xml: <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/NCT06014723</url>
    </required_header>
    <id_info>
      <org_study_id>BLAST</org_study_id>
      <nct_id>NCT06014723</nct_id>
    </id_info>
    <brief_title>Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA</brief_title>
    <official_title>Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shouchun Wang, MD, PhD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The General Hospital of Northern Theater Command</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The First Hospital of Jilin University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study was to evaluate the safety and efficacy of early submaximal&#xD;
        balloon angioplasty combined with medical therapy vs medical therapy alone for minor&#xD;
        stroke/transient ischemic attack with intracranial atherosclerosis etiology.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, 416 patients with minor strokes or transient ischemic attacks due to&#xD;
        symptomatic intracranial atherosclerotic stenosis within one week of the onset of last&#xD;
        ischemic symptoms from 20 centers in China were enrolled. The observation group received&#xD;
        early submaximal balloon angioplasty, while the control group received only medical therapy.&#xD;
        Two groups will be followed up for 1 year to evaluate the safety and efficacy of early&#xD;
        submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for&#xD;
        minor stroke / transient ischemic attack with intracranial atherosclerosis etiology.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2026</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>Stroke or death within 30 days after enrollment, or ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment.</measure>
      <time_frame>30 days, 1 year</time_frame>
      <description>Stroke or death within 30 days after enrollment, or ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Stroke or death within 30 days after enrollment</measure>
      <time_frame>30 days</time_frame>
      <description>Stroke or death within 30 days after enrollment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment</measure>
      <time_frame>1 year</time_frame>
      <description>Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Restenosis rate of criminal artery within 1 year after enrollment</measure>
      <time_frame>1 year</time_frame>
      <description>Restenosis rate of criminal artery within 1 year after enrollment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of neurological function improvement within 90 days of enrollment</measure>
      <time_frame>90 days</time_frame>
      <description>Evaluation of neurological function improvement within 90 days of enrollment</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Intracranial hemorrhage within 30 days of enrollment</measure>
      <time_frame>30 days</time_frame>
      <description>Intracranial hemorrhage within 30 days of enrollment</description>
    </other_outcome>
    <other_outcome>
      <measure>Complications associated with endovascular therapy</measure>
      <time_frame>24 hours, discharge, 30 days, 90 days, and 1 year after enrollment</time_frame>
      <description>Complications associated with endovascular therapy</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">416</enrollment>
    <condition>Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>Observation group</arm_group_label>
      <description>The observation group received early submaximal balloon angioplasty and medical therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>The control group received only medical therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Submaximal balloon angioplasty</intervention_name>
      <description>The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.</description>
      <arm_group_label>Observation group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with minor stroke/transient ischemic attack.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The age range is 30-80 years old;&#xD;
  &#xD;
            2. Symptomatic atherosclerotic large artery stenosis in intracranial segments and 70-99%&#xD;
               stenosis confirmed by DSA;&#xD;
  &#xD;
            3. Minor stroke (NIHSS score ≤5) or intermediate- to high-risk TIA within 1 week of&#xD;
               onset, with intermediate- to high-risk TIA defined as ABCD2 score ≥4;&#xD;
  &#xD;
            4. The diameter of the criminal artery ranged from 2.0 to 4.5mm, and the length of the&#xD;
               stenosis of the criminal artery ranged from less than 14mm;&#xD;
  &#xD;
            5. mRS ≤ 2 before endovascular treatment；&#xD;
  &#xD;
            6. No large ischemic region was found on CT or MRI；&#xD;
  &#xD;
            7. Written informed consent obtained from the patient or legally responsible person.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Allergy to contrast media;&#xD;
  &#xD;
            2. Non-atherosclerotic disease-related stenosis: arterial dissection, Moya-Moya disease,&#xD;
               arteritis, etc;&#xD;
  &#xD;
            3. Penetrating branch lesion;&#xD;
  &#xD;
            4. Presence of severe stenosis of the extracranial segment on the side of the target&#xD;
               lesion;&#xD;
  &#xD;
            5. Previous endovascular treatment of the ipsilateral vessel was performed;&#xD;
  &#xD;
            6. Presence of intracranial aneurysms, tumors, and vascular malformations;&#xD;
  &#xD;
            7. Any form of ipsilateral intracranial hemorrhage within 3 months and contralateral&#xD;
               intracranial hemorrhage within 2 weeks;&#xD;
  &#xD;
            8. Combined with atrial fibrillation, severe heart function, liver or kidney dysfunction;&#xD;
               patients with tumors and serious diseases whose expected survival time is less than 1&#xD;
               year;&#xD;
  &#xD;
            9. Hemoglobin less than 100g/L, platelet count less than 100×10^9/L, international&#xD;
               standardized ratio (INR) &gt; 1.5 (irreversible), coagulopathy or irremediable bleeding&#xD;
               factors;&#xD;
  &#xD;
           10. Uncontrollable hypertension: systolic blood pressure &gt;185 mmHg and or diastolic blood&#xD;
               pressure &gt;110 mmHg;&#xD;
  &#xD;
           11. Poor glycaemic control (random blood glucose &gt; 22.2 mmol/L);&#xD;
  &#xD;
           12. History of major surgery within 30 days prior to enrollment or surgery plan within 90&#xD;
               days after enrollment;&#xD;
  &#xD;
           13. Pregnancy or lactation;&#xD;
  &#xD;
           14. Other conditions that the researchers think the patient unsuitable for the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Shouchun Wang, MD, PhD</last_name>
      <phone>0086-13596060906</phone>
      <email>WSC@jlu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Huisheng Chen, MD, PhD</last_name>
      <phone>0086-13352452086</phone>
      <email>chszh@aliyun.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
      <investigator_full_name>Shouchun Wang, MD, PhD</investigator_full_name>
      <investigator_title>Chief physician of the Department of Neurology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014723
  org study id: BLAST
  nct id: NCT06014723
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study was to evaluate the safety and efficacy of early submaximal
        balloon angioplasty combined with medical therapy vs medical therapy alone for minor
        stroke/transient ischemic attack with intracranial atherosclerosis etiology.
  In this study, 416 patients with minor strokes or transient ischemic attacks due to
        symptomatic intracranial atherosclerotic stenosis within one week of the onset of last
        ischemic symptoms from 20 centers in China were enrolled. The observation group received
        early submaximal balloon angioplasty, while the control group received only medical therapy.
        Two groups will be followed up for 1 year to evaluate the safety and efficacy of early
        submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for
        minor stroke / transient ischemic attack with intracranial atherosclerosis etiology.
  observational model: Cohort
  time perspective: Prospective
  measure: Stroke or death within 30 days after enrollment, or ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment.
  time frame: 30 days, 1 year
  description: Stroke or death within 30 days after enrollment, or ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment.
  measure: Stroke or death within 30 days after enrollment
  time frame: 30 days
  description: Stroke or death within 30 days after enrollment
  measure: Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment
  time frame: 1 year
  description: Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment
  measure: Restenosis rate of criminal artery within 1 year after enrollment
  time frame: 1 year
  description: Restenosis rate of criminal artery within 1 year after enrollment
  measure: Evaluation of neurological function improvement within 90 days of enrollment
  time frame: 90 days
  description: Evaluation of neurological function improvement within 90 days of enrollment
  measure: Intracranial hemorrhage within 30 days of enrollment
  time frame: 30 days
  description: Intracranial hemorrhage within 30 days of enrollment
  measure: Complications associated with endovascular therapy
  time frame: 24 hours, discharge, 30 days, 90 days, and 1 year after enrollment
  description: Complications associated with endovascular therapy
  arm group label: Observation group
  description: The observation group received early submaximal balloon angioplasty and medical therapy.
  arm group label: Control group
  description: The control group received only medical therapy.
  intervention type: Procedure
  intervention name: Submaximal balloon angioplasty
  description: The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.
  arm group label: Observation group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 80 Years
  last name: Shouchun Wang, MD, PhD
  phone: 0086-13596060906
  email: WSC@jlu.edu.cn
  last name: Huisheng Chen, MD, PhD
  phone: 0086-13352452086
  email: chszh@aliyun.com
  responsible party type: Sponsor-Investigator
  investigator affiliation: The First Hospital of Jilin University
  investigator full name: Shouchun Wang, MD, PhD
  investigator title: Chief physician of the Department of Neurology
  mesh term: Stroke
  mesh term: Ischemic Stroke