ClinicalTrials.gg
RecruitingNCT05885932VISTAUpdated Sep 10, 2026

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

An interventional study of Drug-eluting stenting plus aspirin and clopidogrel or ticagrelor and Aspirin and clopidogrel or ticagrelor in Ischemic Stroke and Vertebral Artery Stenosis, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
472
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 52 studies in Ischemic Stroke by Xuanwu Hospital, Beijing — 30 open to participants now, 31 under way, 2 of them phase 3. Ischemic Stroke · Xuanwu Hospital, Beijing.

Planned enrollment
11th of 28
472 · median 325
Started
2023
with 8 others
No phase
14 of 52
10 open now
Primary completion
2027-11
later than 20 of 30 live
Registered
21st of 52
by date

Among the 52 studies in Ischemic Stroke by Xuanwu Hospital, Beijing, this one is the 11th largest by planned enrollment of the 28 interventional ones that give a count, is one of 9 that started in 2023, is one of 14 with no phase, reaches primary completion later than 20 of the 30 other live ones, and was the 21st registered.

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

30 of the 52 studies in Ischemic Stroke by Xuanwu Hospital, Beijing are open now, in 1 country. Recruiting first, the newest first:

24 more — sign in →

By country, each count listing its studies:

All 30 open studies →

Where they have run

Who these studies take

Of the 655 Ischemic Stroke studies recruiting now, 394 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 41 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 52 studies in Ischemic Stroke by Xuanwu Hospital, Beijing, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Ischemic Stroke
  • Vertebral Artery Stenosis

Keywords

  • Extracranial vertebral artery stenosis
  • Drug-eluting stenting
  • Best medical treatment
  • Ischemic stroke
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years.
  2. Extracranial vertebral artery (V1-2 segments) has 70% to 99% stenosis (NASCET criteria by angiography), and the diameter of the target vessel ≥ 2.5mm.
  3. History of clinical symptoms associated with target vessels within 3 months before randomization, including ischemic stroke (modified Rankin Scale, mRS score ≤ 3) or (TIA).
  4. 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).
  5. mRS score ≤ 3.
  6. Patients or their guardians voluntarily participate of the study and sign the consent form.

Exclusion criteria

Exclusion Criteria:

  1. Vertebral artery stenosis caused by non-atherosclerotic lesions, including arterial dissection, Moyamoya disease, vasculitis disease, radiation-induced vascular disease, fibromuscular dysplasia, etc.
  2. Tandem extracranial or intracranial severe stenosis or occlusion of the target vessel.
  3. History of open surgery or endovascular treatment of the target vessel.
  4. Other cerebrovascular diseases that require one-stage open surgery or endovascular therapies.
  5. Open surgery or endovascular treatment for other cerebrovascular diseases within 1 month.
  6. Patients in whom vertebral anatomy was felt to be technically not feasible for vertebral artery stenting (e.g. access problems).
  7. The contralateral vertebral artery and basilar artery have lesions that may be related to the symptoms, and the investigators cannot confirm that the target vessel is the responsible vessel for the symptoms (For example, the ostium of bilateral vertebral artery is severely narrowing, and the diameter of vertebral artery is equal, unable to determine the dominant vertebral artery).
  8. Known allergy or to iodinated contrast media and sirolimus.
  9. History of acute ischemic stroke within 7 days.
  10. History of intracranial hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or extradural hemorrhage within 6 weeks.
  11. Cardioembolic strokes as evident by prior history of strokes in other territories or multi-territory strokes in the presence of risk factors known to be associated with cardiogenic embolism (e.g. atrial fibrillation, left ventricular thrombus or history of myocardial infarction within 6 weeks, etc.).
  12. Coagulation dysfunction or hemorrhagic tendency (e.g. > 1.5 and/or count \< 100×10\^9/L).
  13. Cannot complete the follow-up due to severe diseases (e.g. serious infections, severe , , dementia, mental illness, uncontrolled server hypertension or diabetes).
  14. Women who are pregnant or lactating.
  15. According to the judgement of the investigator, other situations, influencing the safety and efficacy evaluation, which make the patient not suitable for enrollment.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
472 participants (estimated)

Study arms

  • Experimental
    Drug-eluting stenting group

    All the participants in this group will be performed with extracranial vertebral artery sirolimus-eluting stenting plus best medical treatment including Aspirin 100mg per day + Clopidogrel 75mg per day or Ticagrelor 90mg twice per day for 6 months and mono anti-platelet therapy thereafter.

    Procedure: Drug-eluting stenting plus aspirin and clopidogrel or ticagrelor

  • Active comparator
    Medical group

    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.

    Drug: Aspirin and clopidogrel or ticagrelor · Procedure: mono anti-platelet therapy

Interventions

  • ProcedureDrug-eluting stenting plus aspirin and clopidogrel or ticagrelor

    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.

    Also known as: Sirolimus-eluting stenting plus dual antiplatelet therapy

  • DrugAspirin and clopidogrel or ticagrelor

    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.

  • Proceduremono anti-platelet therapy

    mono anti-platelet therapy

06

What researchers measure

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

  5. Fatal stroke within 1 year

    The number of participants who suffer from fatal stroke within 1 year.

    Time frame: within 1 year

  6. 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

  7. Any stroke within 1 year

    The number of participants who suffer from any stroke within 1 year.

    Time frame: within 1 year

  8. 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

  9. All cause mortality within 1 year

    The number of participants who die of any cause within 1 year.

    Time frame: within 1 year

  10. Symptomatic cerebral hemorrhage within 1 year

    The number of participants who suffer from symptomatic cerebral hemorrhage within 1 year.

    Time frame: within 1 year

  11. 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

  12. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2023 (actual). Primary completion is estimated for Nov 2027, 51 months after the start.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 51 months is above that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2023
First posted
Jun 2, 2023
StartActual
Aug 25, 2023
Primary completionEst.
Nov 30, 2027
CompletionEst.
Sep 1, 2028
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05885932
Responsible party
Sponsor
First posted
Jun 2, 2023
Start date
Aug 25, 2023
Primary completion
Nov 30, 2027 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Sep 10, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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