carotid artery stenosis
Conditions
Interventions
Study procedures
As the carotid stenosis is asymptomatic, patients will normally have presented
with other vascular problems. ALL patients with uni* or bilateral carotid
stenosis for whom the collab
Sponsors
University of Oxford
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The principal and primary research questions are: Primary objective: 1) What are the differences in clinical myocardial infarction (heart attack) rates and in stroke and death within 30 days of carotid stenting compared with carotid endarterectomy? Secondary objective: 2) What is the difference in the long*term (5*year) survival, free of disabling or fatal stroke for carotid stenting versus carotid endarterectomy? | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are: 3) the rate of restenosis in both treatment groups 4) the cost*effectiveness of carotid stenting compared with surgery? Tertiary outcome measure is: 5) To demonstrate the cerebral white matter state at abseline and evaluate the influence of revascularisation on new cerebral white matter lesions with MRI. | — |
Countries
Netherlands
Outcome results
None listed