Carotid Endarterectomy Versus Carotid Artery Stenting in Asymptomatic Patients (ACST-2)

University of Oxford

Status: Active, not recruiting

Conditions: Carotid Stenosis

Treatments: Procedure: CEA, CAS

Study type: Interventional

Funder types: Other

Identifiers

NCT00883402

ACST-2

Details and patient eligibility

About

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

Enrollment: 3,638 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,638 participants in 2 patient groups

CEA

Active Comparator group

Description:

Carotid endarterectomy

Treatment:

Procedure: CEA, CAS

CAS

Active Comparator group

Description:

Carotid Artery Stenting

Treatment:

Procedure: CEA, CAS