Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients

Status unconfirmed · Not applicable

Conditions studied: Carotid Stenosis

In brief

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

Key facts

Study ID

NCT00883402

Run by

University of Oxford

People needed

3638

Starts

2008-01-01

Expected to finish

2025-12-01

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Medical University of Innsbruck — Innsbruck, Austria
• University Hospital Antwerp — Antwerp, Belgium
• University St Lucas — Brussels, Belgium
• Az St Blasius — Dendermonde, Belgium
• University Hospital Gent — Ghent, Belgium
• Centre Hospitalier Régional de la Citadelle — Liège, Belgium
• Centre Hospitalier De Mouscron — Mouscron, Belgium
• HCFM Ribeirao Preto da Universidade de Sao Paulo — São Paulo, Brazil
• University of 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
• Hospital Ceské Budejovice — České Budějovice, Czechia
• Regional Hospital Liberec — Liberec, Czechia
• University Hospital Ostrava Poruba — Ostrava Poruba, Czechia
• Central Military Hospital — Prague, 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
• University of Toledo Medical Centre — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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