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ISRCTN
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ISRCTN95212240
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ClinicalTrials.gov identifier
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Public title
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Vertebral artery Ischaemia Stenting Trial
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Scientific title
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Acronym
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VIST
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Serial number at source
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N/A
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Study hypothesis
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To compare the risks and benefits of vertebral angioplasty and stenting for symptomatic vertebral stenosis compared with best medical treatment.
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Ethics approval
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Ethics approval received from the Charing Cross Research Ethics Committee on the 24th April 2008 (ref: 08/H0711/2).
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Study design
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A multicentre randomised controlled open prospective clinical trial comparing vertebral stenting with best medical treatment.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stroke/vertebral stenosis
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Participants - inclusion criteria
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1. Women or men aged greater than 20 years of age
2. Symptomatic vertebral stenosis resulting from presumed atheromatous disease
3. Severity of stenosis at least 50% as determined by magnetic resonance angiography (MRA) or computed tomography angiography (CTA) or intra-arterial angiography
4. Symptoms of transient ischaemic attack (TIA) or stroke within the last six months
5. Patient able to provide written informed consent, be willing to be randomised to either treatment, and be willing to participate in follow-up
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Participants - exclusion criteria
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1. Patients unwilling or unable to give informed consent
2. Patients unwilling to accept randomisation to either treatment arm
3. Vertebral stenosis caused by acute dissection as this has a different natural history and usually spontaneously improves
4. Patients in whom vertebral stenting is felt to be technically not feasible e.g. access problems
5. Previous stenting in the randomised artery
6. Pregnant and lactating women
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Anticipated start date
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01/03/2008
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Anticipated end date
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01/03/2016
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Status of trial
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Ongoing |
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Patient information material
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The Patient Information Sheet (PIS) is not available in web format, please contact the department of Clinical Neurosciences, St George's, University of London, on telephone number +44 (0)20 8725 2461 to request a Patient Information Sheet.
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Target number of participants
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Maximum of 1302 (20 in the feasibility phase)
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Interventions
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Patients will be randomised to treatment by stenting or standard drug treatment alone. All patients entering the study will receive the best possible medical treatment including aspirin or similar tablets and treatment of risk factors such as high blood pressure and cholesterol. Patient assessments will be taken at one month after your allocated treatment, and at one year. Patient will also be contacted by telephone at six months and at two, three, four and five years post entry to the study. At one year a further magnetic resonance imaging (MRI) or CT scan to determine the degree of narrowing in the artery.
Stenting will be carried out by an experienced radiologist. He/she will insert a fine wire and tube into an artery in the groin (or occasionally the arm) and this will be used to feed the stent through the blood vessels into the neck. It will be placed across the narrowing in the vertebral artery. This is usually done following a local anaesthetic injection into the groin but you will stay awake during the procedure. Balloons may also be used to dilate the artery before inserting the stent. Sometimes, if the radiologist feels this is a better treatment, the narrowing will be treated by the balloon alone (angioplasty) without insertion of a stent. X-ray pictures (angiography) will be taken immediately before, during, and after stenting to make sure that the wire and stent are in the correct place. In occasional patients the angiography may show that stenting is not possible, or that the degree of narrowing is not as bad as we thought and therefore stenting is not necessary. If this is the case you will be treated with best medical therapy alone.
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Primary outcome measure(s)
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Fatal or disabling stroke in any arterial territory (including periprocedural stroke) defined as a Rankin score of greater than or equal to three, at three months post stroke.
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Secondary outcome measure(s)
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1. Posterior circulation stroke (including periprocedural stroke) during follow-up
2. Posterior circulation stroke and TIA during follow-up
3. Periprocedural stroke and death (within one month of procedure)
4. Periprocedural stroke, death, and TIA (within one month of procedure)
5. Restenosis in treated artery during follow-up
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Sources of funding
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The Stroke Association (UK)
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Trial website
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Publications
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Contact name
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Prof
Hugh
Markus
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Address
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Clinical Neurosciences
St George's University of London
Cranmer Terrace
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City/town
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London
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Zip/Postcode
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SW17 0RE
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Country
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United Kingdom
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Sponsor
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St George's University of London (UK)
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Address
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St George's Research Office
Ground Floor Hunter Wing
Cranmer Terrace
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City/town
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London
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Zip/Postcode
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SW17 0RE
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Country
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United Kingdom
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Sponsor website:
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http://www.sgul.ac.uk/
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Date applied
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15/02/2008
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Last edited
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07/05/2008
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Date ISRCTN assigned
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04/03/2008
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