Vertebral artery stenting trial
- Conditions
- Circulatory SystemSymptomatic stenosis of a vertebral artery of at least 50%Cerebral infarction
- Registration Number
- ISRCTN29597900
- Lead Sponsor
- niversity Medical Centre Utrecht (UMCU) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 180
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. Vascular death, non-fatal myocardial infarction, or non-fatal stroke during follow-up*<br>2. Any stroke in the supply territory of the symptomatic vertebral artery during follow-up*<br>3. Degree of stenosis of the symptomatic vertebral artery after one year, as assessed with both Duplex ultrasound and CT angiography<br><br>*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.