Comparing drug-eluting stenting to medical treatment for vertebral artery stenosis

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

This study is testing whether a stenting procedure with medication can help people who have had a stroke or mini-stroke from a narrowed vertebral artery feel better compared to just taking medicine.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 472 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing)
• Trial ID: NCT05885932 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of drug-eluting stenting compared to best medical treatment for patients with significant stenosis of the extracranial vertebral artery. It aims to recruit patients who have experienced a stroke or transient ischemic attack due to this condition within the last three months. Participants will be randomly assigned to receive either the stenting procedure along with antiplatelet therapy or medical management alone. The study is designed to address previous trials that were underpowered and inconclusive regarding the benefits of stenting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with 70-99% stenosis of the extracranial vertebral artery and a history of stroke or TIA within the last three months.

Not a fit: Patients with vertebral artery stenosis due to non-atherosclerotic causes or those with severe tandem stenosis or occlusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from ischemic strokes related to vertebral artery stenosis.

How similar studies have performed: Previous studies on vertebral artery stenting have shown inconclusive results, indicating that this approach is still being explored and may provide new insights.

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.

Where this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University. — Beijing, China (Recruiting)

Conditions Ischemic Stroke; Vertebral Artery Stenosis; Extracranial vertebral artery stenosis; Drug-eluting stenting; Best medical treatment; Ischemic stroke