Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study

Study Overview
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Brief Summary
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There are two arms in our trial, DCB group, BMS group.The investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months.

Official Title
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Chinese Society of Interventional Radiology

Conditions
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Vertebral Artery Origin Stenosis

Intervention / Treatment
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* Device: drug-coated balloon
* Device: bare metal stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 18 and 80 years old; TIA or non-disabling ischaemic stroke of the posterior circulation; symptoms occurred in the 14 days and could not be relieved after 2 months of regular medication stenosis of the vertebral artery of 50% or greater, diagnosed by both CT angiography or angiography; NIHSS≤ 6; score on the modified Rankin scale ≤ 3. Exclusion Criteria: Active bleeding or coagulation disorders or severe renal/liver impairment allergy to iodinated contrast agent or related medicines; acute stroke in 3 weeks more than 1 stenosis at the target vessel or Distal vascular dysplasia (diameter≤3mm) a potential cause of stenosis other than atherosclerosis Severe stenosis was found in the anterior circulation artery(>70%) intracranial hemorrhage or hemorrhagic stroke, intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm in 30 days; ISR patients; Severe calcification lesion； obvious thrombosis in vessel; pregnancy; a potential cause of TIA or minor stroke other than stenosis in a vertebral artery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| drug-coated balloon<br>patients with vertebral artery origin stenosis treated with drug-coated balloons | Device: drug-coated balloon<br>* Orchid and Dahlia DCB<br>|
| bare metal stent<br>patients with vertebral artery origin stenosis treated with bare metal stent | Device: bare metal stent<br>* any type of bare metal stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months | vascular death,non-fatal myocardial and non-fatal stroke diagnosed by specialist physician | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lumen loss at 6 months | lumen loss measured by doppler untrasound | 6 months | 
| lumen loss at 12 months | lumen loss measured by doppler untrasound | 12 months | 
| restenosis at 6 months | restenosis was assessed by doppler untrasound | 6 months | 
| restenosis at 12 months | restenosis was assessed by doppler untrasound | 12 months | 
| traget lesion revascularizition at 12 months | traget lesion revascularizition including envascular intervention and Surgery | 12 months | 
| Incidence of safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke in 30 days | safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke diagnosed by investigators within 30 days after start of the treatment | 30 days | 
| stent fracture rate at 12 months | stent fracture was assessed by DSA | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vertebral artery origin stenosis, drug-coated balloon, stenting, medical treatment