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

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

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Procedure: DES group; Procedure: BMS group

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 Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Department of Neurosurgery, Xuanwu hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Symptomatic status: as evidenced by TIA or non-severe stroke within the past 12 months attributed to 70% to 99% stenosis of vertebral artery ostium are eligible. Degree of stenosis: >70% and <99%; stenosis may be diagnosed by TCD, MRA, or CTA to qualify for angiogram performed as part of the study protocol, but must be confirmed by catheter angiography for enrollment in the trial. All the patients should be performed with PTAS beyond a duration of 3 weeks from the latest ischemic symptom onset. No fresh infarctions identified on MRI (indicated as high signals on DWI series) upon enrollment.Patient is willing and able to return for all follow-up visits required by the protocol Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BMS group, DES group; All the participants in this group will be performed with bare-metal stents or drug -eluting stents	Procedure: DES group; all the participants in this group will be performed with drug -eluting stents; Other Names: Drug -eluting stents group; Procedure: BMS group; all the participants in this group will be performed with bare-metal stents; Other Names: Bare-metal stents group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Feng Ling, M.D., Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 22, 2014

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Ischemic Stroke, restenosis,bare-metal stents, drug -eluting stents
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: BEST-VAOS