Clinical trial NCT00883402: Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients
Official title: Asymptomatic Carotid Surgery Trial-2 (ACST-2): an International Randomised Trial to Compare Carotid Endarterectomy With Carotid Artery Stenting to Prevent Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carotid Stenosis
Keywords: Carotid stenosis
CEA
CAS
Stenting
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: NHS Health Technology Assessment Programme
name: BUPA Foundation
name: British Heart Foundation
First posted: 2009-04-17
Enrollment: 3638
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

The study is looking at immediate risks (within one month)and at long term benefits


Eligibility 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)

Primary outcomes:
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.
timeFrame: 10 years
Secondary outcomes:
measure: 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.
timeFrame: 10 years
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo Medical Centre
state: Ohio
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Brussels
country: Belgium
facility: University St Lucas
city: Dendermonde
country: Belgium
facility: Az St Blasius
city: Gent
country: Belgium
facility: University Hospital Gent
city: Liege
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
city: Mouscron
country: Belgium
facility: Centre Hospitalier De Mouscron
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
city: São Paulo
country: Brazil
facility: HCFM Ribeirao Preto da Universidade de Sao Paulo
city: Varna
country: Bulgaria
facility: Sveta Marina Hospital
city: Calgary
country: Canada
facility: Foothills Medical Centre
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: University Hospital of Merkur
city: Brno
country: Czechia
facility: St Anne's University Hospital Brno
city: Liberec
country: Czechia
facility: Regional Hospital Liberec
city: Ostrava Poruba
country: Czechia
facility: University Hospital Ostrava Poruba
city: Prague
country: Czechia
facility: Central Military Hospital
city: České Budějovice
country: Czechia
facility: Hospital Ceské Budejovice
city: Cairo
country: Egypt
facility: Kasr Alaini University Hospital
city: Tallinn
country: Estonia
facility: East Tallinn general Hospital
city: Paris
country: France
facility: Henri Mondor University Hospital
city: Dresden
country: Germany
facility: University of Dresden 'Carl-Gustav-Carus'
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Jena
country: Germany
facility: Universitätsklinik Jena
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
city: Leipzig
country: Germany
facility: University of Leipzig
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: Munich
country: Germany
facility: Klinikum rechts der Isar derTechnischen Universität Muenchen
city: Munster
country: Germany
facility: St Franziskus-Hospital Münster GmbH
city: Singen
country: Germany
facility: Hegau-Bodensee-Klinikum
city: Alexandroupolis
country: Greece
facility: Democritus University of Thrace
city: Athens
country: Greece
facility: Dept. of Vascular Surgery, Attikon University Hospital
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Budapest
country: Hungary
facility: Semmelweis Medical University
city: Szeged
country: Hungary
facility: Albert Szent-Györgyi Medical Centre
city: Dublin
country: Ireland
facility: St. James' Hospital
city: Haifa
country: Israel
facility: Rambam Hospital
city: Cefalu
country: Italy
facility: Cefalu Fondazione Istituto G.Giglio
state: PA
city: Avellino
country: Italy
facility: Azienda Ospedaliera S.G Moscati
city: Bari
country: Italy
facility: University of Bari
city: Bologna
country: Italy
facility: University of Bologna
city: Catania
country: Italy
facility: Policlinico Catania
city: Ferrera
country: Italy
facility: Azienda Ospedaliero-Universitaria S.Anna
city: Florence
country: Italy
facility: San Giovanni Di Dio
city: Genoa
country: Italy
facility: Opsedale Villa Scassi
city: Genoa
country: Italy
facility: IRCCS San Martino
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
city: Milan
country: Italy
facility: San Paolo Hospital
city: Mirano
country: Italy
facility: Mirano Hospital
city: Modena
country: Italy
facility: Nuovo Ospedale Civile Sant' Agostino Estense
city: Monza
country: Italy
facility: Policlinico di Monza
city: Nuoro
country: Italy
facility: Ospedale San Francesco di Nuoro
city: Palermo
country: Italy
facility: University of Palermo
city: Pavia
country: Italy
facility: Foundation IRCCS Policlinico San Matteo
city: Perugia
country: Italy
facility: Vascular Endovascular Unit of Perugia
city: Raggio
country: Italy
facility: Santa Maria Hospital - Reggio
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-medico di Roma
city: Rome
country: Italy
facility: A.C.O. San Fillippo Neri
city: Rome
country: Italy
facility: Fondazione Policlinico U. Agostino Gemeli IRCCS
city: Rome
country: Italy
facility: San Camillo Forlanini
city: Rome
country: Italy
facility: University La Sapienza
city: Rozzano
country: Italy
facility: IRCCS Clinico Humanitas
city: Siena
country: Italy
facility: Santa Maria alle Scotte
city: Trieste
country: Italy
facility: Ospedali Riuniti di Trieste
city: Turin
country: Italy
facility: Umberto I- ASO Mauriziano
city: Varese
country: Italy
facility: Circolo University Hospital
city: Veneto
country: Italy
facility: San Giacomo Hospital
city: Sendai
country: Japan
facility: Sendai Medical Centre
city: Almaty
country: Kazakhstan
facility: National Scientific Centre of Surgery
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Leeuwarden
country: Netherlands
facility: MCL Leeuwarden
city: Utrecht
country: Netherlands
facility: University Hospital Utrecht
city: Oslo
country: Norway
facility: Rikshospitalet
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
city: Warsaw
country: Poland
facility: Bielanski Hospital
city: Warsaw
country: Poland
facility: Central Hospital Internal Aff.
city: Warsaw
country: Poland
facility: Mazovian Brodnowski Hospital
city: Warsaw
country: Poland
facility: University of Warsaw/ Institute of Psychiatry
city: Wroclaw
country: Poland
facility: Regional Specialist Hospital (Wroclaw)
city: Lisbon
country: Portugal
facility: Hospital Santa Marta
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Circulation Pathology
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg Scientific Research Institute for Emergency Care
city: Saint Petersburg
country: Russian Federation
facility: V.A. Almazov National Medical Research Centre
city: Belgrade
country: Serbia
facility: Dedinje Cardiovascular Unit
city: Belgrade
country: Serbia
facility: Serbian Clinical Centre
city: Ruzomberok
country: Slovakia
facility: Institute of Medical Sciences
city: Izola
country: Slovenia
facility: Izola General Hospital
city: Maribor
country: Slovenia
facility: Teaching Hospital Maribor
city: Barcelona
country: Spain
facility: Hospital Clinic 1 Provinical de Barcelona
city: Guadalajara
country: Spain
facility: Guadalajara Hospital
city: Valencia
country: Spain
facility: Hospital Universitari I Politecnic La Fe
city: Helsingborg
country: Sweden
facility: Lasarettet Helsingborg
city: Malmo
country: Sweden
facility: Malmo University Hospital
city: Stockholm
country: Sweden
facility: Sodersjukhuset
city: Aarau
country: Switzerland
facility: Cantonal Hospital Aarau
city: Basel
country: Switzerland
facility: University of Basel
city: Westcliff-on-Sea
country: United Kingdom
facility: Southend University Hospital
state: Essex
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust
state: Kent
city: Aintree
country: United Kingdom
facility: Walton Centre
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
city: Durham
country: United Kingdom
facility: Bishop Auckland Hospital
city: Durham
country: United Kingdom
facility: University Hospital of North Durham
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: The Royal London
city: Luton
country: United Kingdom
facility: Luton & Dunstable Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Preston
country: United Kingdom
facility: The Royal Preston Hospital
city: Reading
country: United Kingdom
facility: Royal Berkshire
city: Sheffield
country: United Kingdom
facility: Sheffield Vascular Institute
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
city: Swindon
country: United Kingdom
facility: Great Western Hospital
city: Whitehaven
country: United Kingdom
facility: North Cumbria University Hospital
Study officials:
affiliation: University of Oxford
name: Alison Halliday
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.