Stroke Circulatory System Cerebrovascular diseases
Conditions
Interventions
Immediate endartorectomy and optimised medical therapy.
All patients will have their medication adjusted to reach recommended levels for cholesterol and blood pressure, and receive advice about healt
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years of age with atherosclerotic carotid stenosis equivalent to at least 50% measured using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method 2. Patient is medically and neurologically stable and suitable for CEA or carotid artery stenting (CAS) 3. Patients with a carotid artery risk (CAR) score indicating a 5-year ipsilateral stroke risk of <20%. This may include patients with asymptomatic stenosis or symptomatic stenosis associated with features (e.g. delayed presentation) indicating intermediate or lower risk, confirmed by CAR Score <20% 4. Clinicians are uncertain about which treatment modality is best for the individual patient 5. Patient or appropriate representative is able and willing to give informed consent 6. Male and female participants
Exclusion criteria
Exclusion criteria: 1. Patients (or their representatives) unwilling to have either treatment modality 2. Patients unwilling or unable to participate in follow up for whatever reason 3. Patients with a Rankin score greater than 3 for any reason. Such patients may be eligible for inclusion at such time as they improve to a Rankin score of 3 or less 4. Patients who are medically or neurologically unstable or have progressing neurological signs. Such patients may be eligible for inclusion at such time as they become stable 5. Patients in whom it is planned to carry out coronary artery bypass grafting or other major surgery within one month of carotid stenting or endarterectomy 6. Patients with a CAR Score >20% or other reason for believing the patient would get clear benefit from CEA or CAS 7. Patients not suitable for either surgery or stenting due to anatomical factors 8. Carotid stenosis caused by nonatherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy 9. Previous CEA or stenting in the randomised artery 10. Patients who are known to be pregnant 11. Patients who have a life expectancy of less than two years due to a preexisting condition e.g. cancer 12. Patients intolerant or allergic to all of the medications available for optimised modern medical therapy 13. Patients in clinical trials of medicinal products (CTIMPS) or who have been in a CTIMP within the last 4 months will not be enrolled 14. Patients in other trials (both stroke related and non stroke related) may be enrolled where this would not conflict with the treatments used in ECST2 or place undue additional burdens on the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any stroke at any time + non-stroke death within 30 days of endartorectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 06/05/2016: The long-term rates of the following outcomes: 1. Ipsilateral stroke, confirmed/probable TIA, MI or any hospitalisation for vascular disease during follow up 2. Disabling stroke during follow up 3. New cerebral infarction or parenchymal haemorrhage on follow up MRI 4. Increase in white-matter changes on follow up MRI 5. Revascularisation during follow-up 6. Stenosis progression (defined as recurrent stenosis of the randomised artery after revascularisation, or progression in severity of stenosis in a non-revascularised artery) 7. The combination of stenosis progression or revascularisation during follow-up 8. Functional status as assessed by comparison of modified Rankin scale scores 9. The cost-effectiveness of carotid endarterectomy with OMT compared to OMT alone 10. Cognitive impairment or dementia during follow up reported by the investigator and measured by the Montreal Cognitive Assessment (MoCA) 11. Decline in functional status as assessed by an increase in the modified Rankin score (mRS) 12. Health-related quality of life and economic costs Secondary analysis will also examine the risk factors for stroke, cognitive impairment and the other main outcome events during long term follow up (including the risks related to age, sex, symptoms, baseline brain imaging, centre and technique). In centres performing the relevant additional investigations, secondary analyses will examine the relationship between the main outcome events and baseline measures of plaque instability as determined by MR plaque imaging. | — |
Countries
Canada, England, France, Germany, Italy, Netherlands, Scotland, Switzerland, United Kingdom
Outcome results
None listed