recruiting
Catania, Italy
Contact: P Veroux, Prof         
Azienda Ospedaliero-Universitaria S.Anna Recruiting
Ferrera, Italy
Contact: Francesco Mascoli, Prof         
San Giovanni Di Dio Recruiting
Florence, Italy
Contact: S Michelagnoli, Prof         
Opsedale Villa Scassi Not yet recruiting
Genoa, Italy, 16149
Contact: Gianantonio Simoni, Dr    +39 010 8492870      
IRCCS San Martino Recruiting
Genoa, Italy
Contact: D Palombo, Prof         
IRCCS Policlinico San Donato Recruiting
Milan, Italy
Contact: G Nano, Prof         
Istituto Auxologico Italiano Recruiting
Milan, Italy
Contact: Renato Casana, Dr         
San Paolo Hospital Active, not recruiting
Milan, Italy
Mirano Hospital Recruiting
Mirano, Italy
Contact: B Reimers, Dr         
Nuovo Ospedale Civile Sant' Agostino Estense Recruiting
Modena, Italy
Contact: G Coppi, Prof         
Ospedale San Francesco di Nuoro Recruiting
Nuoro, Italy
Contact: Franco Fadda, Prof         
University of Palermo Active, not recruiting
Palermo, Italy
Foundation IRCCS Policlinico San Matteo Active, not recruiting
Pavia, Italy
Vascular Endovascular Unit of Perugia Recruiting
Perugia, Italy
Contact: Fabio Verzini, Prof         
Santa Maria Hospital - Reggio Recruiting
Raggio, Italy
Contact: Dr Tusini         
Policlinico Universitario Campus Bio-medico di Roma Recruiting
Roma, Italy, 00128
Contact: Francesco Spinelli, Prof    +39 06225411612      
A.C.O. San Fillippo Neri Recruiting
Rome, Italy
Contact: N Mangialardi, Prof         
San Camillo Forlanini Recruiting
Rome, Italy
Contact: P Cao, Prof         
University La Sapienza Recruiting
Rome, Italy
Contact: Dr Speziale         
IRCCS Clinico Humanitas Recruiting
Rozzano, Italy, 20089
Contact: Efram Civilini, Professor         
Santa Maria alle Scotte Recruiting
Siena, Italy
Contact: Prof Setacci         
Ospedali Riuniti di Trieste Recruiting
Trieste, Italy, 34142
Contact: Barbara Ziani, Dr    +39 040 3994761      
Umberto I- ASO Mauriziano Recruiting
Turin, Italy
Contact: M Ferri, Prof         
Circolo University Hospital Recruiting
Varese, Italy
Contact: P Castelli, Prof         
San Giacomo Hospital Recruiting
Veneto, Italy
Contact: Carlo Cernetti, Dr         
Japan
Sendai Medical Centre Recruiting
Sendai, Japan
Contact: Inoue Takashi, Dr         
Kazakhstan
National Scientific Centre of Surgery Active, not recruiting
Almaty, Kazakhstan
Netherlands
Rijnstate Hospital Active, not recruiting
Arnhem, Netherlands
MCL Leeuwarden Recruiting
Leeuwarden, Netherlands
Contact: A. Khodadade Jahrome, Dr         
University Hospital Utrecht Recruiting
Utrecht, Netherlands
Contact: GJ de Borst, Dr         
Norway
Rikshospitalet Active, not recruiting
Oslo, Norway
Poland
Poznan University of Medical Sciences Recruiting
Poznan, Poland
Contact: G Oszkinis, Prof         
Central Hospital Internal Aff. Active, not recruiting
Warsaw, Poland
University of Warsaw/ Institute of Psychiatry Recruiting
Warsaw, Poland
Contact: Dr Kobayashi         
Regional Specialist Hospital (Wroclaw) Recruiting
Wroclaw, Poland
Contact: W Iwanowski, Dr         
Portugal
Hospital Santa Marta Recruiting
Lisbon, Portugal, 1150
Contact: Frederico Bastos Goncalves, Prof         
Russian Federation
Novosibirsk Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation
Contact: V Starodubtsev, Dr         
Serbia
Dedinje Cardiovascular Unit Recruiting
Belgrade, Serbia
Contact: G Radak, Prof         
Serbian Clinical Centre Recruiting
Belgrade, Serbia
Contact: L Davidovic, Prof         
Slovakia
Institute of Medical Sciences Active, not recruiting
Ruzomberok, Slovakia
Slovenia
Izola General Hospital Recruiting
Izola, Slovenia
Contact: M Gasparini, Prof         
Teaching Hospital Maribor Recruiting
Maribor, Slovenia
Spain
Hospital Clinic 1 Provinical de Barcelona Recruiting
Barcelona, Spain
Contact: Dr Riambau         
Guadalajara Hospital Recruiting
Guadalajara, Spain
Contact: Estrella Blanco, Dr         
Sweden
Lasarettet Helsingborg Recruiting
Helsingborg, Sweden
Contact: P Qvarfordt, Prof         
Malmo University Hospital Recruiting
Malmo, Sweden
Contact: Dr Bjores         
Sodersjukhuset Recruiting
Stockholm, Sweden
Contact: Dr Konrad         
Switzerland
Cantonal Hospital Aarau Recruiting
Aarau, Switzerland, CH-5001
Contact: Timo Kahles, Dr         
University of Basel Recruiting
Basel, Switzerland
Contact: Leo Bonati, Dr         
United Kingdom
Walton Centre Active, not recruiting
Aintree, United Kingdom
Cheltenham General Hospital Recruiting
Cheltenham, United Kingdom
Contact: Richard Bulbulia, Mr         
Bishop Auckland Hospital Recruiting
Durham, United Kingdom
Contact: Dr Mehrzad         
University Hospital of North Durham Active, not recruiting
Durham, United Kingdom
Southend University Hospital Recruiting
Essex, United Kingdom
Contact: P Guyler, Dr         
Hull Royal Infirmary Recruiting
Hull, United Kingdom
Contact: Ian Chetter, Prof         
East Kent Hospitals University NHS Foundation Trust Recruiting
Kent, United Kingdom
Contact: David Hargroves, Dr         
The Royal London Recruiting
London, United Kingdom
Contact: Raj Yadava, Dr         
Luton & Dunstable Hospital Recruiting
Luton, United Kingdom
Contact: L Sekaran, Dr         
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom
Contact: JV Smyth, Mr         
Wythenshawe Hospital Recruiting
Manchester, United Kingdom
Contact: C McCollum, Prof         
James Cook Hospital Active, not recruiting
Middlesbrough, United Kingdom
Freeman Hospital Recruiting
Newcastle, United Kingdom
Contact: Gerry Stansby, Prof         
Royal Victoria Infirmary Active, not recruiting
Newcastle, United Kingdom
Nottingham University Hospital Recruiting
Nottingham, United Kingdom
Contact: S Mac Sweeney, Mr         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom
Contact: Ursula Schulz, Dr         
Derriford Hospital Active, not recruiting
Plymouth, United Kingdom
The Royal Preston Hospital Recruiting
Preston, United Kingdom
Contact: George Thomas, Mr         
Royal Berkshire Recruiting
Reading, United Kingdom
Contact: E Flossman, Dr         
Sheffield Vascular Institute Recruiting
Sheffield, United Kingdom
Contact: Trevor Cleveland, Dr         
Sunderland Royal Hospital Recruiting
Sunderland, United Kingdom
Contact: P Dunlop, Mr         
Great Western Hospital Recruiting
Swindon, United Kingdom
Contact: Gopi Ramadurai, Dr         
North Cumbria University Hospital Active, not recruiting
Whitehaven, United Kingdom
York Hospital Recruiting
York, United Kingdom
Contact: Andrew Thompson, Mr         
Sponsors and Collaborators
University of Oxford
NHS Health Technology Assessment Programme
BUPA Foundation
Investigators
Principal Investigator: Alison Halliday University of Oxford
  More Information

Additional Information:
Publications:
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT00883402     History of Changes
Other Study ID Numbers: ACST-2
First Submitted: April 15, 2009
First Posted: April 17, 2009
Last Update Posted: June 14, 2017
Last Verified: June 2017

Keywords provided by University of Oxford:
Carotid stenosis
CEA
CAS
Stenting

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases