Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients

Carotid Stenosis Clinical Trial

— ACST-2  

Official title:

Asymptomatic Carotid Surgery Trial-2 (ACST-2): an International Randomised Trial to Compare Carotid Endarterectomy With Carotid Artery Stenting to Prevent Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00883402
• Other study ID #: ACST-2
• Status: Recruiting
• Phase: N/A
• Start date: January 2008
• Est. completion date: December 2020

Study information

• Verified date: April 2019
• Source: University of Oxford
• Contact: Alison Halliday
• Phone: + 44 1865 617975
• Email: acst[@]nds.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3600
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Procedure:
• CEA, CAS
Carotid Artery Stenting (CAS) Carotid endarterectomy (CEA)

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
Belgium	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
Brazil	University of Sao Paulo	Sao Paulo
Brazil	HCFM Ribeirao Preto da Universidade de Sao Paulo	São Paulo
Bulgaria	Sveta Marina Hospital	Varna
Canada	Foothills Medical Centre	Calgary
China	China-Japan Friendship Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
Croatia	University Hospital Centre Zagreb	Zagreb
Croatia	University Hospital of Merkur	Zagreb
Czechia	St Anne's University Hospital Brno	Brno
Czechia	Hospital Ceské Budejovice	Ceské Budejovice
Czechia	Regional Hospital Liberec	Liberec
Czechia	University Hospital Ostrava Poruba	Ostrava Poruba
Czechia	Central Military Hospital	Prague
Egypt	Kasr Alaini University Hospital	Cairo
Estonia	East Tallinn general Hospital	Tallinn
France	Henri Mondor University Hospital	Paris
Germany	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
Greece	Democritus University of Thrace	Alexandroupolis
Greece	Dept. of Vascular Surgery, Attikon University Hospital	Athens
Greece	University Hospital of Larissa	Larissa
Hungary	Semmelweis Medical University	Budapest
Hungary	Albert Szent-Györgyi Medical Centre	Szeged
Ireland	St. James' Hospital	Dublin
Israel	Rambam Hospital	Haifa
Italy	Azienda Ospedaliera S.G Moscati	Avellino
Italy	University of Bari	Bari
Italy	University of Bologna	Bologna
Italy	Policlinico Catania	Catania
Italy	Cefalu Fondazione Istituto G.Giglio	Cefalu	PA
Italy	Azienda Ospedaliero-Universitaria S.Anna	Ferrera
Italy	San Giovanni Di Dio	Florence
Italy	IRCCS San Martino	Genoa
Italy	Opsedale Villa Scassi	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
Japan	Sendai Medical Centre	Sendai
Kazakhstan	National Scientific Centre of Surgery	Almaty
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	MCL Leeuwarden	Leeuwarden
Netherlands	University Hospital Utrecht	Utrecht
Norway	Rikshospitalet	Oslo
Poland	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
Portugal	Hospital Santa Marta	Lisbon
Russian Federation	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
Serbia	Dedinje Cardiovascular Unit	Belgrade
Serbia	Serbian Clinical Centre	Belgrade
Singapore	Khoo Teck Puat Hospital	Singapore
Slovakia	Institute of Medical Sciences	Ruzomberok
Slovenia	Izola General Hospital	Izola
Slovenia	Teaching Hospital Maribor	Maribor
Spain	Hospital Clinic 1 Provinical de Barcelona	Barcelona
Spain	Guadalajara Hospital	Guadalajara
Spain	Hospital Universitari I Politecnic La Fe	Valencia
Sweden	Lasarettet Helsingborg	Helsingborg
Sweden	Malmo University Hospital	Malmo
Sweden	Sodersjukhuset	Stockholm
Switzerland	Cantonal Hospital Aarau	Aarau
Switzerland	University of Basel	Basel
United Kingdom	Walton Centre	Aintree
United Kingdom	East Kent Hospitals University NHS Foundation Trust	Canterbury	Kent
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	Southend University Hospital	Westcliff-on-Sea	Essex
United Kingdom	North Cumbria University Hospital	Whitehaven
United Kingdom	York Hospital	York
United States	University of Toledo Medical Centre	Toledo	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	BUPA Foundation, NHS Health Technology Assessment Programme

Countries where clinical trial is conducted

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,  Russian Federation,  Serbia,  Singapore,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

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. Erratum in: Lancet. 2004 Jul 31;364(9432):416. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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

External Links

•   ACST-2 Website