Condition category
Circulatory System
Date applied
15/02/2008
Date assigned
04/03/2008
Last edited
06/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Narrowing (stenosis) of the vertebral and basilar arteries in the neck, which supply blood to the back of the brain, is an important cause of stroke. Patients with stroke due to vertebral and basilar artery stenosis have an increased risk of further stroke. We can now treat vertebral stenosis with a stent. This involves placing a small tube made of wire mesh inside the narrowed artery in the neck. The stent is passed into the artery through a small tube (catheter) inserted into the groin under local anaesthetic. Once in position across the narrowing the stent is opened out where it acts like a spring to keep the artery open. Stenting has been successfully used in the arteries supplying the heart and the legs and it is now a routine treatment for these diseases. It has also been used in many cases of narrowing of the arteries at the front of the brain (carotid arteries). Hundreds of cases of vertebral stenosis have been treated by stents worldwide but we don't yet have any information as to whether it is better to perform stenting or to treat with drugs alone. Therefore in this study, which will be carried out in many different hospitals, we are comparing whether stenting is better than standard drug treatment alone in patients who have had recent stroke due to vertebral stenosis.

Who can participate?
Women or men over 20 years of age who have had a recent stroke and also have vertebral stenosis.

What does the study involve?
To find out which treatment is better, half of the patients entering the study will be allocated to treatment by stenting and the other half will be treated with standard drug treatment alone. Which treatment you are allocated to will be decided by a computer. This random allocation is important if we are to determine fairly which of the two treatments is better. 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. If you agree to take part your GP will be informed and you will be seen by a neurologist or stroke doctor about 1 month after your allocated treatment, and at 1 year. We will also contact you by telephone at 6 months and yearly from year 2 onward until the end of the study. At 1 year we will perform a further MRI or CT scan to determine the degree of narrowing in the artery. You will be asked to fill in a diary recording contact with Health Services. Any travel expenses incurred from the visits of this study will be reimbursed.
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.

What are the possible benefits and risks of participating?
All patients taking part in the study will receive careful follow-up and the opportunity to benefit from advances in treatment. Stenting carries a risk of causing a stroke at the time of treatment. Previous studies have suggested this is about five per every hundred patients. There is also a risk of about one in every hundred that angiography will cause stroke. On the other hand, if we do not treat the stenosis there is a risk of having a further stroke. We are not sure whether the risk of stenting is greater than the risk if we do not perform the stenting, and that is why we are carrying out the study. Angiography and stenting may also result in bruising at the site of the introduction of the stent (usually the groin). There can be temporary pain or discomfort in the neck when the balloon is blown up. If you receive stenting then X-rays are required to allow us to ensure that the stent is placed in the correct position and this does involve a small radiation dose which may carry a small risk of induced cancer (1 in 1300).

Where is the study run from?
This study is being co-ordinated from St George's, University of London and the University of Cambridge (UK).

When is the study starting and how long is it expected to run for?
The study started in March 2008 and will run until November 2017.

Who is funding the study?
The Stroke Association and the NIHR Health Technology Assessment Programme.

Who is the main contact?
Prof Hugh Markus

Trial website

http://www.vist.org.uk/

Contact information

Type

Scientific

Primary contact

Prof Hugh Markus

ORCID ID

Contact details

Department of Clinical Neurosciences
R3
Box 83
Cambridge Biomedical Campus
Cambridge
CB2 0QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Vertebral artery Ischaemia Stenting Trial

Acronym

VIST

Study hypothesis

To compare the risks and benefits of vertebral angioplasty and stenting for symptomatic vertebral stenosis compared with best medical treatment.

Protocol can be found at: http://www.vist.sgul.ac.uk/vist-protocol-version-7.0-04dec2013.pdf

On 06/02/2013 the following changes were made to the record:
1. The target number of participants was updated from 1302 to 540
2. The overall trial end date was updated from 01/03/2016 to 01/11/2017

Ethics approval

Charing Cross Research Ethics Committee, 24/04/2008, ref: 08/H0711/2

Study design

Multicentre randomised controlled open prospective clinical trial comparing vertebral stenting with best medical treatment.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.vist.sgul.ac.uk/vist-patient-information-sheet-version-8-04-dec-2013-clean.doc

Condition

Stroke/vertebral stenosis

Intervention

Current interventions as of 06/02/2013:
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 follow-up via telephone will range from 2 years for the last recruited patients to up to about 8 years for first patients recruited. 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.

Previous interventions until 06/02/2013:
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.

The previous sponsor for this trial (up to 24/04/2014) was:
St George's University of London (UK)
St George's Research Office
Ground Floor Hunter Wing
Cranmer Terrace
London
SW17 0RE
United Kingdom

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Current primary outcome measures as of 06/02/2013:
Fatal or non-fatal stroke in any arterial territory (including periprocedural stroke) during trial follow up

Previous primary outcome measures until 06/02/2013:
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.

Secondary outcome measures

Current secondary outcome measures as of 06/02/2013:
1. Fatal or non-fatal stroke in any arterial territory (including periprocedural stroke) at three months post-randomisation
2. Posterior circulation stroke (including periprocedural stroke) during follow-up
3. Periprocedural stroke or death (within 30 days of procedure)
4. Posterior circulation stroke and TIA during follow-up
5. Any disabling stroke (defined by a Rankin >=3) during follow-up
6. Death of any cause during follow-up
7. Restenosis in treated artery during follow-up
8. NHS and personal social services costs
9. Quality-adjusted life years
10. Within-trial and long-run incremental cost-effectiveness

Previous secondary outcome measures until 06/02/2013:
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

Overall trial start date

01/03/2008

Overall trial end date

01/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 06/02/2013:
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 three 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
6. If randomised to stenting, this can be performed within two weeks after randomization.

Previous inclusion criteria until 06/02/2013:
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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

540 (100 in the feasibility phase as of 19/04/2011)

Participant exclusion criteria

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

Recruitment start date

01/03/2008

Recruitment end date

01/11/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cambridge Biomedical Campus
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust & University of Cambridge (UK)

Sponsor details

c/o Stephen Kelleher
R&D Manager
Cambridge University Hospitals
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

University/education

Website

http://www.cuh.org.uk/

Funders

Funder type

Charity

Funder name

Stroke Association

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Funder name

NIHR HTA Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes