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

N/ACompletedNCT02197559

Xuanwu Hospital, Beijing168 enrolled

Overview

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

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: 1. Late loss in lumen diameter in follow-up ≥50% 2. Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs 3. 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

Study Type

OBSERVATIONAL

Enrollment

168

Conditions

Ischemic Stroke

Interventions

DES groupPROCEDURE

all the participants in this group will be performed with drug -eluting stents

BMS groupPROCEDURE

all the participants in this group will be performed with bare-metal stents

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of neurosurgery, Xuanwu hospital

Beijing, China

Outcomes

Primary Outcomes

Late loss in lumen diameter in follow-up ≥50%

Time frame: 1 year

Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs

Time frame: 30 days

Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs

Time frame: 12 months

Secondary Outcomes

brain, gastrointestinal and urinary system bleeding in 12 months follow-up

Time frame: 12 months

Data from ClinicalTrials.gov

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