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/NCT05999669</url>
    </required_header>
    <id_info>
      <org_study_id>GLASS-EVT</org_study_id>
      <nct_id>NCT05999669</nct_id>
    </id_info>
    <brief_title>Predictive Value of the Global Limb Anatomic Staging System (GLASS) in Patients With Critical Limb-threatening Ischemia</brief_title>
    <official_title>Assessing the Predictive Value of the Global Limb Anatomic Staging System (GLASS) in EndoVascular Therapy (EVT) of Infrainguinal Lesions in Patients With Critical Limb-threatening Ischemia (CLTI): the GLASS-EVT Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Xuanwu Hospital, Beijing</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Second Affiliated Hospital of Soochow University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First People's Hospital of Hangzhou</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Qingdao haici hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Huashan Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xiamen Cardiovascular Hospital, Xiamen University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Chengdu University of Traditional Chinese Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>RenJi Hospital</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 Global Vascular Guideline on chronic limb threatening ischemia (CLTI) proposes the Global&#xD;
        Limb Anatomic Staging System (GLASS), a new angiographic scoring system to quantify the&#xD;
        anatomic severity of infrainguinal disease in CLTI patients. However, GLASS validation still&#xD;
        needs to be completed, and the infrapopliteal (IP) target artery pathway (TAP) was easily&#xD;
        influenced by the procedures. Thus the IP target artery could be selected either as the least&#xD;
        diseased artery based on angiography or prospectively based on the angiosome concept. So the&#xD;
        investigators aim to evaluate its correlation with clinical outcomes after revascularization.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) recommends using&#xD;
        the Global Limb Anatomic Staging System (GLASS) to assess the severity of infrainguinal&#xD;
        disease in CLTI patients. GLASS staging involves scoring the femoropopliteal (FP) and&#xD;
        infrapopliteal (IP) segments separately. For IP segment scoring, the target artery path (TAP)&#xD;
        is identified by the clinician based on either the least diseased or the recanalized IP path.&#xD;
        However, this approach may lead to diverse GLASS staging results, especially for simple&#xD;
        lesions below the knee. Additionally, the current version of GLASS does not account for&#xD;
        multivessel IP revascularization, which may introduce subjective bias if a physician chooses&#xD;
        different IP targets during multiple revascularization procedures.&#xD;
  &#xD;
        In order to improve our understanding of the current staging system, the investigators will&#xD;
        establish a prospective registry that collects data on conservative patients who have Chronic&#xD;
        Limb-Threatening Ischemia (CLTI) and undergo endovascular therapy for infrainguinal lesions.&#xD;
        To evaluate the stage of the lesions, the investigators will use two distinct IP scoring&#xD;
        techniques. One approach will be based on the least disease IP path as identified by the&#xD;
        pre-interventional angiogram, while the second technique will be based on the recanalized IP&#xD;
        path preferred by the clinician. This scoring will be carried out by experienced physicians&#xD;
        and the results will be recorded in an electronic database. Then the correlation between the&#xD;
        major adverse limb events (such as clinical-driven target limb revascularization, major&#xD;
        amputation, and all-cause death) with the patient's Wound, Ischemia, foot Infection (WIFI)&#xD;
        classification, GLASS anatomic staging, calcification severity, and modified Society for&#xD;
        Vascular Surgery (SVS) run-off score will be analyzed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Rate of freedom from major adverse events (MAEs)</measure>
      <time_frame>12-month</time_frame>
      <description>Major adverse events (MAEs) is defined as index limb amputation above the ankle, clinical-driven target lesion revascularization (CD-TLR), or all-cause death</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of acute procedure success</measure>
      <time_frame>72-hour after procedure</time_frame>
      <description>Acute procedure success is defined as technique success ( the achievement of final residual diameter stenosis &lt;30% for stent and &lt;50% for angioplasty or atherectomy by angiography at the end of the procedure and without flow-limiting arterial dissection or hemodynamically significant trans-lesional pressure gradient &lt;10 mm Hg for endovascular revascularization ) and freedom form MAEs within 72 hours of the index procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of freedom from clinical-driven target lesion revascularization (CD-TLR)</measure>
      <time_frame>24-month</time_frame>
      <description>Patients without clinical-driven target lesion revascularization (CD-TLR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of freedom from major adverse events (MAEs)</measure>
      <time_frame>24-month</time_frame>
      <description>Major adverse events (MAEs) is defined as index limb amputation above the ankle, clinical-driven target lesion revascularization (CD-TLR), or all-cause death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Primary sustained clinical improvement assessed by Rutherford classification</measure>
      <time_frame>24-month</time_frame>
      <description>Primary sustained clinical improvement is defined as an upward shift on the Rutherford classification to a level of claudication without the need for repeated target lesion revascularization in surviving patients without the need for unplanned amputation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of quality of life assessed by Vasc quality of life scale</measure>
      <time_frame>24-month</time_frame>
      <description>Postoperative Vasc quality of life score minus preoperative Vasc quality of life score</description>
    </secondary_outcome>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Peripheral Arterial Disease</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>GLASS staging</intervention_name>
      <description>use the Global Limb Anatomic Staging System (GLASS) to evaluate its correlation with clinical outcomes after revascularization</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with infrainguinal lesions suffering from critical limb-threatening ischemia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Clinical diagnosis of chronic limb-threatening ischemia (CLTI)&#xD;
  &#xD;
            2. Undergo endovascular therapy for infrainguinal lesions&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant women or female patients with potential childbearing&#xD;
  &#xD;
            2. Patients who have acute limb thromboembolism or require thrombectomy during the&#xD;
               procedure&#xD;
  &#xD;
            3. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or&#xD;
               occlusion)&#xD;
  &#xD;
            4. Patients with known allergy to contrast media&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Meng Ye, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ni Qihong, M.D.</last_name>
      <phone>+8615801900772</phone>
      <email>niqihong1989@163.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>global limb anatomic staging system</keyword>
    <keyword>infrainguinal Lesion</keyword>
    <keyword>critical limb-threatening ischemia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Arterial Disease</mesh_term>
      <mesh_term>Peripheral Vascular Diseases</mesh_term>
      <mesh_term>Ischemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05999669
  org study id: GLASS-EVT
  nct id: NCT05999669
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) proposes the Global
        Limb Anatomic Staging System (GLASS), a new angiographic scoring system to quantify the
        anatomic severity of infrainguinal disease in CLTI patients. However, GLASS validation still
        needs to be completed, and the infrapopliteal (IP) target artery pathway (TAP) was easily
        influenced by the procedures. Thus the IP target artery could be selected either as the least
        diseased artery based on angiography or prospectively based on the angiosome concept. So the
        investigators aim to evaluate its correlation with clinical outcomes after revascularization.
  The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) recommends using
        the Global Limb Anatomic Staging System (GLASS) to assess the severity of infrainguinal
        disease in CLTI patients. GLASS staging involves scoring the femoropopliteal (FP) and
        infrapopliteal (IP) segments separately. For IP segment scoring, the target artery path (TAP)
        is identified by the clinician based on either the least diseased or the recanalized IP path.
        However, this approach may lead to diverse GLASS staging results, especially for simple
        lesions below the knee. Additionally, the current version of GLASS does not account for
        multivessel IP revascularization, which may introduce subjective bias if a physician chooses
        different IP targets during multiple revascularization procedures.
  
        In order to improve our understanding of the current staging system, the investigators will
        establish a prospective registry that collects data on conservative patients who have Chronic
        Limb-Threatening Ischemia (CLTI) and undergo endovascular therapy for infrainguinal lesions.
        To evaluate the stage of the lesions, the investigators will use two distinct IP scoring
        techniques. One approach will be based on the least disease IP path as identified by the
        pre-interventional angiogram, while the second technique will be based on the recanalized IP
        path preferred by the clinician. This scoring will be carried out by experienced physicians
        and the results will be recorded in an electronic database. Then the correlation between the
        major adverse limb events (such as clinical-driven target limb revascularization, major
        amputation, and all-cause death) with the patient's Wound, Ischemia, foot Infection (WIFI)
        classification, GLASS anatomic staging, calcification severity, and modified Society for
        Vascular Surgery (SVS) run-off score will be analyzed.
  observational model: Cohort
  time perspective: Prospective
  measure: Rate of freedom from major adverse events (MAEs)
  time frame: 12-month
  description: Major adverse events (MAEs) is defined as index limb amputation above the ankle, clinical-driven target lesion revascularization (CD-TLR), or all-cause death
  measure: Rate of acute procedure success
  time frame: 72-hour after procedure
  description: Acute procedure success is defined as technique success ( the achievement of final residual diameter stenosis <30% for stent and <50% for angioplasty or atherectomy by angiography at the end of the procedure and without flow-limiting arterial dissection or hemodynamically significant trans-lesional pressure gradient <10 mm Hg for endovascular revascularization ) and freedom form MAEs within 72 hours of the index procedure.
  measure: Rate of freedom from clinical-driven target lesion revascularization (CD-TLR)
  time frame: 24-month
  description: Patients without clinical-driven target lesion revascularization (CD-TLR)
  measure: Rate of freedom from major adverse events (MAEs)
  time frame: 24-month
  description: Major adverse events (MAEs) is defined as index limb amputation above the ankle, clinical-driven target lesion revascularization (CD-TLR), or all-cause death
  measure: Primary sustained clinical improvement assessed by Rutherford classification
  time frame: 24-month
  description: Primary sustained clinical improvement is defined as an upward shift on the Rutherford classification to a level of claudication without the need for repeated target lesion revascularization in surviving patients without the need for unplanned amputation.
  measure: Change of quality of life assessed by Vasc quality of life scale
  time frame: 24-month
  description: Postoperative Vasc quality of life score minus preoperative Vasc quality of life score
  intervention type: Other
  intervention name: GLASS staging
  description: use the Global Limb Anatomic Staging System (GLASS) to evaluate its correlation with clinical outcomes after revascularization
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Meng Ye, M.D.
  role: Principal Investigator
  affiliation: Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
  last name: Ni Qihong, M.D.
  phone: +8615801900772
  email: niqihong1989@163.com
  responsible party type: Sponsor
  mesh term: Peripheral Arterial Disease
  mesh term: Peripheral Vascular Diseases
  mesh term: Ischemia
  sharing ipd: Undecided