Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients
- Conditions
- Carotid Stenosis
- Interventions
- Procedure: CEA, CAS
- Registration Number
- NCT00883402
- Lead Sponsor
- University of Oxford
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3638
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAS CEA, CAS Carotid Artery Stenting CEA CEA, CAS Carotid endarterectomy
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (125)
University of Toledo Medical Centre
🇺🇸Toledo, Ohio, United States
Medical University of Innsbruck
🇦🇹Innsbruck, Austria
University Hospital Antwerp
🇧🇪Antwerp, Belgium
University St Lucas
🇧🇪Brussels, Belgium
Az St Blasius
🇧🇪Dendermonde, Belgium
University Hospital Gent
🇧🇪Gent, Belgium
Centre Hospitalier Régional de la Citadelle
🇧🇪Liege, Belgium
Centre Hospitalier De Mouscron
🇧🇪Mouscron, Belgium
University of Sao Paulo
🇧🇷Sao Paulo, Brazil
HCFM Ribeirao Preto da Universidade de Sao Paulo
🇧🇷São Paulo, Brazil
Sveta Marina Hospital
🇧🇬Varna, Bulgaria
Foothills Medical Centre
🇨🇦Calgary, Canada
China-Japan Friendship Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
University Hospital Centre Zagreb
🇭🇷Zagreb, Croatia
University Hospital of Merkur
🇭🇷Zagreb, Croatia
St Anne's University Hospital Brno
🇨🇿Brno, Czechia
Regional Hospital Liberec
🇨🇿Liberec, Czechia
University Hospital Ostrava Poruba
🇨🇿Ostrava Poruba, Czechia
Central Military Hospital
🇨🇿Prague, Czechia
Hospital Ceské Budejovice
🇨🇿České Budějovice, Czechia
Kasr Alaini University Hospital
🇪🇬Cairo, Egypt
East Tallinn general Hospital
🇪🇪Tallinn, Estonia
Henri Mondor University Hospital
🇫🇷Paris, France
University of Dresden 'Carl-Gustav-Carus'
🇩🇪Dresden, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinik Jena
🇩🇪Jena, Germany
Städtisches Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
University of Leipzig
🇩🇪Leipzig, Germany
Universitätsmedizin Mannheim
🇩🇪Mannheim, Germany
Klinikum rechts der Isar derTechnischen Universität Muenchen
🇩🇪Munich, Germany
St Franziskus-Hospital Münster GmbH
🇩🇪Munster, Germany
Hegau-Bodensee-Klinikum
🇩🇪Singen, Germany
Democritus University of Thrace
🇬🇷Alexandroupolis, Greece
Dept. of Vascular Surgery, Attikon University Hospital
🇬🇷Athens, Greece
University Hospital of Larissa
🇬🇷Larissa, Greece
Semmelweis Medical University
🇭🇺Budapest, Hungary
Albert Szent-Györgyi Medical Centre
🇭🇺Szeged, Hungary
St. James' Hospital
🇮🇪Dublin, Ireland
Rambam Hospital
🇮🇱Haifa, Israel
Cefalu Fondazione Istituto G.Giglio
🇮🇹Cefalu, PA, Italy
Azienda Ospedaliera S.G Moscati
🇮🇹Avellino, Italy
University of Bari
🇮🇹Bari, Italy
University of Bologna
🇮🇹Bologna, Italy
Policlinico Catania
🇮🇹Catania, Italy
Azienda Ospedaliero-Universitaria S.Anna
🇮🇹Ferrera, Italy
San Giovanni Di Dio
🇮🇹Florence, Italy
Opsedale Villa Scassi
🇮🇹Genoa, Italy
IRCCS San Martino
🇮🇹Genoa, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico di Milano
🇮🇹Milan, Italy
IRCCS Policlinico San Donato
🇮🇹Milan, Italy
Istituto Auxologico Italiano
🇮🇹Milan, Italy
San Paolo Hospital
🇮🇹Milan, Italy
Mirano Hospital
🇮🇹Mirano, Italy
Nuovo Ospedale Civile Sant' Agostino Estense
🇮🇹Modena, Italy
Policlinico di Monza
🇮🇹Monza, Italy
Ospedale San Francesco di Nuoro
🇮🇹Nuoro, Italy
University of Palermo
🇮🇹Palermo, Italy
Foundation IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Vascular Endovascular Unit of Perugia
🇮🇹Perugia, Italy
Santa Maria Hospital - Reggio
🇮🇹Raggio, Italy
Policlinico Universitario Campus Bio-medico di Roma
🇮🇹Roma, 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
🇮🇹Rome, Italy
IRCCS Clinico Humanitas
🇮🇹Rozzano, Italy
Santa Maria alle Scotte
🇮🇹Siena, Italy
Ospedali Riuniti di Trieste
🇮🇹Trieste, Italy
Umberto I- ASO Mauriziano
🇮🇹Turin, Italy
Circolo University Hospital
🇮🇹Varese, Italy
San Giacomo Hospital
🇮🇹Veneto, Italy
Sendai Medical Centre
🇯🇵Sendai, Japan
National Scientific Centre of Surgery
🇰🇿Almaty, Kazakhstan
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
MCL Leeuwarden
🇳🇱Leeuwarden, Netherlands
University Hospital Utrecht
🇳🇱Utrecht, Netherlands
Rikshospitalet
🇳🇴Oslo, Norway
Poznan University of Medical Sciences
🇵🇱Poznan, Poland
Bielanski Hospital
🇵🇱Warsaw, Poland
Central Hospital Internal Aff.
🇵🇱Warsaw, Poland
Mazovian Brodnowski Hospital
🇵🇱Warsaw, Poland
University of Warsaw/ Institute of Psychiatry
🇵🇱Warsaw, Poland
Regional Specialist Hospital (Wroclaw)
🇵🇱Wroclaw, Poland
Hospital Santa Marta
🇵🇹Lisbon, Portugal
Novosibirsk Research Institute of Circulation Pathology
🇷🇺Novosibirsk, Russian Federation
Saint Petersburg Scientific Research Institute for Emergency Care
🇷🇺Saint Petersburg, Russian Federation
V.A. Almazov National Medical Research Centre
🇷🇺Saint Petersburg, Russian Federation
Dedinje Cardiovascular Unit
🇷🇸Belgrade, Serbia
Serbian Clinical Centre
🇷🇸Belgrade, Serbia
Institute of Medical Sciences
🇸🇰Ruzomberok, Slovakia
Izola General Hospital
🇸🇮Izola, Slovenia
Teaching Hospital Maribor
🇸🇮Maribor, Slovenia
Hospital Clinic 1 Provinical de Barcelona
🇪🇸Barcelona, Spain
Guadalajara Hospital
🇪🇸Guadalajara, Spain
Hospital Universitari I Politecnic La Fe
🇪🇸Valencia, Spain
Lasarettet Helsingborg
🇸🇪Helsingborg, Sweden
Malmo University Hospital
🇸🇪Malmo, Sweden
Sodersjukhuset
🇸🇪Stockholm, Sweden
Cantonal Hospital Aarau
🇨🇭Aarau, Switzerland
University of Basel
🇨🇭Basel, Switzerland
Southend University Hospital
🇬🇧Westcliff-on-Sea, Essex, United Kingdom
East Kent Hospitals University NHS Foundation Trust
🇬🇧Canterbury, Kent, United Kingdom
Walton Centre
🇬🇧Aintree, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, United Kingdom
Bishop Auckland Hospital
🇬🇧Durham, United Kingdom
University Hospital of North Durham
🇬🇧Durham, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
The Royal London
🇬🇧London, United Kingdom
Luton & Dunstable Hospital
🇬🇧Luton, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
James Cook Hospital
🇬🇧Middlesbrough, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle, United Kingdom
Nottingham University Hospital
🇬🇧Nottingham, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
The Royal Preston Hospital
🇬🇧Preston, United Kingdom
Royal Berkshire
🇬🇧Reading, United Kingdom
Sheffield Vascular Institute
🇬🇧Sheffield, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, United Kingdom
Great Western Hospital
🇬🇧Swindon, United Kingdom
North Cumbria University Hospital
🇬🇧Whitehaven, United Kingdom