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/NCT06016348</url>
    </required_header>
    <id_info>
      <org_study_id>115</org_study_id>
      <nct_id>NCT06016348</nct_id>
    </id_info>
    <brief_title>Predictors of Good Outcomes of Thrombectomy In Large Infarct Core Stroke</brief_title>
    <official_title>Predictors of Good Outcomes of Thrombectomy In Stroke Patients Within 24 Hours From Symptom Onset With Large Infarct Core</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>115 People's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Medicine and Pharmacy at Ho Chi Minh City</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>115 People's Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        Identify the factors associated with a favorable clinical outcome in participants with acute&#xD;
        ischemic stroke and large core infarcts within 24 hours of onset who are treated with&#xD;
        endovascular intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In 2022 and early 2023, three randomized controlled trials-RESCUE-JAPAN LIMIT, SELECT 2, and&#xD;
        ANGEL ASPECT-were published in the New England Journal of Medicine. These trials demonstrated&#xD;
        the effectiveness and safety of endovascular intervention using clot retrieval devices in&#xD;
        participants with acute ischemic stroke and large core infarcts. However, the rate of&#xD;
        participants achieving a good recovery remains low, while the mortality and disability rates&#xD;
        are very high.&#xD;
  &#xD;
        Moreover, in Vietnam, the acute stroke treatment process has not been optimized, and the&#xD;
        facilities and equipment for monitoring neurointensive care are not fully equipped. As a&#xD;
        result, endovascular intervention using clot retrieval devices in participants with large&#xD;
        core infarcts has not been widely implemented in the investigator's country, and the&#xD;
        effectiveness and safety of this treatment method have not been clearly evaluated.&#xD;
  &#xD;
        Addressing this issue is crucial for improving the quality of life and reducing the mortality&#xD;
        and disability rates caused by stroke in this participant group. This study aims to provide&#xD;
        new insights into the use of endovascular intervention for treating acute ischemic stroke&#xD;
        with a large core infarct volume, thereby supporting clinical decision-making and improving&#xD;
        treatment outcomes for participants with acute ischemic stroke and large core infarcts.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>90 Days</target_duration>
    <primary_outcome>
      <measure>The Modified Rankin Scale (mRS) of 0-3</measure>
      <time_frame>90 (± 14 days) after procedure</time_frame>
      <description>The rate of independent ambulation (mRS 0-3). The scale runs from 0-6, running from perfect health without symptoms to death.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>mRS of 0-2</measure>
      <time_frame>90 (± 14 days) after procedure</time_frame>
      <description>The rate of functional independence (mRS 0-2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mRS of 0-5</measure>
      <time_frame>90 (± 14 days) after procedure</time_frame>
      <description>The survival rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptomatic intracerebral hemorrhage (sICH)</measure>
      <time_frame>72 hours</time_frame>
      <description>sICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Early neurological deterioration</measure>
      <time_frame>72 hours</time_frame>
      <description>Clinical worsening that was higher by ≥4 points than the value at baseline during the first 72 h after ischaemic stroke.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Acute Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>Good outcome</arm_group_label>
      <description>mRS of 0-3; mRS of 0-2</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Unfavorable outcomes</arm_group_label>
      <description>mRS of 4-6</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endovascular treatment</intervention_name>
      <description>This procedure is instrumental in restoring cerebral blood flow by addressing the clot-induced obstruction within brain-supplying blood vessels.</description>
      <arm_group_label>Good outcome</arm_group_label>
      <arm_group_label>Unfavorable outcomes</arm_group_label>
      <other_name>Mechanical thrombectomy</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All adult patients underwent mechanical thrombectomy within 24 hours from symptom onset.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18-year-old&#xD;
  &#xD;
            -  Patients presenting with acute ischaemic stroke within 24 hours of stroke onset&#xD;
  &#xD;
            -  Received mechanical thrombectomy within 24 hours of stroke onset&#xD;
  &#xD;
            -  Imaging criteria include:&#xD;
  &#xD;
                 -  Large vessel occlusion on CT Angiography or MR Angiography (MRA) including tandem&#xD;
                    occlusion of the internal carotid artery and middle cerebral artery or internal&#xD;
                    carotid artery.&#xD;
  &#xD;
                 -  Core infarct criteria:&#xD;
  &#xD;
                      1. ASPECTS ≤5 on non-contrast CT or diffusion-weighted imaging (DWI).&#xD;
  &#xD;
                      2. ASPECTS score &gt;5 and core infarct volume of 50-150 ml on CT perfusion (CTP)&#xD;
                         or reduced cerebral blood flow (rCBF) &lt;30% on CTP or apparent diffusion&#xD;
                         coefficient (ADC) &lt;620 × 10-6 mm2/s on DWI.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients presenting with acute ischaemic stroke &gt;24 hours of stroke onset&#xD;
  &#xD;
            -  Intracranial hemorrhage identified by CT or MRI&#xD;
  &#xD;
            -  Pre-stroke modified Rankin Score (mRS) score of &gt;2 (indicating previous disability)&#xD;
  &#xD;
            -  Any terminal illness such that the patient has a life expectancy of less than 1 year.&#xD;
  &#xD;
            -  Patients with active cancer and undergoing treatment for cancer are excluded,&#xD;
  &#xD;
            -  Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Quoc-Trung Nguyen, M.D</last_name>
      <phone>+84938477516</phone>
      <email>quoctrungyds09@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Can Tho Central General Hospital</name>
        <address>
          <city>Cần Thơ</city>
          <country>Vietnam</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Loan Tran, MD</last_name>
        <phone>+84939108220</phone>
        <email>tranthloan7@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Lanh Nguyen, MD</last_name>
        <phone>+84982909254</phone>
        <email>lanh1995travinh@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Duc Ha, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Da Nang Stroke Center</name>
        <address>
          <city>Da Nang</city>
          <country>Vietnam</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Thien Le, MD</last_name>
        <phone>+84772434675</phone>
        <email>tbone93@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>115 PEOPLE's HOSPITAL</name>
        <address>
          <city>Ho Chi Minh City</city>
          <zip>70000</zip>
          <country>Vietnam</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Quoc-Trung Nguyen, MD</last_name>
        <phone>+84938477516</phone>
        <email>quoctrungyds09@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Huy-Thang Nguyen, PhD</last_name>
        <phone>+84909982115</phone>
        <email>nguyenhuythang115@gmail.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>University Medical Center</name>
        <address>
          <city>Ho Chi Minh City</city>
          <zip>70000</zip>
          <country>Vietnam</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Ba-Thang Nguyen, PhD</last_name>
        <phone>+84913888010</phone>
        <email>thangnb72@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Vinh-Khang Nguyen, MD</last_name>
        <phone>+84787415562</phone>
        <email>vinkhang23@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Vietnam</country>
    </location_countries>
    <reference>
      <citation>Yoshimura S, Sakai N, Yamagami H, Uchida K, Beppu M, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Takeuchi M, Yazawa Y, Kimura N, Shigeta K, Imamura H, Suzuki I, Enomoto Y, Tokunaga S, Morita K, Sakakibara F, Kinjo N, Saito T, Ishikura R, Inoue M, Morimoto T. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. 2022 Apr 7;386(14):1303-1313. doi: 10.1056/NEJMoa2118191. Epub 2022 Feb 9.</citation>
      <PMID>35138767</PMID>
    </reference>
    <reference>
      <citation>Sarraj A, Hassan AE, Abraham MG, Ortega-Gutierrez S, Kasner SE, Hussain MS, Chen M, Blackburn S, Sitton CW, Churilov L, Sundararajan S, Hu YC, Herial NA, Jabbour P, Gibson D, Wallace AN, Arenillas JF, Tsai JP, Budzik RF, Hicks WJ, Kozak O, Yan B, Cordato DJ, Manning NW, Parsons MW, Hanel RA, Aghaebrahim AN, Wu TY, Cardona-Portela P, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Gandhi CD, Kleinig TJ, Sahlein D, Elijovich L, Tekle W, Samaniego EA, Maali L, Abdulrazzak MA, Psychogios MN, Shuaib A, Pujara DK, Shaker F, Johns H, Sharma G, Yogendrakumar V, Ng FC, Rahbar MH, Cai C, Lavori P, Hamilton S, Nguyen T, Fifi JT, Davis S, Wechsler L, Pereira VM, Lansberg MG, Hill MD, Grotta JC, Ribo M, Campbell BC, Albers GW; SELECT2 Investigators. Trial of Endovascular Thrombectomy for Large Ischemic Strokes. N Engl J Med. 2023 Apr 6;388(14):1259-1271. doi: 10.1056/NEJMoa2214403. Epub 2023 Feb 10.</citation>
      <PMID>36762865</PMID>
    </reference>
    <results_reference>
      <citation>Huo X, Ma G, Tong X, Zhang X, Pan Y, Nguyen TN, Yuan G, Han H, Chen W, Wei M, Zhang J, Zhou Z, Yao X, Wang G, Song W, Cai X, Nan G, Li D, Wang AY, Ling W, Cai C, Wen C, Wang E, Zhang L, Jiang C, Liu Y, Liao G, Chen X, Li T, Liu S, Li J, Gao F, Ma N, Mo D, Song L, Sun X, Li X, Deng Y, Luo G, Lv M, He H, Liu A, Zhang J, Mu S, Liu L, Jing J, Nie X, Ding Z, Du W, Zhao X, Yang P, Liu L, Wang Y, Liebeskind DS, Pereira VM, Ren Z, Wang Y, Miao Z; ANGEL-ASPECT Investigators. Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct. N Engl J Med. 2023 Apr 6;388(14):1272-1283. doi: 10.1056/NEJMoa2213379. Epub 2023 Feb 10.</citation>
      <PMID>36762852</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>115 People's Hospital</investigator_affiliation>
      <investigator_full_name>Trung Nguyen</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>large core</keyword>
    <keyword>Low ASPECTS</keyword>
    <keyword>Endovascular treatment</keyword>
    <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>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>60 days</ipd_time_frame>
    </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/NCT06016348
  org study id: 115
  nct id: NCT06016348
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Identify the factors associated with a favorable clinical outcome in participants with acute
        ischemic stroke and large core infarcts within 24 hours of onset who are treated with
        endovascular intervention.
  In 2022 and early 2023, three randomized controlled trials-RESCUE-JAPAN LIMIT, SELECT 2, and
        ANGEL ASPECT-were published in the New England Journal of Medicine. These trials demonstrated
        the effectiveness and safety of endovascular intervention using clot retrieval devices in
        participants with acute ischemic stroke and large core infarcts. However, the rate of
        participants achieving a good recovery remains low, while the mortality and disability rates
        are very high.
  
        Moreover, in Vietnam, the acute stroke treatment process has not been optimized, and the
        facilities and equipment for monitoring neurointensive care are not fully equipped. As a
        result, endovascular intervention using clot retrieval devices in participants with large
        core infarcts has not been widely implemented in the investigator's country, and the
        effectiveness and safety of this treatment method have not been clearly evaluated.
  
        Addressing this issue is crucial for improving the quality of life and reducing the mortality
        and disability rates caused by stroke in this participant group. This study aims to provide
        new insights into the use of endovascular intervention for treating acute ischemic stroke
        with a large core infarct volume, thereby supporting clinical decision-making and improving
        treatment outcomes for participants with acute ischemic stroke and large core infarcts.
  observational model: Cohort
  time perspective: Prospective
  measure: The Modified Rankin Scale (mRS) of 0-3
  time frame: 90 (± 14 days) after procedure
  description: The rate of independent ambulation (mRS 0-3). The scale runs from 0-6, running from perfect health without symptoms to death.
  measure: mRS of 0-2
  time frame: 90 (± 14 days) after procedure
  description: The rate of functional independence (mRS 0-2)
  measure: mRS of 0-5
  time frame: 90 (± 14 days) after procedure
  description: The survival rate
  measure: Symptomatic intracerebral hemorrhage (sICH)
  time frame: 72 hours
  description: sICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death.
  measure: Early neurological deterioration
  time frame: 72 hours
  description: Clinical worsening that was higher by ≥4 points than the value at baseline during the first 72 h after ischaemic stroke.
  arm group label: Good outcome
  description: mRS of 0-3; mRS of 0-2
  arm group label: Unfavorable outcomes
  description: mRS of 4-6
  intervention type: Procedure
  intervention name: Endovascular treatment
  description: This procedure is instrumental in restoring cerebral blood flow by addressing the clot-induced obstruction within brain-supplying blood vessels.
  arm group label: Good outcome
  arm group label: Unfavorable outcomes
  other name: Mechanical thrombectomy
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Quoc-Trung Nguyen, M.D
  phone: +84938477516
  email: quoctrungyds09@gmail.com
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  country: Vietnam
  citation: Yoshimura S, Sakai N, Yamagami H, Uchida K, Beppu M, Toyoda K, Matsumaru Y, Matsumoto Y, Kimura K, Takeuchi M, Yazawa Y, Kimura N, Shigeta K, Imamura H, Suzuki I, Enomoto Y, Tokunaga S, Morita K, Sakakibara F, Kinjo N, Saito T, Ishikura R, Inoue M, Morimoto T. Endovascular Therapy for Acute Stroke with a Large Ischemic Region. N Engl J Med. 2022 Apr 7;386(14):1303-1313. doi: 10.1056/NEJMoa2118191. Epub 2022 Feb 9.
  PMID: 35138767
  citation: Sarraj A, Hassan AE, Abraham MG, Ortega-Gutierrez S, Kasner SE, Hussain MS, Chen M, Blackburn S, Sitton CW, Churilov L, Sundararajan S, Hu YC, Herial NA, Jabbour P, Gibson D, Wallace AN, Arenillas JF, Tsai JP, Budzik RF, Hicks WJ, Kozak O, Yan B, Cordato DJ, Manning NW, Parsons MW, Hanel RA, Aghaebrahim AN, Wu TY, Cardona-Portela P, Perez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Gandhi CD, Kleinig TJ, Sahlein D, Elijovich L, Tekle W, Samaniego EA, Maali L, Abdulrazzak MA, Psychogios MN, Shuaib A, Pujara DK, Shaker F, Johns H, Sharma G, Yogendrakumar V, Ng FC, Rahbar MH, Cai C, Lavori P, Hamilton S, Nguyen T, Fifi JT, Davis S, Wechsler L, Pereira VM, Lansberg MG, Hill MD, Grotta JC, Ribo M, Campbell BC, Albers GW; SELECT2 Investigators. Trial of Endovascular Thrombectomy for Large Ischemic Strokes. N Engl J Med. 2023 Apr 6;388(14):1259-1271. doi: 10.1056/NEJMoa2214403. Epub 2023 Feb 10.
  PMID: 36762865
  citation: Huo X, Ma G, Tong X, Zhang X, Pan Y, Nguyen TN, Yuan G, Han H, Chen W, Wei M, Zhang J, Zhou Z, Yao X, Wang G, Song W, Cai X, Nan G, Li D, Wang AY, Ling W, Cai C, Wen C, Wang E, Zhang L, Jiang C, Liu Y, Liao G, Chen X, Li T, Liu S, Li J, Gao F, Ma N, Mo D, Song L, Sun X, Li X, Deng Y, Luo G, Lv M, He H, Liu A, Zhang J, Mu S, Liu L, Jing J, Nie X, Ding Z, Du W, Zhao X, Yang P, Liu L, Wang Y, Liebeskind DS, Pereira VM, Ren Z, Wang Y, Miao Z; ANGEL-ASPECT Investigators. Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct. N Engl J Med. 2023 Apr 6;388(14):1272-1283. doi: 10.1056/NEJMoa2213379. Epub 2023 Feb 10.
  PMID: 36762852
  responsible party type: Principal Investigator
  investigator affiliation: 115 People's Hospital
  investigator full name: Trung Nguyen
  investigator title: Principal Investigator
  mesh term: Stroke
  mesh term: Ischemic Stroke
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: 60 days