A Prospectie Cohort Study of Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Late loss in lumen diameter in follow-up ≥50%
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis than Bare-metal stents after Vertebral Artery Ostium stenting
Detailed Description
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Late loss in lumen diameter in follow-up ≥50%
Time Frame: 1 year
Late loss in lumen diameter in follow-up ≥50%
Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Time Frame: 12 months
Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
Time Frame: 30 days
Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
Secondary Outcomes
- brain, gastrointestinal and urinary system bleeding in 12 months follow-up(12 months)