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

September 15, 2023 updated by: Xuanwu Hospital, Beijing

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

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

472

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug-eluting stenting group
All the participants in this group will be performed with extracranial vertebral artery sirolimus-eluting stenting plus best medical treatment including Aspirin 100mg per day + Clopidogrel 75mg per day or Ticagrelor 90mg twice per day for 6 months and mono anti-platelet therapy thereafter.
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.
Other Names:
  • Sirolimus-eluting stenting plus dual antiplatelet therapy
Active Comparator: Medical group
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.
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.
mono anti-platelet therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The number of participants who suffer from 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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatal or non-fatal stroke within 30 days
Time Frame: within 30 days
The number of participants who suffer from fatal or non-fatal stroke within 30 days after randomization.
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
The number of participants who suffer from ischemic stroke in the territory of the target artery beyond 30 days to 1 year.
beyond 30 days to 1 year
Ischemic stroke in the territory of the target artery within 1 year
Time Frame: within 1 year
The number of participants who suffer from ischemic stroke in the territory of the target artery within 1 year.
within 1 year
Crescendo TIA in the territory of the target artery within 1 year
Time Frame: within 1 year
The number of participants who suffer from crescendo TIA in the territory of the target artery within 1 year.
within 1 year
Fatal stroke within 1 year
Time Frame: within 1 year
The number of participants who suffer from fatal stroke within 1 year.
within 1 year
Disabling stroke (defined by a modified Rankin Scale Score of ≥3) within 1 year
Time Frame: within 1 year
The number of participants who suffer from disabling stroke (defined by a modified Rankin Scale Score of ≥3) within 1 year.
within 1 year
Any stroke within 1 year
Time Frame: within 1 year
The number of participants who suffer from any stroke within 1 year.
within 1 year
Any stroke, myocardial infarction or death within 1 year
Time Frame: within 1 year
The number of participants who suffer from any stroke, myocardial infarction or death within 1 year.
within 1 year
All cause mortality within 1 year
Time Frame: within 1 year
The number of participants who die of any cause within 1 year.
within 1 year
Symptomatic cerebral hemorrhage within 1 year
Time Frame: within 1 year
The number of participants who suffer from symptomatic cerebral hemorrhage within 1 year.
within 1 year
Modified Rankin Scale (mRS) score (0-5, higher score refers to a worse outcome)
Time Frame: at 1 year
Modified Rankin Scale (mRS) score at 1 year.
at 1 year
In-stent restenosis (Stenosis ≥ 50%)
Time Frame: at 1 year
In-stent restenosis (Stenosis ≥ 50%) at 1 year. Performing CTA or DSA to evaluate the stenosis degree.
at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

May 7, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

May 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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