carotid narrowing
Conditions
Interventions
carotid revascularisation (endarterectomy or, in exceptional cases, stenting) +
medication vs medication alone
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - > 18 years of age - symptomatic or asymptomatic atherosclerotic carotid stenosis equivalent to at least 50% measured using de NASCET method - CAR (carotid artery risk) score
Exclusion criteria
Exclusion criteria: - Modified Rankin score > 2 - previous endarterectomy or stent in the randomised artery - coronary artery bypass grafting within 3 months prior to randomisation or other major surgery within 6 weeks prior to randomisation - coronary artery bypass grafting or other major surgery planned within 6 weeks randomisation - pregnancy - life expectancy of less than two years due to a pre-existing condition e.g. cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any stroke at any time, plus non-stroke death occurring within 30 days of revascularisation | — |
Secondary
| Measure | Time frame |
|---|---|
| - Ipsilateral stroke - myocardial infarction or any hospitalisation for - vascular disease during follow up. - Disabling stroke during follow up. - New cerebral infarction or haemorrhage on post procedural MRI. - Cognitive impairment. - Further treatment procedure. - Adverse events attributed to medical treatment or CEA. - Quality of life and economic measures. | — |
Countries
Netherlands
Outcome results
None listed