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

Official title

Drug-eluting Stenting Versus Medical Treatment Alone for Patients With Extracranial Vertebral Artery Stenosis: The VISTA Trial

Overview

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.

Interventions

• Procedure Drug-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.
• Drug Aspirin 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.
• Procedure mono anti-platelet therapy
  mono anti-platelet therapy

Primary outcome measures

• 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 outcome measures (12)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Xuanwu Hospital, Capital Medical University. — Beijing

Identifiers

NCT: NCT05885932 · VISTA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗