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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197559
• Other study ID #: BEST-VAOS
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: October 21, 2016
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2014
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Procedure:
• DES group
all the participants in this group will be performed with drug -eluting stents
• BMS group
all the participants in this group will be performed with bare-metal stents

Locations

Country	Name	City	State
China	Department of neurosurgery, Xuanwu hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late loss in lumen diameter in follow-up =50%	Late loss in lumen diameter in follow-up =50%	1 year	Yes
Primary	Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs	Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs	30 days	Yes
Primary	Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs	Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs	12 months	Yes
Secondary	brain, gastrointestinal and urinary system bleeding in 12 months follow-up	brain, gastrointestinal and urinary system bleeding in 12 months follow-up	12 months	Yes