- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05885932
Drug-eluting Stenting Versus Medical Treatment for Extracranial Vertebral Artery Stenosis (VISTA)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Beijing, China, 100053
- Recruiting
- Xuanwu Hospital, Capital Medical University.
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Contact:
- Liqun Jiao, Dr.
- Phone Number: 13911224991
- Email: liqunjiao@sina.cn
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
|
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.
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
|
1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatal or non-fatal stroke within 30 days
Time Frame: within 30 days
|
The number of participants who suffer from fatal or non-fatal stroke within 30 days after randomization.
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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
|
The number of participants who suffer from ischemic stroke in the territory of the target artery beyond 30 days to 1 year.
|
beyond 30 days to 1 year
|
Ischemic stroke in the territory of the target artery within 1 year
Time Frame: within 1 year
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The number of participants who suffer from ischemic stroke in the territory of the target artery within 1 year.
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within 1 year
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Crescendo TIA in the territory of the target artery within 1 year
Time Frame: within 1 year
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The number of participants who suffer from crescendo TIA in the territory of the target artery within 1 year.
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within 1 year
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Fatal stroke within 1 year
Time Frame: within 1 year
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The number of participants who suffer from fatal stroke within 1 year.
|
within 1 year
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Disabling stroke (defined by a modified Rankin Scale Score of ≥3) within 1 year
Time Frame: within 1 year
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The number of participants who suffer from disabling stroke (defined by a modified Rankin Scale Score of ≥3) within 1 year.
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within 1 year
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Any stroke within 1 year
Time Frame: within 1 year
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The number of participants who suffer from any stroke within 1 year.
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within 1 year
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Any stroke, myocardial infarction or death within 1 year
Time Frame: within 1 year
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The number of participants who suffer from any stroke, myocardial infarction or death within 1 year.
|
within 1 year
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All cause mortality within 1 year
Time Frame: within 1 year
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The number of participants who die of any cause within 1 year.
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within 1 year
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Symptomatic cerebral hemorrhage within 1 year
Time Frame: within 1 year
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The number of participants who suffer from symptomatic cerebral hemorrhage within 1 year.
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within 1 year
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Modified Rankin Scale (mRS) score (0-5, higher score refers to a worse outcome)
Time Frame: at 1 year
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Modified Rankin Scale (mRS) score at 1 year.
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at 1 year
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In-stent restenosis (Stenosis ≥ 50%)
Time Frame: at 1 year
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In-stent restenosis (Stenosis ≥ 50%) at 1 year.
Performing CTA or DSA to evaluate the stenosis degree.
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at 1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pathological Conditions, Anatomical
- Brain Ischemia
- Stroke
- Ischemic Stroke
- Constriction, Pathologic
- Vertebrobasilar Insufficiency
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Aspirin
- Ticagrelor
- Clopidogrel
- Sirolimus
Other Study ID Numbers
- VISTA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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