1. Investigate whether in patients with symptomatic vertebral artery stenosis of 50% or greater, stenting of the stenosis is both feasible and safe 2. Obtain informationwhether and how a conclusive clinical trial should be developed in which endovascular treatment plus best medical treatment will be compared to best medical treatment alone in patients with symptomatic vertebral artery stenosis of at least 50% .
- Clopidogrel (Plavix®)Drug
Other Names: Plavix, Clodelib, Clovelen Intervention Desc: Antiplatelet agent
- Best Medical Treatment Procedure
Intervention Desc: up-to-date medical treatment
- Vertebral Artery Stenting Procedure/Surgery
Intervention Desc: The target vertebral artery stenosis is crossed with a guidewire. Either a balloon-mounted stent is advanced over the wire and deployed across the stenosis by inflation of the angioplasty balloon, or an angioplasty balloon is inflated alone, and a self-expanding stent is subsequently placed after removal of the balloon.
Randomised, open, multicentre clinical trial with masked outcome assessment.
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 the discretion of the interventionist. If stent placement is not feasible or deemed contra-indicated, angioplasty without stent placement will be performed. All patients randomised to stenting will receive clopidogrel 75 mg daily starting at least five days before the procedure and continued for 30 days after the procedure. Patients not on clopidogrel the day before the procedure will be loaded with 300 mg clopidogrel at least six hours before stenting. Best medical treatment will be left to the discretion of the neurologist, but should include rigorous control of vascular risk factors, the use of antiplatelet agents, and the use of a statin. *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. 'Best medical treatment' will be continued for the entire duration of the trial (and thereafter).
|Type||Measure||Time Frame||Safety Issue|
|Primary||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||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|