Purpose:
ACST-2 seeks to compare CEA verses CAS to determine the immediate hazards of the two procedures when done by experienced doctors, and the subsequent stroke rates over the next 5 to 10 years.
Interventions:
Best Medical Treatment
up-to-date medical treatment
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Carotid Artery Stenting
Procedure in which the surgeon inserts a slender, metal-mesh tube, called a stent, which expands inside your carotid artery to increase blood flow in areas blocked by plaque.
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Carotid Endarterectomy
An operation during which the surgeon removes the inner lining of your carotid artery if it has become thickened or damaged. Plaque is removed this way.
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Location(s):
Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Iran, Ireland, Israel, Italy, Lativia, Northern Ireland, Norway, Oman, Pakistan, Paraquay, Poland, Portugal, romania, Russia, Servia, Slovak Republic, Slovernia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Netherlands, turkey, United Kingdom, Ukraine, & United States of America.
Year Started:
2008
Design:
International, multi-center, prospective, randomized trial.
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).
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).
Patient Involvement:
Prior to enrollment, all patients will undergo Duplex sonography and a clinical interview. Eligible patients will be randomized to receive either CEA or CAS. Patient will be seen 30 days after the procedure in clinic. Followed up Yearly (by letter) for 5 years.
Primary Outcome:
To compare 1) peri-procedural risks (myocardial infarction [MI], stroke and death within the first month after the allocated CEA or CAS is attempted by an experienced practitioner), and 2) long-term (up to 5 or more years) prevention of stroke, particularly disabling or fatal stroke, in subsequent years.
Secondary Outcome:
Cost-effectivness of CEA and CAS
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Source of Information:
ACST-2 website
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Web Links and Publications:
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Trials
Directories