Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients

NCT ID: NCT00883402

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

3638 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Carotid Stenosis

Keywords

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Carotid stenosis CEA CAS Stenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CEA

Carotid endarterectomy

Group Type ACTIVE_COMPARATOR

CEA, CAS

Intervention Type PROCEDURE

Carotid Artery Stenting (CAS) Carotid endarterectomy (CEA)

CAS

Carotid Artery Stenting

Group Type ACTIVE_COMPARATOR

CEA, CAS

Intervention Type PROCEDURE

Carotid Artery Stenting (CAS) Carotid endarterectomy (CEA)

Interventions

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CEA, CAS

Carotid Artery Stenting (CAS) Carotid endarterectomy (CEA)

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Health Technology Assessment Programme

OTHER

Sponsor Role collaborator

BUPA Foundation

OTHER

Sponsor Role collaborator

British Heart Foundation

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alison Halliday

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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University of Toledo Medical Centre

Toledo, Ohio, United States

Site Status

Medical University of Innsbruck

Innsbruck, , Austria

Site Status

University Hospital Antwerp

Antwerp, , Belgium

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University St Lucas

Brussels, , Belgium

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Az St Blasius

Dendermonde, , Belgium

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University Hospital Gent

Ghent, , Belgium

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Centre Hospitalier Régional de la Citadelle

Liège, , Belgium

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Centre Hospitalier De Mouscron

Mouscron, , Belgium

Site Status

HCFM Ribeirao Preto da Universidade de Sao Paulo

São Paulo, , Brazil

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University of Sao Paulo

São Paulo, , Brazil

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Sveta Marina Hospital

Varna, , Bulgaria

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Foothills Medical Centre

Calgary, , Canada

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China-Japan Friendship Hospital

Beijing, , China

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Peking Union Medical College Hospital

Beijing, , China

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University Hospital Centre Zagreb

Zagreb, , Croatia

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University Hospital of Merkur

Zagreb, , Croatia

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St Anne's University Hospital Brno

Brno, , Czechia

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Hospital Ceské Budejovice

České Budějovice, , Czechia

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Regional Hospital Liberec

Liberec, , Czechia

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University Hospital Ostrava Poruba

Ostrava Poruba, , Czechia

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Central Military Hospital

Prague, , Czechia

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Kasr Alaini University Hospital

Cairo, , Egypt

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East Tallinn general Hospital

Tallinn, , Estonia

Site Status

Henri Mondor University Hospital

Paris, , France

Site Status

University of Dresden 'Carl-Gustav-Carus'

Dresden, , Germany

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Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

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Universitätsklinik Jena

Jena, , Germany

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Städtisches Klinikum Karlsruhe

Karlsruhe, , Germany

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University of Leipzig

Leipzig, , Germany

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Universitätsmedizin Mannheim

Mannheim, , Germany

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Klinikum rechts der Isar derTechnischen Universität Muenchen

Munich, , Germany

Site Status

St Franziskus-Hospital Münster GmbH

Münster, , Germany

Site Status

Hegau-Bodensee-Klinikum

Singen, , Germany

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Democritus University of Thrace

Alexandroupoli, , Greece

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Dept. of Vascular Surgery, Attikon University Hospital

Athens, , Greece

Site Status

University Hospital of Larissa

Larissa, , Greece

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Semmelweis Medical University

Budapest, , Hungary

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Albert Szent-Györgyi Medical Centre

Szeged, , Hungary

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St. James' Hospital

Dublin, , Ireland

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Rambam Hospital

Haifa, , Israel

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Cefalu Fondazione Istituto G.Giglio

Cefalù, PA, Italy

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Azienda Ospedaliera S.G Moscati

Avellino, , Italy

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University of Bari

Bari, , Italy

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University of Bologna

Bologna, , Italy

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Policlinico Catania

Catania, , Italy

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Azienda Ospedaliero-Universitaria S.Anna

Ferrera, , Italy

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San Giovanni Di Dio

Florence, , Italy

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Opsedale Villa Scassi

Genoa, , Italy

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IRCCS San Martino

Genoa, , Italy

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Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano

Milan, , Italy

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IRCCS Policlinico San Donato

Milan, , Italy

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Istituto Auxologico Italiano

Milan, , Italy

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San Paolo Hospital

Milan, , Italy

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Mirano Hospital

Mirano, , Italy

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Nuovo Ospedale Civile Sant' Agostino Estense

Modena, , Italy

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Policlinico di Monza

Monza, , Italy

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Ospedale San Francesco di Nuoro

Nuoro, , Italy

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University of Palermo

Palermo, , Italy

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Foundation IRCCS Policlinico San Matteo

Pavia, , Italy

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Vascular Endovascular Unit of Perugia

Perugia, , Italy

Site Status

Santa Maria Hospital - Reggio

Raggio, , Italy

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Policlinico Universitario Campus Bio-medico di Roma

Roma, , Italy

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A.C.O. San Fillippo Neri

Rome, , Italy

Site Status

Fondazione Policlinico U. Agostino Gemeli IRCCS

Rome, , Italy

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San Camillo Forlanini

Rome, , Italy

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University La Sapienza

Rome, , Italy

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IRCCS Clinico Humanitas

Rozzano, , Italy

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Santa Maria alle Scotte

Siena, , Italy

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Ospedali Riuniti di Trieste

Trieste, , Italy

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Umberto I- ASO Mauriziano

Turin, , Italy

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Circolo University Hospital

Varese, , Italy

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San Giacomo Hospital

Veneto, , Italy

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Sendai Medical Centre

Sendai, , Japan

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National Scientific Centre of Surgery

Almaty, , Kazakhstan

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Rijnstate Hospital

Arnhem, , Netherlands

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MCL Leeuwarden

Leeuwarden, , Netherlands

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University Hospital Utrecht

Utrecht, , Netherlands

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Rikshospitalet

Oslo, , Norway

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Poznan University of Medical Sciences

Poznan, , Poland

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Bielanski Hospital

Warsaw, , Poland

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Central Hospital Internal Aff.

Warsaw, , Poland

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Mazovian Brodnowski Hospital

Warsaw, , Poland

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University of Warsaw/ Institute of Psychiatry

Warsaw, , Poland

Site Status

Regional Specialist Hospital (Wroclaw)

Wroclaw, , Poland

Site Status

Hospital Santa Marta

Lisbon, , Portugal

Site Status

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status

Saint Petersburg Scientific Research Institute for Emergency Care

Saint Petersburg, , Russia

Site Status

V.A. Almazov National Medical Research Centre

Saint Petersburg, , Russia

Site Status

Dedinje Cardiovascular Unit

Belgrade, , Serbia

Site Status

Serbian Clinical Centre

Belgrade, , Serbia

Site Status

Institute of Medical Sciences

Ružomberok, , Slovakia

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Izola General Hospital

Izola, , Slovenia

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Teaching Hospital Maribor

Maribor, , Slovenia

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Hospital Clinic 1 Provinical de Barcelona

Barcelona, , Spain

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Guadalajara Hospital

Guadalajara, , Spain

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Hospital Universitari I Politecnic La Fe

Valencia, , Spain

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Lasarettet Helsingborg

Helsingborg, , Sweden

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Malmo University Hospital

Malmo, , Sweden

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Sodersjukhuset

Stockholm, , Sweden

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Cantonal Hospital Aarau

Aarau, , Switzerland

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University of Basel

Basel, , Switzerland

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Southend University Hospital

Westcliff-on-Sea, Essex, United Kingdom

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East Kent Hospitals University NHS Foundation Trust

Canterbury, Kent, United Kingdom

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Walton Centre

Aintree, , United Kingdom

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Cheltenham General Hospital

Cheltenham, , United Kingdom

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Bishop Auckland Hospital

Durham, , United Kingdom

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University Hospital of North Durham

Durham, , United Kingdom

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Hull Royal Infirmary

Hull, , United Kingdom

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St George's Hospital

London, , United Kingdom

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The Royal London

London, , United Kingdom

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Luton & Dunstable Hospital

Luton, , United Kingdom

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Manchester Royal Infirmary

Manchester, , United Kingdom

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Wythenshawe Hospital

Manchester, , United Kingdom

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James Cook Hospital

Middlesbrough, , United Kingdom

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Freeman Hospital

Newcastle, , United Kingdom

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Royal Victoria Infirmary

Newcastle, , United Kingdom

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Nottingham University Hospital

Nottingham, , United Kingdom

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John Radcliffe Hospital

Oxford, , United Kingdom

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Derriford Hospital

Plymouth, , United Kingdom

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The Royal Preston Hospital

Preston, , United Kingdom

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Royal Berkshire

Reading, , United Kingdom

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Sheffield Vascular Institute

Sheffield, , United Kingdom

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Sunderland Royal Hospital

Sunderland, , United Kingdom

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Great Western Hospital

Swindon, , United Kingdom

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North Cumbria University Hospital

Whitehaven, , United Kingdom

Site Status

Countries

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Singapore United States Austria Belgium Brazil Bulgaria Canada China Croatia Czechia Egypt Estonia France Germany Greece Hungary Ireland Israel Italy Japan Kazakhstan Netherlands Norway Poland Portugal Russia Serbia Slovakia Slovenia Spain Sweden Switzerland United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 15135594 (View on PubMed)

Related Links

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Other Identifiers

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ACST-2

Identifier Type: -

Identifier Source: org_study_id