Actively Recruiting
Drug-eluting Stenting Versus Medical Treatment Alone for Patients With Extracranial Vertebral Artery Stenosis: The VISTA Trial
Led by Xuanwu Hospital, Beijing · Updated on 2023-09-21
472
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for posterior circulation stroke caused by narrowing (stenosis) of the extracranial vertebral artery. The trial evaluates drug-eluting stenting plus medical therapy versus medical therapy alone for patients who had a stroke or transient ischemic attack (TIA) within 3 months due to 70-99% stenosis in specific artery segments. This government-funded, multicenter, randomized controlled trial addresses previous underpowered studies and aims to assess risks and benefits of these treatments. Participants will be randomly assigned to one of two groups: one receiving sirolimus-eluting stenting plus medical therapy including aspirin, clopidogrel or ticagrelor for 6 months followed by single antiplatelet therapy; the other receiving medical therapy alone with the same medications and schedule. The study is conducted at experienced centers and plans to enroll 472 subjects. The initial follow-up lasts 1 year, with long-term monitoring up to 3 years or more. During the study, participants will undergo assessments to monitor stroke occurrence and complications. The main outcome measures include any fatal or non-fatal stroke within 30 days and ischemic stroke in the treated artery territory up to 1 year. Additional evaluations include stroke severity, recurrence, mortality, and vessel restenosis. Safety and efficacy will be carefully tracked throughout the trial, which is expected to complete its first stage by 2027 and continue follow-up until 2028 or later.
CONDITIONS
Brief Title
Drug-eluting Stenting Versus Medical Treatment for Extracranial Vertebral Artery Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- 70% to 99% stenosis of extracranial vertebral artery (V1-2 segments) confirmed by angiography with target vessel diameter at least 2.5 mm
- History of ischemic stroke (mRS score 3 or less) or transient ischemic attack related to target vessels within 3 months before enrollment
- Presence of at least two atherosclerotic risk factors such as hypertension, high cholesterol, diabetes, smoking, drinking, obesity, or obstructive sleep apnea
- Modified Rankin Scale score of 3 or less
- Voluntary participation with signed consent form
You will not qualify if you...
- Vertebral artery stenosis caused by non-atherosclerotic diseases like arterial dissection, Moyamoya disease, vasculitis, radiation-induced vascular disease, or fibromuscular dysplasia
- Severe stenosis or blockage in tandem extracranial or intracranial arteries of the target vessel
- Previous open surgery or endovascular treatment on the target vessel
- Other cerebrovascular diseases requiring surgery or endovascular therapy
- Recent (within 1 month) surgery or endovascular treatment for other cerebrovascular diseases
- Anatomical features making stenting technically unfeasible
- Unclear responsible vessel for symptoms due to lesions in contralateral vertebral or basilar arteries
- Allergies or contraindications to iodinated contrast or sirolimus
- Stroke within the past 7 days
- Intracranial or subarachnoid hemorrhage within past 6 weeks
- Cardioembolic stroke history or conditions like atrial fibrillation or recent myocardial infarction
- Blood clotting disorders or bleeding tendencies
- Severe illnesses preventing follow-up such as serious infections, severe COPD, cancer, dementia, mental illness, uncontrolled severe hypertension or diabetes
- Pregnant or breastfeeding women
- Other conditions judged by investigators to affect safety or study evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months followed by ongoing mono anti-platelet therapy
Participants receive either drug-eluting stenting plus medical therapy or medical therapy alone with aspirin and clopidogrel or ticagrelor for 6 months followed by mono anti-platelet therapy.
Visits scheduled as per medical therapy protocol during treatment period
Duration - Up to 1 year after treatment initiation
Participants are monitored for stroke, adverse events, and other outcomes up to 1 year after randomization.
Follow-up visits to assess health status and outcomes as scheduled up to 1 year
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University.
Beijing, China, 100053
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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