Actively Recruiting
Drug-eluting Stenting Versus Medical Treatment for Extracranial Vertebral Artery Stenosis
Led by Xuanwu Hospital, Beijing · Updated on 2023-09-21
472
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Drug-eluting Stenting Versus Medical Treatment for Extracranial Vertebral Artery Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- 70% to 99% narrowing of extracranial vertebral artery (V1-2 segments) with target vessel diameter 2.5mm or larger
- History of ischemic stroke (mRS score 3 or less) or transient ischemic attack within 3 months before randomization
- Presence of at least two atherosclerotic risk factors such as hypertension, hyperlipidemia, diabetes, smoking, drinking, obesity, or obstructive sleep apnea
- Modified Rankin Scale score of 3 or less
- Voluntary participation with signed informed consent
You will not qualify if you...
- Vertebral artery narrowing caused by non-atherosclerotic diseases such as arterial dissection, Moyamoya disease, vasculitis, radiation-induced vascular disease, or fibromuscular dysplasia
- Severe narrowing or blockage in other extracranial or intracranial parts of the target vessel
- Previous open surgery or endovascular treatment on the target vessel
- Other cerebrovascular diseases requiring surgery or endovascular therapy
- Surgery or endovascular treatment for other cerebrovascular diseases within 1 month
- Vertebral artery anatomy unsuitable for stenting
- Lesions in the opposite vertebral artery or basilar artery that may cause symptoms making it unclear which vessel is responsible
- Allergy or contraindication to iodinated contrast media or sirolimus
- Acute ischemic stroke within 7 days
- Intracranial hemorrhage or related bleeding within 6 weeks
- Cardioembolic strokes or multiple territory strokes linked to heart conditions
- Blood clotting problems or bleeding tendencies
- Severe illnesses preventing follow-up such as serious infections, COPD, cancer, dementia, mental illness, uncontrolled severe hypertension or diabetes
- Pregnant or breastfeeding women
- Other conditions judged by investigators to affect safety or evaluation suitability
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University.
Beijing, China, 100053
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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