Clinical trial NCT05885932: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Vertebral Artery Stenosis
Keywords: Extracranial vertebral artery stenosis
Drug-eluting stenting
Best medical treatment
Ischemic stroke
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 transient ischemic attack (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:

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 contraindication 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. INR \> 1.5 and/or platelet count \< 100×10\^9/L).
13. 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).
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.

Primary outcomes:
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.
timeFrame: 1 year
Secondary outcomes:
measure: Fatal or non-fatal stroke within 30 days
timeFrame: within 30 days
measure: Ischemic stroke in the territory of the target artery beyond 30 days to 1 year
timeFrame: beyond 30 days to 1 year
measure: Ischemic stroke in the territory of the target artery within 1 year
timeFrame: within 1 year
measure: Crescendo TIA in the territory of the target artery within 1 year
timeFrame: within 1 year
measure: Fatal stroke within 1 year
timeFrame: within 1 year
measure: Disabling stroke (defined by a modified Rankin Scale Score of ≥3) within 1 year
timeFrame: within 1 year
measure: Any stroke within 1 year
timeFrame: within 1 year
measure: Any stroke, myocardial infarction or death within 1 year
timeFrame: within 1 year
measure: All cause mortality within 1 year
timeFrame: within 1 year
measure: Symptomatic cerebral hemorrhage within 1 year
timeFrame: within 1 year
measure: Modified Rankin Scale (mRS) score (0-5, higher score refers to a worse outcome)
timeFrame: at 1 year
measure: In-stent restenosis (Stenosis ≥ 50%)
timeFrame: at 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University.
Study officials:
References: