Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis

Study Overview
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Brief Summary
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The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis than Bare-metal stents after Vertebral Artery Ostium stenting

Detailed Description
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The vertebral artery ostium stenosis was one of the higher risk of the ischemia stroke in China. In the mean time ,more and more people accept revascularization. There are no prospective studies for comparison of prevention of restenosis after Drug -eluting stents and Bare-metal stents until now. The main aim of this study is to observe the following details: Late loss in lumen diameter in follow-up ≥50% Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs Secondary endpoint: brain, gastrointestinal and urinary system bleeding in 12 months follow-up

Official Title
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A Prospectie Cohort Study of Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Procedure: DES group
* Procedure: BMS group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - symptomatic posterior circulation ischemia including monor stroke (mRS ≤2) or TIA result from the stenosis in the vertebral artery ostium. 70% to 99% stenosis of vertebral artery ostium. Exclusion Criteria: etiology of stenotic lesions not atherosclerosis patients had undergone previos interventions on the vertebral artery ostium ipsilateral severe stenotic lesions in subclavian artery involved as well as vertebral artery ostium

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 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 |
| --- | --- |
| BMS group, DES group<br>All the participants in this group will be performed with bare-metal stents or drug -eluting stents | Procedure: DES group<br>* all the participants in this group will be performed with drug -eluting stents<br>* Other names: Drug -eluting stents group;Procedure: BMS group<br>* all the participants in this group will be performed with bare-metal stents<br>* Other names: Bare-metal stents group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late loss in lumen diameter in follow-up ≥50% | Late loss in lumen diameter in follow-up ≥50% | 1 year | 
| Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs | Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs | 30 days | 
| Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs | Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain, gastrointestinal and urinary system bleeding in 12 months follow-up | brain, gastrointestinal and urinary system bleeding in 12 months follow-up | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Stroke, restenosis,bare-metal stents, drug -eluting stents