Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis

Study Overview
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Brief Summary
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Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be treated with stenting. However, in-stent restenosis rate have been reported as high as more than 30%, which may reduce the effect of stent therapy. Drug-coated balloon has shown good results in controlling neointimal hyperplasia in the femoral and popliteal arteries.

Official Title
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Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis

Conditions
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Vertebral Artery Stenosis

Intervention / Treatment
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* Device: Drug-coated balloon angioplasty
* Device: stenting angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Patients presenting with posterior circulation transient ischemic attack or nondisabling stroke in the previous 6 months Vertebral artery origin stenosis resulting from presumed atheromatous disease with stenosis ≥50% Lesion length of the stenosis >5mm. Angioplasty can be performed within two weeks after randomization Female subjects of childbearing potential have a negative pregnancy test. Signed informed consent prior to entering study Exclusion Criteria: Potential cause of TIA or minor stroke other than stenosis in a vertebral artery (e.g. atrial fibrillation) Life expectancy shorter than 2 years Vertebral artery stenosis caused by dissection Vertebral stenting felt to be technically impracticable Previous stenting in randomized artery Pre-morbid modified Rankin scale score of greater than 3 Currently participating or previously participated in any investigational drug or device study within 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-coated balloon angioplasty<br> | Device: Drug-coated balloon angioplasty<br>* Angioplasty with a drug-coated angioplasty<br>|
| Active Comparator: stenting angioplasty<br> | Device: stenting angioplasty<br>* Angioplasty with a stenting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of vascular death, myocardial infarction, or any stroke |  | within 30 days after the start of treatment | 
| The composite of vascular death, myocardial infarction, or any stroke |  | within 12 months after the start of treatment | 
| Death resulting from any cause |  | 12 months | 
| Stroke in the supply territory of the symptomatic vertebral artery |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vertebral Artery Stenosis, Drug-coated balloon angioplasty, Stenting