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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02197559

Enrollment

168

Registered

2014-07-22

Start date

2014-01-31

Completion date

2016-06-30

Last updated

2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke, restenosis,bare-metal stents, drug -eluting stents

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

Interventions

PROCEDUREDES group

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

PROCEDUREBMS group

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Late loss in lumen diameter in follow-up ≥50%	1 year	Late loss in lumen diameter in follow-up ≥50%
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
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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026