Posterior circulation stroke accounts for 20% of all ischemic stroke. Approximately one quarter of posterior circulation strokes are due to stenosis in the vertebral artery and basilar artery. Two previous randomized controlled trials focusing on vertebral artery stenting, the Vertebral Artery Stenting Trial (VAST) and the Vertebral Artery Ischaemia Stenting Trial (VIST) were underpowered because they failed to reach target recruitment, and both the trials found no difference in risk of the primary outcome between the stenting group and medical group. The drug-eluting stenting versus medical therapy alone for patients with extracranial vertebral artery stenosis (VISTA) trial, is a government-funded, prospective, multicenter, randomized controlled trial. It will recruit patients with 3 months stroke or TIA caused by 70-99% stenosis of extracranial vertebral artery (V1-2 segments). Only high-volume center with a proven track record will enroll patients. Patients will be randomized (1:1) to best medical treatment alone or medical treatment plus stenting. Primary outcome is a composite of any fatal or non-fatal stroke within 30 days after randomization, or ischemic stroke in the territory of the target artery beyond 30 days to 1 year. The VISTA trial will be conducted in 30 sites in China and aims to have a sample size of 472 subjects (stenting, 236; medical treatment, 236). Recruitment is expected to be finished by Sep, 2025. Patients will be followed for 1 year at first stage. Long-term follow-ups till 3 years or longer is also preplanned. The first stage of the trial is scheduled to complete in 2027.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
472
All the participants in this group will be performed with extracranial vertebral artery sirolimus-eluting stenting plus medical therapy including aspirin 100mg per day + clopidogrel 75mg per day or ticagrelor 90mg twice per day for 6 months and mono anti-platelet therapy thereafter.
All the participants in this group will be given medical therapy including aspirin 100mg per day + clopidogrel 75mg per day or ticagrelor 90mg twice per day for 6 months and mono anti-platelet therapy thereafter.
mono anti-platelet therapy
Xuanwu Hospital, Capital Medical University.
Beijing, China
RECRUITINGAny fatal or non-fatal stroke within 30 days after randomization, or ischemic stroke in the territory of the target artery beyond 30 days to 1 year.
The number of participants who suffer from any fatal or non-fatal stroke within 30 days after randomization, or ischemic stroke in the territory of the target artery beyond 30 days to 1 year.
Time frame: 1 year
Fatal or non-fatal stroke within 30 days
The number of participants who suffer from fatal or non-fatal stroke within 30 days after randomization.
Time frame: within 30 days
Ischemic stroke in the territory of the target artery beyond 30 days to 1 year
The number of participants who suffer from ischemic stroke in the territory of the target artery beyond 30 days to 1 year.
Time frame: beyond 30 days to 1 year
Ischemic stroke in the territory of the target artery within 1 year
The number of participants who suffer from ischemic stroke in the territory of the target artery within 1 year.
Time frame: within 1 year
Crescendo TIA in the territory of the target artery within 1 year
The number of participants who suffer from crescendo TIA in the territory of the target artery within 1 year.
Time frame: within 1 year
Fatal stroke within 1 year
The number of participants who suffer from fatal stroke within 1 year.
Time frame: within 1 year
Disabling stroke (defined by a modified Rankin Scale Score of ≥3) within 1 year
The number of participants who suffer from disabling stroke (defined by a modified Rankin Scale Score of ≥3) within 1 year.
Time frame: within 1 year
Any stroke within 1 year
The number of participants who suffer from any stroke within 1 year.
Time frame: within 1 year
Any stroke, myocardial infarction or death within 1 year
The number of participants who suffer from any stroke, myocardial infarction or death within 1 year.
Time frame: within 1 year
All cause mortality within 1 year
The number of participants who die of any cause within 1 year.
Time frame: within 1 year
Symptomatic cerebral hemorrhage within 1 year
The number of participants who suffer from symptomatic cerebral hemorrhage within 1 year.
Time frame: within 1 year
Modified Rankin Scale (mRS) score (0-5, higher score refers to a worse outcome)
Modified Rankin Scale (mRS) score at 1 year.
Time frame: at 1 year
In-stent restenosis (Stenosis ≥ 50%)
In-stent restenosis (Stenosis ≥ 50%) at 1 year. Performing CTA or DSA to evaluate the stenosis degree.
Time frame: at 1 year
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