Asymptomatic Carotid Surgery Trial -2 (ACST-2). A randomised trial to compare CEA versus CAS to prevent stroke.

Phase 4

Recruiting

Conditions: carotid artery stenosis
carotid plaque
10011954

Registration Number: NL-OMON47429

Lead Sponsor: niversity of Oxford

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

1.Unilateral or bilateral carotid artery stenosis appropriate for surgery or stenting
2.patients'carotid stenosis has not caused symptoms for at least 6 months
3. the patient is fit for, and willing to have carotid surgery or stenting and accessible for follow-up, with no knwon illness preventing long-term follow-up.
4. there is substantial uncertainty about whether the patient is better by surgery or stenting.

Exclusion Criteria

Reasons for not entering patients into the trial are specified by the responsible collaborator, not by the protocol, but include:
1) a small likelihood of worthwhile benefit such as low risk of cerebral infarction from a smooth calcified carotid plaque not causing significant stenosis or some major life threatening disease other than stroke.
2) a high risk of adverse effects of trial treatment such as recent acute myocardial infacrtion or intracerebral neoplasia or aneurysm.
3)those found unsuitable for stenting or surgery after angiography (e.g. because the lesion is surgically inaccessible or because the aortic arch anatomy is difficult for stenting access).
4)re-narrowing of the artery following previous CEA or stent.
5) patients with a likely cardiac source of emboli
6)patients unable or unwilling to give informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The principal and primary research questions are:<br /><br>Primary objective: 1) What are the differences in clinical myocardial<br /><br>infarction (heart attack) rates and in stroke and death within 30 days of<br /><br>carotid stenting compared with carotid endarterectomy?<br /><br>Secondary objective: 2) What is the difference in the longterm (5year)<br /><br>survival, free of disabling or fatal stroke for carotid stenting versus carotid<br /><br>endarterectomy?</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are:<br /><br>3) the rate of restenosis in both treatment groups<br /><br>4) the cost*effectiveness of carotid stenting compared with surgery?<br /><br><br /><br>Tertiary outcome measure is:<br /><br>5) To demonstrate the cerebral white matter state at abseline and evaluate the<br /><br>influence of revascularisation on new cerebral white matter lesions with MRI. </p><br>