Cardiovascular diseases: Cerebrovascular disease Circulatory System Carotid stenosis
Conditions
Interventions
561 patients were entered in three arms of the trial between 1992 and July 1997. Patients with carotid stenosis suitable for surgery (n=504) were randomised between endovascular treatment and carotid
the remainder were treated by balloon angioplasty alone. Patients were followed up by an independent neurologist.
Sponsors
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study patients had to have stenosis of the common carotid artery, carotid bifurcation, internal carotid artery or extracranial vertebral artery that investigators considered suitable for endovascular treatment. Patients eligible for surgery and patients ineligible for surgery were studied and randomised as two separate groups. Investigators included patients only if the best treatment was unclear i.e. patients were randomly assigned only if they and their carotid or vertebral stenosis were equally suitable for both endovascular treatment and the alternative treatment (surgery or best medical care).
Exclusion criteria
Exclusion criteria: Exclusion criteria included patients unable or unwilling to undergo one of the alternative treatment strategies, or who were unable to give informed consent, or if they had a disabling stroke with no useful recovery of function within the region supplied by the treatable artery. Patients were not eligible for the study if angiography showed thrombus in the affected artery, severe intracranial stenosis beyond the skull base, or a stenosis unsuitable for endovascular treatment e.g. because of tortuous vascular anatomy. However, patients did not need to have catheter angiography if a reliable non-invasive investigation had confirmed stenosis. Patients were not excluded if contraindications were noted after random assignment. There was no age limit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival free of disabling stroke | — |
Secondary
| Measure | Time frame |
|---|---|
| Any stroke or death within 30 days of treatment, myocardial infarction within 30 days of treatment, treatment-related cranial nerve palsy or haematoma requiring reoperation or prolonging hospital stay. Stenosis (>70%) and occlusion on ultrasound follow-up. Stroke during follow-up. Further treatment procedure. Quality of life and economic measures. | — |
Countries
United Kingdom
Outcome results
None listed