Symptomatic stenosis of a vertebral artery of at least 50% Circulatory System Cerebral infarction
Conditions
Interventions
The trial will compare the combination of vertebral artery stenting and best medical treatment with best medical treatment alone. The type of stent and the use of a protection device will be left to t
Sponsors
University Medical Centre Utrecht (UMCU) (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Transient ischaemic attack (TIA) or non-disabling ischaemic stroke of the posterior circulation 2. Symptoms must have occurred in the 180 days preceding randomisation 3. Possibility to perform stenting within two weeks after randomisation 4. Stenosis of the vertebral artery of 50% or greater, diagnosed by both duplex ultrasound and computed tomography (CT-), contrast-enhanced magnetic resonance (MR-), or conventional angiography, and presumed to be of atherosclerotic origin and accessible for endovascular treatment 5. Score on the modified Rankin scale less than or equal to 3 (independent in daily activities, although some help may be needed) 6. Aged 40 years or older, either sex 7. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Potential cause of TIA or minor stroke other than stenosis in a vertebral artery (e.g. atrial fibrillation) 2. Vertebral artery stenosis caused by arterial dissection 3. Previous surgical or endovascular treatment of the stenosis 4. Life expectancy shorter than three years 5. Other serious illness that may confound outcome assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascular death, non-fatal myocardial infarction, or non-fatal stroke (neurological deficit lasting longer than 24 hours for which no other cause than a stroke can be found) within 30 days after start of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Vascular death, non-fatal myocardial infarction, or non-fatal stroke during follow-up* 2. Any stroke in the supply territory of the symptomatic vertebral artery during follow-up* 3. Degree of stenosis of the symptomatic vertebral artery after one year, as assessed with both Duplex ultrasound and CT angiography *Follow-up visits will be performed at one day and at 1, 6, and 12 months after stenting (or randomisation in the conservative treatment group) and every year thereafter. The close-out visit of each patient will be scheduled one year after randomisation of the last patient, expected in December 2011. | — |
Countries
Netherlands
Outcome results
None listed