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Completed

NCT Number: NCT03201432

Drug Eluting Stents Versus Bare Metal Stents for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis

Stroke is one of the important causes of disability and death in the world, in which more than half were ischemic strokes. About 1/4 of the ischemic stroke occurred in the vertebral basilar artery system, especially when in the presence of extracranial proximal vertebral artery stenosis. Vertebral artery stenting is a minimally invasive method for the reconstruction of vertebral artery stenosis and the early clinical studies showed that it was feasible, safe and effective, but the high rate of restenosis has become a bottleneck restricting its development. Previous systematic review had suggested that the drug eluting stent might reduce the incidence of restenosis of vertebral artery. However, prospective randomized controlled trials comparing the efficacy of bare metal stents and drug eluting stents on the prevention of restenosis remains absent.

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Key information

About this study

60 patients were randomly assigned into DES and BES group to compare the safety and efficacy in the treatment of symptomatic extracranial vertebral artery stenosis with drug eluting stents (YINYI) and bare metal stents (Express SD), especially the stent restenosis rate after 6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic posterior circulation ischemia(Vertebral basilar artery system TIA or non-disabling ischemic stroke)result from the stenosis in the extracranial proximal vertebral artery stenosis.
  • Atherosclerotic extracranial proximal vertebral artery stenosis demonstrated by angiography(any of the following): 1) bilateral vertebral artery stenosis ≥70%, or vertebral artery stenosis ≥70% concomitant occlusion of contralateral vertebral artery; 2) superior lateral vertebral artery stenosis ≥70%; 3) non-superior lateral vertebral artery stenosis ≥50%, but the vertebral artery was directly extended to the posterior inferior cerebellar artery on this side and symptoms were related to insufficiency of the ipsilateral posterior inferior cerebellar artery.

Exclusion criteria

  • 1) lesions characteristics (such as diffuse lesions) which was not suitable for interventional treatment, or unstable condition that cannot tolerate the interventional therapy;
  • 2) vertebral artery stenosis caused by non atherosclerosis disease: Takayasu arteritis or other diseases;
  • 3) severe stroke within 3 months;
  • 4) contraindicated using contrast agents: such as chronic renal insufficiency or had serious contrast agents allergy history;
  • 5) malignant tumor;
  • 6) with Alzheimer's disease or mental illness previously or currently ;
  • 7) patients or family members refuse the operation.

Treatment and study plan

Drug Eluting Stent (DES)

Device

Polymer-free paclitaxel eluting stents

Other names: YINYI (Liaoning Biomedical Materials R&D Center Co., Ltd.)

Bare metal stent (BES)

Device

Bare metal stent

Other names: Express SD (Bosten Scientific)

Primary outcomes

  1. Stent restenosis rate 6 months after stenting

    Time frame: 6 months

Secondary outcomes

  1. Stent restenosis rate 3 months after stenting

    Time frame: 3 months

  2. Stent restenosis rate 12 months after stenting

    Time frame: 12 months

    measured by ultrasound

  3. The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Xiongjing Jiang

Other

Collaborators

  • Yinyi(Liaoning) Biotech Co., Ltd.

Registry information

Official study title

A Randomized Trial for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis: Drug Eluting Stents Versus Bare Metal Stents

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2017
Registry last updated
Jun 28, 2017

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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