Drug-eluting Stenting Versus Medical Treatment for Extracranial Vertebral Artery Stenosis
Status:
Not yet recruiting
Trial end date:
2028-09-01
Target enrollment:
Participant gender:
Summary
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.