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

NCT ID: NCT02197559

Last Updated: 2016-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-06-30

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:

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

Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BMS group, DES group

All the participants in this group will be performed with bare-metal stents or drug -eluting stents

DES group

Intervention Type PROCEDURE

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

BMS group

Intervention Type PROCEDURE

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

Interventions

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DES group

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

Intervention Type PROCEDURE

BMS group

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

Intervention Type PROCEDURE

Other Intervention Names

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Drug -eluting stents group Bare-metal stents group

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Feng Ling, M.D.

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China

Locations

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Department of neurosurgery, Xuanwu hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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BEST-VAOS

Identifier Type: -

Identifier Source: org_study_id

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