Ischemic StrokeVISTANCT05885932
Drug-eluting Stenting Versus Medical Treatment for Extracranial Vertebral Artery Stenosis
A study testing Drug-eluting stenting plus aspirin and clopidogrel or ticagrelor, Aspirin and clopidogrel or ticagrelor and mono anti-platelet therapy in people with Ischemic Stroke and Vertebral Artery Stenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Vertebral Artery Stenosis
- What is being tested?
- Drug-eluting stenting plus aspirin and clopidogrel or ticagrelor, Aspirin and clopidogrel or ticagrelor and mono anti-platelet therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2023to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- mRS score ≤ 3.
- Patients or their guardians voluntarily participate of the study and sign the consent form.
Who cannot join
- 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.
- Open surgery or endovascular treatment for other cerebrovascular diseases within 1 month.
- Patients in whom vertebral anatomy was felt to be technically not feasible for vertebral artery stenting (e.g. access problems).
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- 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).
- Known allergy or contraindication to iodinated contrast media and sirolimus.
- History of acute ischemic stroke within 7 days.
- History of intracranial hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or extradural hemorrhage within 6 weeks.
- 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.).
- Coagulation dysfunction or hemorrhagic tendency (e.g. INR > 1.5 and/or platelet count < 100×10^9/L).
- Cannot complete the follow-up due to severe diseases (e.g. serious infections, severe chronic obstructive pulmonary disease, malignancy, dementia, mental illness, uncontrolled server hypertension or diabetes).
- Women who are pregnant or lactating.
- According to the judgement of the investigator, other situations, influencing the safety and efficacy evaluation, which make the patient not suitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University.
Beijing, 100053
Liqun Jiao, Dr., 13911224991, liqunjiao@sina.cn
About this study
Official title: Drug-eluting Stenting Versus Medical Treatment Alone for Patients With Extracranial Vertebral Artery Stenosis: The VISTA 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.
- Conditions
- Ischemic Stroke, Vertebral Artery Stenosis
- Being tested
- Drug-eluting stenting plus aspirin and clopidogrel or ticagrelor, Aspirin and clopidogrel or ticagrelor, mono anti-platelet therapy
- Keywords
- Extracranial vertebral artery stenosis, Drug-eluting stenting, Best medical treatment, Ischemic stroke
- Medical subject headings
- Ischemic Stroke, Vertebrobasilar Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting stenting plus aspirin and clopidogrel or ticagrelorProcedure or surgery
Also called Sirolimus-eluting stenting plus dual antiplatelet therapy
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 ticagrelorDrug
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 therapyProcedure or surgery
mono anti-platelet therapy
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting stenting group | Experimental | 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. Receives: Procedure: Drug-eluting stenting plus aspirin and clopidogrel or ticagrelor |
| Medical group | Active comparator | 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. Receives: Drug: Aspirin and clopidogrel or ticagrelor; Procedure: mono anti-platelet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 1 year
Fatal stroke within 1 year
The number of participants who suffer from fatal stroke within 1 year.
Measured: 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.
Measured: within 1 year
Any stroke within 1 year
The number of participants who suffer from any stroke within 1 year.
Measured: 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.
Measured: within 1 year
All cause mortality within 1 year
The number of participants who die of any cause within 1 year.
Measured: within 1 year
Symptomatic cerebral hemorrhage within 1 year
The number of participants who suffer from symptomatic cerebral hemorrhage within 1 year.
Measured: 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.
Measured: 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.
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start25 Aug 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885932
- Sponsor's protocol ID
- VISTA
- Acronym
- VISTA
- Status last verified
- Sep 2026
- First submitted
- 7 May 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-eluting Stenting Versus Medical Treatment Alone for Patients With Extracranial Vertebral Artery Stenosis: The VISTA Trial
- ClinicalTrials.gov ID
- NCT05885932
- Acronym / sponsor ID
- VISTA / VISTA
- Conditions
- Ischemic Stroke, Vertebral Artery Stenosis
- Keywords
- Extracranial vertebral artery stenosis, Drug-eluting stenting, Best medical treatment, Ischemic stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting stenting group | Experimental | Procedure: Drug-eluting stenting plus aspirin and clopidogrel or ticagrelorAll 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. |
| Medical group | Active comparator | Drug: Aspirin and clopidogrel or ticagrelor, Procedure: mono anti-platelet therapyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
- mRS score ≤ 3.
Key exclusion criteria (15 listed)
- 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.
- Open surgery or endovascular treatment for other cerebrovascular diseases within 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-eluting stenting plus aspirin and clopidogrel or ticagrelorAlso: Sirolimus-eluting stenting plus dual antiplatelet therapyAll 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. | Procedure or surgery | Drug-eluting stenting group |
| Aspirin and clopidogrel or ticagrelorAll 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 | Medical group |
| mono anti-platelet therapymono anti-platelet therapy | Procedure or surgery | Medical group |
Primary outcome
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
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.
12 secondary outcomes
Fatal or non-fatal stroke within 30 days
Time frame: within 30 days
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
Time frame: within 1 year
Crescendo TIA in the territory of the target artery within 1 year
Time frame: within 1 year
Fatal stroke within 1 year
Time frame: within 1 year
Disabling stroke (defined by a modified Rankin Scale Score of ≥3) within 1 year
Time frame: within 1 year
Any stroke within 1 year
Time frame: within 1 year
Any stroke, myocardial infarction or death within 1 year
Time frame: within 1 year
All cause mortality within 1 year
Time frame: within 1 year
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)
Time frame: at 1 year
In-stent restenosis (Stenosis ≥ 50%)
Time frame: at 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-eluting stenting plus aspirin and clopidogrel or ticagrelor, Aspirin and clopidogrel or ticagrelor and mono anti-platelet therapy in people with Ischemic Stroke and Vertebral Artery Stenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.