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

Launched by XUANWU HOSPITAL, BEIJING · Jun 1, 2023

Keywords

ClinConnect Summary

The VISTA trial is a study that compares two different treatments for people who have a narrowing of the vertebral artery, which can lead to strokes. Specifically, the trial looks at whether a procedure called drug-eluting stenting, where a small tube is placed to keep the artery open, is more effective than just using medication to manage the condition. This study is important because previous research did not find clear answers about the best approach. To participate, individuals must be at least 18 years old, have significant narrowing of the artery (70-99%), and have experienced a stroke or a mini-stroke within the last three months.

Participants in the trial will be divided into two groups: one will receive the best medical treatment available, while the other will receive medical treatment along with the stenting procedure. The main goal is to see if either treatment reduces the risk of having another stroke in the first year after starting the study. The trial aims to enroll 472 participants across 30 locations in China, and recruitment is expected to finish by September 2025. After the initial year, participants will be followed for longer to gather more information on the long-term effects of the treatments.

Gender

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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.