<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02197559</url>
  </required_header>
  <id_info>
    <org_study_id>BEST-VAOS</org_study_id>
    <nct_id>NCT02197559</nct_id>
  </id_info>
  <brief_title>Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis</brief_title>
  <official_title>A Prospectie Cohort Study of Bare -Metal Stents and Drug -Eluting Stents in the Treatment of Patients With Vertebral Artery Ostium Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xuanwu Hospital, Beijing</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis&#xD;
      than Bare-metal stents after Vertebral Artery Ostium stenting&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The vertebral artery ostium stenosis was one of the higher risk of the ischemia stroke in&#xD;
      China. In the mean time ,more and more people accept revascularization. There are no&#xD;
      prospective studies for comparison of prevention of restenosis after Drug -eluting stents and&#xD;
      Bare-metal stents until now.&#xD;
&#xD;
      The main aim of this study is to observe the following details:&#xD;
&#xD;
        1. Late loss in lumen diameter in follow-up ≥50%&#xD;
&#xD;
        2. Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet&#xD;
           drugs&#xD;
&#xD;
        3. Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet&#xD;
           drugs&#xD;
&#xD;
      Secondary endpoint:&#xD;
&#xD;
      brain, gastrointestinal and urinary system bleeding in 12 months follow-up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Late loss in lumen diameter in follow-up ≥50%</measure>
    <time_frame>1 year</time_frame>
    <description>Late loss in lumen diameter in follow-up ≥50%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs</measure>
    <time_frame>30 days</time_frame>
    <description>Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs</measure>
    <time_frame>12 months</time_frame>
    <description>Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>brain, gastrointestinal and urinary system bleeding in 12 months follow-up</measure>
    <time_frame>12 months</time_frame>
    <description>brain, gastrointestinal and urinary system bleeding in 12 months follow-up</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">168</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>BMS group, DES group</arm_group_label>
    <description>All the participants in this group will be performed with bare-metal stents or drug -eluting stents</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>DES group</intervention_name>
    <description>all the participants in this group will be performed with drug -eluting stents</description>
    <arm_group_label>BMS group, DES group</arm_group_label>
    <other_name>Drug -eluting stents group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>BMS group</intervention_name>
    <description>all the participants in this group will be performed with bare-metal stents</description>
    <arm_group_label>BMS group, DES group</arm_group_label>
    <other_name>Bare-metal stents group</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Symptomatic status: as evidenced by TIA or non-severe stroke within the past 12 months&#xD;
        attributed to 70% to 99% stenosis of vertebral artery ostium are eligible. Degree of&#xD;
        stenosis: &gt;70% and &lt;99%; stenosis may be diagnosed by TCD, MRA, or CTA to qualify for&#xD;
        angiogram performed as part of the study protocol, but must be confirmed by catheter&#xD;
        angiography for enrollment in the trial. All the patients should be performed with PTAS&#xD;
        beyond a duration of 3 weeks from the latest ischemic symptom onset. No fresh infarctions&#xD;
        identified on MRI (indicated as high signals on DWI series) upon enrollment.Patient is&#xD;
        willing and able to return for all follow-up visits required by the protocol Patient&#xD;
        understands the purpose and requirements of the study, can make him/herself understood, and&#xD;
        has signed informed consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - symptomatic posterior circulation ischemia including monor stroke (mRS ≤2) or TIA result&#xD;
        from the stenosis in the vertebral artery ostium.&#xD;
&#xD;
        70% to 99% stenosis of vertebral artery ostium.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  etiology of stenotic lesions not atherosclerosis patients had undergone previos&#xD;
             interventions on the vertebral artery ostium ipsilateral severe stenotic lesions in&#xD;
             subclavian artery involved as well as vertebral artery ostium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Feng Ling, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of neurosurgery, Xuanwu hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>October 21, 2016</last_update_submitted>
  <last_update_submitted_qc>October 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ischemic Stroke, restenosis,bare-metal stents, drug -eluting stents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02197559
org study id: BEST-VAOS
nct id: NCT02197559
lead sponsor: 
has dmc: Yes
The study hypothesizes that Drug -eluting stents are more effective in preventing restenosis
      than Bare-metal stents after Vertebral Artery Ostium stenting
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
observational model: Cohort
time perspective: Prospective
measure: Late loss in lumen diameter in follow-up ≥50%
time frame: 1 year
description: Late loss in lumen diameter in follow-up ≥50%
measure: Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
time frame: 30 days
description: Death, non -fatal stroke 30 days after stent implantation associated with antiplatelet drugs
measure: Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
time frame: 12 months
description: Death, non -fatal stroke 12 months after stent implantation associated with antiplatelet drugs
measure: brain, gastrointestinal and urinary system bleeding in 12 months follow-up
time frame: 12 months
description: brain, gastrointestinal and urinary system bleeding in 12 months follow-up
arm group label: BMS group, DES group
description: All the participants in this group will be performed with bare-metal stents or drug -eluting stents
intervention type: Procedure
intervention name: DES group
description: all the participants in this group will be performed with drug -eluting stents
arm group label: BMS group, DES group
other name: Drug -eluting stents group
intervention type: Procedure
intervention name: BMS group
description: all the participants in this group will be performed with bare-metal stents
arm group label: BMS group, DES group
other name: Bare-metal stents group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: No
last name: Feng Ling, M.D.
role: Principal Investigator
affiliation: Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China
facility: 
country: China
responsible party type: Sponsor
mesh term: Ischemic Stroke