Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients

Not Applicable

Active, not recruiting

• Conditions: Carotid Stenosis

• 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

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-17
• Primary Completion: 2020-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3638

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

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