|
ISRCTN
|
ISRCTN29597900
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Vertebral Artery Stenting Trial
|
|
Scientific title
|
Stenting of symptomatic vertebral artery stenosis: a randomised safety and feasibility study
|
|
Acronym
|
VAST
|
|
Serial number at source
|
1.0
|
|
Study hypothesis
|
1. In patients with symptomatic vertebral artery stenosis of 50% or greater, stenting of the stenosis is both feasible and safe
2. In the present trial, sufficient information will be obtained about whether 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%
|
|
Ethics approval
|
Ethics approval received from the Ethics Review Board of the University Medical Centre in Utrecht (The Netherlands) on the 22nd January 2008 (ref: 07-245/E).
|
|
Study design
|
Randomised, open, multicentre clinical trial with masked outcome assessment
|
|
Countries of recruitment
|
The Netherlands
|
|
Disease/condition/study domain
|
Symptomatic stenosis of a vertebral artery of at least 50%
|
|
Participants - inclusion criteria
|
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
|
|
Participants - exclusion criteria
|
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
|
|
Anticipated start date
|
01/04/2008
|
|
Anticipated end date
|
31/12/2012
|
|
Status of trial
|
Ongoing |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet. Patient information is available in Dutch.
|
|
Target number of participants
|
180
|
|
Interventions
|
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 will continue until one year after inclusion of the last patient, which is expected in December 2011. 'Best medical treatment' will be continued for the entire duration of the trial (and thereafter).
|
|
Primary outcome measure(s)
|
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 measure(s)
|
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
*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.
|
|
Sources of funding
|
Netherlands Heart Foundation (Nederlandse Hartstichting) (NHS) (The Netherlands) (ref: 2007B045)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
H. Bart
van der Worp
|
|
Address
|
Department of Neurology, HP G 03.228
UMC Utrecht
Heidelberglaan 100
|
|
City/town
|
Utrecht
|
|
Zip/Postcode
|
3584 CX
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)88 755 5555, tracer 1833
|
|
Fax
|
+31 (0)30 254 2100
|
|
Email
|
h.b.vanderworp@umcutrecht.nl
|
|
Sponsor
|
University Medical Centre Utrecht (UMCU) (The Netherlands)
|
|
Address
|
Heidelberglaan 100
|
|
City/town
|
Utrecht
|
|
Zip/Postcode
|
3584 CX
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)88 755 5555
|
|
Fax
|
+31 (0)30 254 2100
|
|
Email
|
info@umcutrecht.nl
|
|
Sponsor website:
|
http://www.umcutrecht.nl
|
|
Date applied
|
14/02/2008
|
|
Last edited
|
20/03/2008
|
|
Date ISRCTN assigned
|
20/03/2008
|
