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Drug-eluting Stenting Versus Medical Treatment for Extracranial Vertebral Artery Stenosis

ConditionsIschemic StrokeVertebral Artery Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Extracranial vertebral artery (V1-2 segments) has 70% to 99% stenosis (NASCET criteria by angiography), and the diameter of the target vessel ≥ 2.5mm.

History of clinical symptoms associated with target vessels within 3 months before randomization, including ischemic stroke (modified Rankin Scale, mRS score ≤ 3) or transient ischemic attack (TIA).

With more than two atherosclerotic risk factors such as, hypertension, hyperlipidemia, diabetes, smoking, drinking, obesity, or obstructive sleep apnea (following the 2021 AHA/ASA guidelines).

Disqualifiers

Vertebral artery stenosis caused by non-atherosclerotic lesions, including arterial dissection, Moyamoya disease, vasculitis disease, radiation-induced vascular disease, fibromuscular dysplasia, etc.

Tandem extracranial or intracranial severe stenosis or occlusion of the target vessel.

History of open surgery or endovascular treatment of the target vessel.

Other cerebrovascular diseases that require one-stage open surgery or endovascular therapies.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drug-eluting stenting plus aspirin and clopidogrel or ticagrelor

    Procedure/Surgery

    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.

  • Aspirin and clopidogrel or ticagrelor

    Drug

    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

    Procedure/Surgery

    mono anti-platelet therapy

Treatment groups

472 Participants
are divided into 2 treatment groups
Group A: Drug-eluting stenting groupExperimental treatment 1 intervention
Group B: Medical groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanwu Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov
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