Stenting of symptomatic vertebral artery stenosis. A randomised safety and feasibility study
- Conditions
- vertebral artery stenosisnarrowing of one of the neck arteries100079631000318410003216
- Registration Number
- NL-OMON38025
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
1. 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 at least two imaging modalities, and presumed to be of atherosclerotic origin and accessible for endovascular treatment
5. score on the modified Rankin scale <= 3 (independent in daily activities, although some help may be needed)
6. age 18 years or older
7. written informed consent
1. potential cause of TIA or minor stroke other than stenosis in a vertebral artery
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
6. severe renal impairment, precluding contrast administration
7. history of severe allergic reaction to iodonised contrast agent
8. pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is any stroke, vascular death, or non-fatal myocardial<br /><br>infarction within 30 days after start of treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures include any stroke or vascular death during<br /><br>follow-up, stroke in the VB territory within 30 days and during follow-up, and<br /><br>the degree of (re)stenosis after one year.</p><br>