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

Completed

• Conditions: Ischemic Stroke
• Interventions: Procedure: DES group; Procedure: BMS group

• Registration Number: NCT02197559
• Lead Sponsor: Xuanwu Hospital, Beijing

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

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-07
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Primary Completion: 2015-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BMS group, DES group	DES group	All the participants in this group will be performed with bare-metal stents or drug -eluting stents
BMS group, DES group	BMS group	All the participants in this group will be performed with bare-metal stents or drug -eluting stents

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of neurosurgery, Xuanwu hospital; 🇨🇳 Beijing, China