<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/NCT03234634</url>
  </required_header>
  <id_info>
    <org_study_id>4-2017-0511</org_study_id>
    <nct_id>NCT03234634</nct_id>
  </id_info>
  <brief_title>Collateral-based reSetting of Endovascular Treatment Time Window for Stroke (CoSETS)</brief_title>
  <official_title>Collateral-based reSetting of Endovascular Treatment Time Window for Stroke (CoSETS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      This study is a prospective, partly randomized, multi-center, Phase III, controlled trial,&#xD;
      designed to show that the onset-to-puncture time (OPT) for good functional outcome (defined&#xD;
      by modified Rankin Scale score at 3 months, 0-2) can be set depending on collateral status&#xD;
      based on multiphase CT angiogram. The purpose of this study is to prove that (1) for patients&#xD;
      with poor collaterals, there will no difference in good outcome rate between endovascular&#xD;
      treatment and best medical treatment group if onset-to-puncture time is between 150 minutes&#xD;
      and 600 minutes, and 2) for patients wih good collaterals, the rate of good outcome is equal&#xD;
      to or greater than 42% (10% greater than historical control) if onset-to-puncture time is&#xD;
      between 150 minutes and 600 minutes. Patients will initially be classified into 3 arms based&#xD;
      on both collateral status on multiphase CT angiography and whether or not receiving&#xD;
      endovascular thrombectomy: group 1, patients with good collaterals and receiving endovascular&#xD;
      thrombectomy, 2) group 2a, patient with poor collaterals and receiving endovascular&#xD;
      thrombectomy, and 3) group 2b, patients with poor collaterals and not receiving endovascular&#xD;
      thrombectomy. Patients with good collaterals will receive endovascular thrombectomy (EVT) if&#xD;
      onset-to-puncture time is between 150 minutes and 600 minutes after last seen well time. Of&#xD;
      the patients with poor collaterals, they will be randomized into endovascular treatment and&#xD;
      best medical treatment group, if onset-to-puncture time is between 150 minutes and 600&#xD;
      minutes, (onset-to-puncture time is not possible within 150 minutes but possible within 600&#xD;
      minutes after last seen well). Primary endpoint is the rate of good outcome at 3 months. The&#xD;
      number of subjects needed with statistical power of 0.8 and alpha value of 0.025 is estimated&#xD;
      309 patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    As the guideline for the acute stroke endovascular treatment of the AHA/ASA was changed, DSMB&#xD;
    recommended an end to the study.&#xD;
  </why_stopped>
  <start_date type="Actual">August 13, 2018</start_date>
  <completion_date type="Actual">May 20, 2019</completion_date>
  <primary_completion_date type="Actual">May 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Patients will be dichotomized into good collateral (group 1) and poor collateral group (group 2) according to collateral status assessed on multiphase CT angiography.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The rate of good functional outcome defined by modified Rankin Scale score 0 - 2</measure>
    <time_frame>90 days ± 14 days after enrollment</time_frame>
    <description>The scale runs from 0-6, running from perfect health without symptoms to death 0 - No symptoms.&#xD;
- No significant disability. Able to carry out all usual activities, despite some symptoms.&#xD;
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.&#xD;
- Moderate disability. Requires some help, but able to walk unassisted.&#xD;
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.&#xD;
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.&#xD;
- Dead.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>modified Rankin Scale score</measure>
    <time_frame>90 days ± 14 days after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIHSS score</measure>
    <time_frame>24 hours after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIHSS score</measure>
    <time_frame>72 hours after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIHSS score</measure>
    <time_frame>7 days after enrollment</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">291</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Group 1: patients with good collateral</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2a, patient with poor collaterals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 patients (poor collateral group) will be randomized into endovascular thrombectomy group (2a) and best medical treatment group (2b), if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2b, patients with poor collaterals</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group 2 patients (poor collateral group) will be randomized into endovascular thrombectomy group (2a) and best medical treatment group (2b), if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endovascular thrombectomy</intervention_name>
    <description>Intervention description : Group 1: patients with good collateral, Group 2: patient with poor collateral&#xD;
Group 1 patients (good collateral group) will receive endovascular thrombectomy using stent retriever, aspiration catheter, or both, if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.&#xD;
Group 2 patients (poor collateral group) will be randomized into endovascular thrombectomy group (2a) and best medical treatment group (2b), if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.</description>
    <arm_group_label>Group 2a, patient with poor collaterals</arm_group_label>
    <other_name>best medical treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute ischemic stroke&#xD;
&#xD;
          -  Age ≥ 19 years old&#xD;
&#xD;
          -  Modified Rankin Scale score before qualifying stroke, 0 or 1&#xD;
&#xD;
          -  Baseline National Institute of Health Stroke Scale, 5 or greater&#xD;
&#xD;
          -  Baseline Alberta Stroke Program Early Computed Tomographic Sign, 6 or greater&#xD;
&#xD;
          -  Documented occlusion of relevant intracranial internal carotid artery or middle&#xD;
             cerebral artery M1 segment on multiphase CT angiogram&#xD;
&#xD;
          -  Starting of endovascular treatment (femoral artery puncture) should be possible&#xD;
             between 150 minutes and 600 minutes after last seen well time.&#xD;
&#xD;
          -  Nonenhanced CT and multiphase CT angiogram should be obtained in the participating&#xD;
             hospital&#xD;
&#xD;
          -  If indicated, intravenous administration of tissue plasminogen activator should be&#xD;
             given.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Femoral puncture is impossible&#xD;
&#xD;
          -  Pregnancy or positive on serum beta-hCG test&#xD;
&#xD;
          -  Known uncontrollable allergic reaction to iodized contrast media&#xD;
&#xD;
          -  Intracranial cerebral artery dissection&#xD;
&#xD;
          -  Suspected chronic occlusion of the relevant intracranial large artery&#xD;
&#xD;
          -  In hospital stroke&#xD;
&#xD;
          -  Bilateral internal carotid artery or middle cerebral artery occlusion&#xD;
&#xD;
          -  Underlying severe medical or surgical disease which may affect treatment response.&#xD;
&#xD;
          -  Clinical follow is impossible because of social or medical problems.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yonsei University Healthcare System, Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Yeonsei-ro Seodaemun-gu</state>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>June 19, 2019</last_update_submitted>
  <last_update_submitted_qc>June 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03234634
org study id: 4-2017-0511
nct id: NCT03234634
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, partly randomized, multi-center, Phase III, controlled trial,
      designed to show that the onset-to-puncture time (OPT) for good functional outcome (defined
      by modified Rankin Scale score at 3 months, 0-2) can be set depending on collateral status
      based on multiphase CT angiogram. The purpose of this study is to prove that (1) for patients
      with poor collaterals, there will no difference in good outcome rate between endovascular
      treatment and best medical treatment group if onset-to-puncture time is between 150 minutes
      and 600 minutes, and 2) for patients wih good collaterals, the rate of good outcome is equal
      to or greater than 42% (10% greater than historical control) if onset-to-puncture time is
      between 150 minutes and 600 minutes. Patients will initially be classified into 3 arms based
      on both collateral status on multiphase CT angiography and whether or not receiving
      endovascular thrombectomy: group 1, patients with good collaterals and receiving endovascular
      thrombectomy, 2) group 2a, patient with poor collaterals and receiving endovascular
      thrombectomy, and 3) group 2b, patients with poor collaterals and not receiving endovascular
      thrombectomy. Patients with good collaterals will receive endovascular thrombectomy (EVT) if
      onset-to-puncture time is between 150 minutes and 600 minutes after last seen well time. Of
      the patients with poor collaterals, they will be randomized into endovascular treatment and
      best medical treatment group, if onset-to-puncture time is between 150 minutes and 600
      minutes, (onset-to-puncture time is not possible within 150 minutes but possible within 600
      minutes after last seen well). Primary endpoint is the rate of good outcome at 3 months. The
      number of subjects needed with statistical power of 0.8 and alpha value of 0.025 is estimated
      309 patients.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Patients will be dichotomized into good collateral (group 1) and poor collateral group (group 2) according to collateral status assessed on multiphase CT angiography.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The rate of good functional outcome defined by modified Rankin Scale score 0 - 2
time frame: 90 days ± 14 days after enrollment
description: The scale runs from 0-6, running from perfect health without symptoms to death 0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead.
measure: modified Rankin Scale score
time frame: 90 days ± 14 days after enrollment
measure: NIHSS score
time frame: 24 hours after enrollment
measure: NIHSS score
time frame: 72 hours after enrollment
measure: NIHSS score
time frame: 7 days after enrollment
arm group label: Group 1: patients with good collateral
arm group type: No Intervention
arm group label: Group 2a, patient with poor collaterals
arm group type: Experimental
description: Group 2 patients (poor collateral group) will be randomized into endovascular thrombectomy group (2a) and best medical treatment group (2b), if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.
arm group label: Group 2b, patients with poor collaterals
arm group type: No Intervention
description: Group 2 patients (poor collateral group) will be randomized into endovascular thrombectomy group (2a) and best medical treatment group (2b), if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.
intervention type: Procedure
intervention name: endovascular thrombectomy
description: Intervention description : Group 1: patients with good collateral, Group 2: patient with poor collateral
Group 1 patients (good collateral group) will receive endovascular thrombectomy using stent retriever, aspiration catheter, or both, if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.
Group 2 patients (poor collateral group) will be randomized into endovascular thrombectomy group (2a) and best medical treatment group (2b), if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.
arm group label: Group 2a, patient with poor collaterals
other name: best medical treatment
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
sharing ipd: No