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

Primary Purpose

Ischemic Stroke, Vertebral Artery Stenosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Drug eluting stent (DES)
Bare metal stent (BES)
Sponsored by
Xiongjing Jiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Vertebral Artery Stenosis, Ischemic Stroke, Stent

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Bare metal stent (BES) group

    Drug eluting stent (DES) group

    Arm Description

    Percutaneous vertebral artery stenting using bare metal stents (Boston Scientific：Express SD) in patients randomized to BES group

    Percutaneous vertebral artery stenting using drug eluting stents (Liaoning Biomedical Materials R&D Center Co., Ltd. ：YINYI) in patients randomized to DES group

    Outcomes

    Primary Outcome Measures

    Stent restenosis rate 6 months after stenting

    Secondary Outcome Measures

    Stent restenosis rate 3 months after stenting
    Stent restenosis rate 12 months after stenting
    measured by ultrasound
    The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting

    Full Information

    First Posted
    March 4, 2016
    Last Updated
    June 25, 2017
    Sponsor
    Xiongjing Jiang
    Collaborators
    Yinyi(Liaoning) Biotech Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03201432
    Brief Title
    Drug Eluting Stents Versus Bare Metal Stents for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis
    Official Title
    A Randomized Trial for Treatment of Symptomatic Extracranial Vertebral Artery Stenosis: Drug Eluting Stents Versus Bare Metal Stents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Xiongjing Jiang
    Collaborators
    Yinyi(Liaoning) Biotech Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke, Vertebral Artery Stenosis
    Keywords
    Vertebral Artery Stenosis, Ischemic Stroke, Stent

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Masking Description
    No Masking
    Allocation
    Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bare metal stent (BES) group
    Arm Type
    Other
    Arm Description
    Percutaneous vertebral artery stenting using bare metal stents (Boston Scientific：Express SD) in patients randomized to BES group
    Arm Title
    Drug eluting stent (DES) group
    Arm Type
    Experimental
    Arm Description
    Percutaneous vertebral artery stenting using drug eluting stents (Liaoning Biomedical Materials R&D Center Co., Ltd. ：YINYI) in patients randomized to DES group
    Intervention Type
    Device
    Intervention Name(s)
    Drug eluting stent (DES)
    Other Intervention Name(s)
    YINYI (Liaoning Biomedical Materials R&D Center Co., Ltd.)
    Intervention Description
    Polymer-free paclitaxel eluting stents
    Intervention Type
    Device
    Intervention Name(s)
    Bare metal stent (BES)
    Other Intervention Name(s)
    Express SD (Bosten Scientific)
    Intervention Description
    Bare metal stent
    Primary Outcome Measure Information:
    Title
    Stent restenosis rate 6 months after stenting
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Stent restenosis rate 3 months after stenting
    Time Frame
    3 months
    Title
    Stent restenosis rate 12 months after stenting
    Description
    measured by ultrasound
    Time Frame
    12 months
    Title
    The incidence of cardiovascular events (stroke, TIA, Miocardial infarction and death) 6 months after stenting
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiongjing Jiang, M.D.
    Organizational Affiliation
    Chinese Academy of Medical Sciences, Fuwai Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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