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NCT Number: NCT02197559

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

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of neurosurgery, Xuanwu hospital

Beijing, 100053, China

About this study

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:

  • Late loss in lumen diameter in follow-up ≥50%
  • 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

Secondary endpoint:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DES group

Procedure

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

Other names: Drug -eluting stents group

BMS group

Procedure

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

Other names: Bare-metal stents group

Primary outcomes

  1. Late loss in lumen diameter in follow-up ≥50%

    Time frame: 1 year

    Late loss in lumen diameter in follow-up ≥50%

  2. Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs

    Time frame: 30 days

    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

    Time frame: 12 months

    Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs

Secondary outcomes

  1. brain, gastrointestinal and urinary system bleeding in 12 months follow-up

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 22, 2014
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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