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

Primary Purpose

Ischemic Stroke, Vertebral Artery Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug-eluting stenting plus aspirin and clopidogrel or ticagrelor
Aspirin and clopidogrel or ticagrelor
mono anti-platelet therapy
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Extracranial vertebral artery stenosis, Drug-eluting stenting, Best medical treatment, Ischemic stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years. Extracranial vertebral artery (V1-2 segments) has 70% to 99% stenosis (NASCET criteria by angiography), and the diameter of the target vessel ≥ 2.5mm. 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). 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). mRS score ≤ 3. Patients or their guardians voluntarily participate of the study and sign the consent form. Exclusion Criteria: Vertebral artery stenosis caused by non-atherosclerotic lesions, including arterial dissection, Moyamoya disease, vasculitis disease, radiation-induced vascular disease, fibromuscular dysplasia, etc. Tandem extracranial or intracranial severe stenosis or occlusion of the target vessel. History of open surgery or endovascular treatment of the target vessel. Other cerebrovascular diseases that require one-stage open surgery or endovascular therapies. Open surgery or endovascular treatment for other cerebrovascular diseases within 1 month. Patients in whom vertebral anatomy was felt to be technically not feasible for vertebral artery stenting (e.g. access problems). 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). Known allergy or contraindication to iodinated contrast media and sirolimus. History of acute ischemic stroke within 7 days. History of intracranial hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or extradural hemorrhage within 6 weeks. 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.). Coagulation dysfunction or hemorrhagic tendency (e.g. INR > 1.5 and/or platelet count < 100×10^9/L). 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). Women who are pregnant or lactating. According to the judgement of the investigator, other situations, influencing the safety and efficacy evaluation, which make the patient not suitable for enrollment.

Sites / Locations

  • Xuanwu Hospital, Capital Medical University.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug-eluting stenting group

Medical group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

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

Full Information

First Posted
May 7, 2023
Last Updated
September 15, 2023
Sponsor
Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT05885932
Brief Title
Drug-eluting Stenting Versus Medical Treatment for Extracranial Vertebral Artery Stenosis
Acronym
VISTA
Official Title
Drug-eluting Stenting Versus Medical Treatment Alone for Patients With Extracranial Vertebral Artery Stenosis: The VISTA Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Vertebral Artery Stenosis
Keywords
Extracranial vertebral artery stenosis, Drug-eluting stenting, Best medical treatment, Ischemic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
472 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug-eluting stenting group
Arm Type
Experimental
Arm Description
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.
Arm Title
Medical group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Drug-eluting stenting plus aspirin and clopidogrel or ticagrelor
Other Intervention Name(s)
Sirolimus-eluting stenting plus dual antiplatelet therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin and clopidogrel or ticagrelor
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
mono anti-platelet therapy
Intervention Description
mono anti-platelet therapy
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Fatal or non-fatal stroke within 30 days
Description
The number of participants who suffer from fatal or non-fatal stroke within 30 days after randomization.
Time Frame
within 30 days
Title
Ischemic stroke in the territory of the target artery beyond 30 days to 1 year
Description
The number of participants who suffer from ischemic stroke in the territory of the target artery beyond 30 days to 1 year.
Time Frame
beyond 30 days to 1 year
Title
Ischemic stroke in the territory of the target artery within 1 year
Description
The number of participants who suffer from ischemic stroke in the territory of the target artery within 1 year.
Time Frame
within 1 year
Title
Crescendo TIA in the territory of the target artery within 1 year
Description
The number of participants who suffer from crescendo TIA in the territory of the target artery within 1 year.
Time Frame
within 1 year
Title
Fatal stroke within 1 year
Description
The number of participants who suffer from fatal stroke within 1 year.
Time Frame
within 1 year
Title
Disabling stroke (defined by a modified Rankin Scale Score of ≥3) within 1 year
Description
The number of participants who suffer from disabling stroke (defined by a modified Rankin Scale Score of ≥3) within 1 year.
Time Frame
within 1 year
Title
Any stroke within 1 year
Description
The number of participants who suffer from any stroke within 1 year.
Time Frame
within 1 year
Title
Any stroke, myocardial infarction or death within 1 year
Description
The number of participants who suffer from any stroke, myocardial infarction or death within 1 year.
Time Frame
within 1 year
Title
All cause mortality within 1 year
Description
The number of participants who die of any cause within 1 year.
Time Frame
within 1 year
Title
Symptomatic cerebral hemorrhage within 1 year
Description
The number of participants who suffer from symptomatic cerebral hemorrhage within 1 year.
Time Frame
within 1 year
Title
Modified Rankin Scale (mRS) score (0-5, higher score refers to a worse outcome)
Description
Modified Rankin Scale (mRS) score at 1 year.
Time Frame
at 1 year
Title
In-stent restenosis (Stenosis ≥ 50%)
Description
In-stent restenosis (Stenosis ≥ 50%) at 1 year. Performing CTA or DSA to evaluate the stenosis degree.
Time Frame
at 1 year

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years. Extracranial vertebral artery (V1-2 segments) has 70% to 99% stenosis (NASCET criteria by angiography), and the diameter of the target vessel ≥ 2.5mm. 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). 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). mRS score ≤ 3. Patients or their guardians voluntarily participate of the study and sign the consent form. Exclusion Criteria: Vertebral artery stenosis caused by non-atherosclerotic lesions, including arterial dissection, Moyamoya disease, vasculitis disease, radiation-induced vascular disease, fibromuscular dysplasia, etc. Tandem extracranial or intracranial severe stenosis or occlusion of the target vessel. History of open surgery or endovascular treatment of the target vessel. Other cerebrovascular diseases that require one-stage open surgery or endovascular therapies. Open surgery or endovascular treatment for other cerebrovascular diseases within 1 month. Patients in whom vertebral anatomy was felt to be technically not feasible for vertebral artery stenting (e.g. access problems). 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). Known allergy or contraindication to iodinated contrast media and sirolimus. History of acute ischemic stroke within 7 days. History of intracranial hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or extradural hemorrhage within 6 weeks. 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.). Coagulation dysfunction or hemorrhagic tendency (e.g. INR > 1.5 and/or platelet count < 100×10^9/L). 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). Women who are pregnant or lactating. According to the judgement of the investigator, other situations, influencing the safety and efficacy evaluation, which make the patient not suitable for enrollment.
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University.
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqun Jiao, Dr.
Phone
13911224991
Email
liqunjiao@sina.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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