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Summary Protocol
The full protocol can be downloaded (170kb) in pdf format by right clicking here and selecting 'save target as' Background: Clinical trials have shown that carotid surgery prevents stroke but also has significant morbidity. Stenting has become an established alternative treatment for coronary and peripheral vascular disease and has the advantage of avoiding general anaesthesia and neck incision. In July 1997, randomisation was completed in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS). The results did not show a difference in the major risks or benefits of carotid angioplasty and surgery, but the trial did show that both methods still carry a significant risk of causing a stroke. Techniques of carotid angioplasty have improved and stenting is increasingly used. The International Carotid Stenting Study (ICSS or CAVATAS 2) is a follow-on study to CAVATAS designed as an international, multicentre, randomised trial, which will evaluate stenting of carotid artery stenosis in patients with cerebrovascular disease. Centre requirements: A neurologist or physician with an interest in stoke; a surgeon with expertise in carotid endarterectomy and an interventionalist with expertise in carotid angiography and the techniques of angioplasty and stenting. Inclusion criteria: Symptomatic atheromatous carotid stenosis, > 50% by NASCET criteria, suitable for stenting and surgical endarterectomy. Treatments: Patients will be randomised in equal proportions to be treated by carotid endarterectomy or stenting. New design of stents, filters and protection devices will be incorporated into the study to allow tracking of new technology if approved by the Steering Committee. Surgery can be performed with local or general anaesthesia . Sample size: N = 1500 patients from fully enrolled centres. Sample size calculations show that the 95% confidence intervals will be ± 3.0 percentage points for the outcome measure of 30 day stroke, myocardial infarction and death rate and ± 3.3 percentage points for the outcome measure of death or disabling stroke during follow-up. Primary outcome measure: Long term survival free of disabling stroke. Secondary outcome measures: Any stroke, myocardial infarction or death within 30 days of treatment, treatment-related cranial nerve palsy or haematoma. Stenosis (>70%) and occlusion on ultrasound follow-up. Transient ischaemic attack. Stroke during follow-up. Further treatment procedure. Quality of life and economic measures.
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