Carotid stenosis/stroke Circulatory System Cerebral infarction
Conditions
Interventions
Patients will be randomised in equal proportions to be treated by carotid endarterectomy or stenting.
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Symptomatic, extracranial, internal or bifurcation, atheromatous carotid artery stenosis that is suitable for both stenting and surgery and is deemed by the randomising clinician to require treatment 2. The severity of the stenosis of the randomised artery should be at least 50% (as measured by the North American Symptomatic Carotid Endarterectomy Trial [NASCET] method or non-invasive equivalent) 3. Symptoms must have occurred in the 12 months before randomisation. It is recommended that the time between symptoms and randomisation should be less than 6 months, but patients with symptoms occurring between 6 and 12 months may be included if the randomising physician considers treatment indicated 4. The patient must be clinically stable following their most recent symptoms attributable to the stenotic vessel 5. Patients must be willing to have either treatment, be able to provide informed consent, and be willing to participate in follow up 6. Patients must be able to undergo their allocated treatment as soon as possible after randomisation 7. Any age greater than 40 may be included. There is no upper age limit. 8. Patients should only be randomised if the investigator is uncertain which of the two treatments is best for that patient at that time
Exclusion criteria
Exclusion criteria: 1. Patients refusing either treatment 2. Patients unable or unwilling to give informed consent 3. Patients unwilling or unable to participate in follow up for whatever reason 4. Patients who have had a major stroke with no useful recovery of function within the territory of the treatable artery 5. Patients with a stenosis that is known to be unsuitable for stenting prior to randomisation because of one or more of: 5.1. Tortuous anatomy proximal or distal to the stenosis 5.2. Presence of visible thrombus 5.3. Proximal common carotid artery stenotic disease 5.4. Pseudoocclusion ('string sign') 6. Patients not suitable for surgery due to anatomical factors e.g. high stenosis, rigid neck 7. Patients in whom it is planned to carry out coronary artery bypass grafting or other major surgery within 1 month of carotid stenting or endarterectomy 8. Carotid stenosis caused by non-atherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy 9. Previous carotid endarterectomy or stenting in the randomised artery 10. Patients in who common carotid artery surgery is planned 11. Patients medically not fit for surgery 12. Patients who have a life expectancy of less than two years due to a pre-existing condition, e.g. cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added as of 07/02/2007: 1. Any stroke or death 2. MI Within 30 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 07/02/2007: 1. Cranial nerve palsy within 30 days of treatment 2. Haematoma caused by treatment requiring surgery 3. Transfusion or prolonging hospital stay 4. Stenosis greater than 70% or occlusion during follow up 5. Further treatment of the randomised artery by interventional radiology techniques or surgery after the initial attempt 6. Quality of life 7. Health status 8. Health Service costs | — |
Countries
England, United Kingdom
Outcome results
None listed