<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/NCT03290885</url>
  </required_header>
  <id_info>
    <org_study_id>2017014F</org_study_id>
    <secondary_id>2016-A01735-46</secondary_id>
    <nct_id>NCT03290885</nct_id>
  </id_info>
  <brief_title>Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction</brief_title>
  <acronym>ASTER2</acronym>
  <official_title>Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction: the Randomized ASTER2 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</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>
      Mechanical thrombectomy (MT) with a stent retriever (SR) device is now the standard&#xD;
      intervention in ischemic stroke with large vessel occlusion. Favorable outcome is strongly&#xD;
      associated with the successful reperfusion status. New device of MT such as contact&#xD;
      aspiration seems promising to increase reperfusion status and clinical outcome.&#xD;
&#xD;
      The main hypothesis is to show the superiority of combining the use of contact aspiration&#xD;
      with a stent retriever compared to a stent retriever alone in treatment of acute stroke due&#xD;
      to proximal arterial occlusion.&#xD;
&#xD;
      The primary endpoint is the rate of perfect reperfusion score at the end of the endovascular&#xD;
      procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perfect reperfusion rate</measure>
    <time_frame>24 hours</time_frame>
    <description>Perfect reperfusion rate at the end of angiography defined as a Thrombolysis In Cerebral Infarction (TICI) 2c/3 score (TICI score = Thrombolysis In Cerebral Infarction)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of successful reperfusion</measure>
    <time_frame>24 hours</time_frame>
    <description>Rate of successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) at end of endovascular procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from groin puncture to achieve TICI 2c or better revascularization</measure>
    <time_frame>24 hours</time_frame>
    <description>Time from groin puncture to achieve TICI 2c or better revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time between groin puncture to clot contact and clot contact to maximum reperfusion</measure>
    <time_frame>24 hours</time_frame>
    <description>Time between groin puncture to clot contact and clot contact to maximum reperfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin scale (mRs)</measure>
    <time_frame>90 days</time_frame>
    <description>Global disability assessed by overall distribution of mRs at 90-days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of favorable functional independence</measure>
    <time_frame>90 days</time_frame>
    <description>Rate of favorable functional independence defined as a mRS 0-2 at 90 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of excellent functional outcome</measure>
    <time_frame>90 days</time_frame>
    <description>Rate of excellent functional outcome defined as a Modified Rankin scale (mRS) 0-1 at 90 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIHSS score</measure>
    <time_frame>24 hours</time_frame>
    <description>Change in NIHSS from baseline to 24 hours (delta NIHSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of symptomatic and asymptomatic intracerebral hemorrhage</measure>
    <time_frame>24 hours</time_frame>
    <description>Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI 24h after thrombectomy (according the third European Cooperative Acute Stroke Study (ECASS3) classification) (independent core lab adjudication).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of parenchymal hematoma</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of all-cause mortality</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of periprocedural complications</measure>
    <time_frame>90 days</time_frame>
    <description>- Rate of periprocedural complications: Occurrence of emboli to new territory (ENT), vasospasm, dissection, or perforation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average cost per patient</measure>
    <time_frame>90 days</time_frame>
    <description>Average cost per patient with complete recanalization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">408</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Combined use of contact aspiration and stent retriever</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combined use of contact aspiration and stent retriever mechanical thrombectomy for recanalization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stent retriever mechanical thrombectomy alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stent retriever mechanical thrombectomy alone for recanalisation</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Combined contact aspiration/Stent Retriever Technique</intervention_name>
    <description>Combined contact aspiration/SR is performed using a balloon-guide catheter (BGC). A 0.021 to 0.027 inch inner lumen microcatheter with a 0.014 to 0.016 inch micro-wire inside is introduced into a large-bore aspiration catheter and this construct is introduced into BGC. The BGC is placed into the origin of the cervical internal carotid artery (ICA). The catheter is advanced past the thrombus over the micro-wire to allow the SR deployment. The SR is deployed across the occlusion. Then the large bore distal access catheter is advanced to contact the proximal edge of the SR. The aspiration pump is connected to the large bore distal access catheter. After at least 90 sec, the SR and the large bore distal access catheter are pulled out as an unit from the BGC and the patient. Manual aspiration is also be applied to the BGC during the pull-out manoeuver which is performed after the temporary inflation of the balloon at the tip of the BGC to ensure flow arrest into the carotid</description>
    <arm_group_label>Combined use of contact aspiration and stent retriever</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stent retriever technique</intervention_name>
    <description>The technique used should be in accordance with the device instruction for use. A large bore balloon guide catheter has to be placed into the cervical ICA.&#xD;
A suitable delivery microcatheter is navigated over a micro-wire into the occluded major coronary artery MCA and across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent retriever device is then deployed across the occlusion.&#xD;
After at least 90 seconds, removal should occur with proximal occlusion by inflation of the balloon guide catheter.</description>
    <arm_group_label>Stent retriever mechanical thrombectomy alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and older (i.e., candidates must have had their 18th birthday)&#xD;
&#xD;
          -  Groin puncture carried out within 8 hours of first symptoms&#xD;
&#xD;
          -  Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA&#xD;
             bifurcation, M1 or M2)&#xD;
&#xD;
          -  Consenting requirements met according to French laws.&#xD;
&#xD;
          -  With or without intravenous thrombolysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of large vessel occlusion on non-invasive imaging&#xD;
&#xD;
          -  Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic&#xD;
             territory&#xD;
&#xD;
          -  Suspected pregnancy; if, a woman is of childbearing potential, a urine or serum beta&#xD;
             human chorionic gonadotropin (betaHCG) test is positive.&#xD;
&#xD;
          -  Severe contrast medium allergy or absolute contraindication to iodinated agents.&#xD;
&#xD;
          -  Patient has severe or fatal comorbidities that will likely prevent improvement or&#xD;
             follow-up or that will render the procedure unlikely to benefit the patient.&#xD;
&#xD;
          -  Acute ischemic stroke involving posterior circulation (vertebrobasilar occlusion)&#xD;
&#xD;
          -  Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis&#xD;
             requiring treatment.&#xD;
&#xD;
          -  Patients benefiting from a legal protection&#xD;
&#xD;
          -  Non-membership of a national insurance scheme&#xD;
&#xD;
          -  Opposition of the patient or (in case of inclusion as a matter of urgency) of the&#xD;
             trustworthy person&#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>Bertrand Lapergue, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Foch</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michel Piotin, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Fondation Ophtalmologique de Rothschild</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Limoges</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nancy</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondation Ophtalmologique Rotschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kremlin-Bicêtre (APHP)</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Pitié-Salpétrière (APHP)</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lariboisière (APHP)</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</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>Ischemic Stroke</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT03290885
org study id: 2017014F
secondary id: 2016-A01735-46
nct id: NCT03290885
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mechanical thrombectomy (MT) with a stent retriever (SR) device is now the standard
      intervention in ischemic stroke with large vessel occlusion. Favorable outcome is strongly
      associated with the successful reperfusion status. New device of MT such as contact
      aspiration seems promising to increase reperfusion status and clinical outcome.

      The main hypothesis is to show the superiority of combining the use of contact aspiration
      with a stent retriever compared to a stent retriever alone in treatment of acute stroke due
      to proximal arterial occlusion.

      The primary endpoint is the rate of perfect reperfusion score at the end of the endovascular
      procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Perfect reperfusion rate
time frame: 24 hours
description: Perfect reperfusion rate at the end of angiography defined as a Thrombolysis In Cerebral Infarction (TICI) 2c/3 score (TICI score = Thrombolysis In Cerebral Infarction)
measure: Rate of successful reperfusion
time frame: 24 hours
description: Rate of successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) at end of endovascular procedure
measure: Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy
time frame: 24 hours
measure: Time from groin puncture to achieve TICI 2c or better revascularization
time frame: 24 hours
description: Time from groin puncture to achieve TICI 2c or better revascularization
measure: Time between groin puncture to clot contact and clot contact to maximum reperfusion
time frame: 24 hours
description: Time between groin puncture to clot contact and clot contact to maximum reperfusion
measure: Modified Rankin scale (mRs)
time frame: 90 days
description: Global disability assessed by overall distribution of mRs at 90-days
measure: Rate of favorable functional independence
time frame: 90 days
description: Rate of favorable functional independence defined as a mRS 0-2 at 90 days
measure: Rate of excellent functional outcome
time frame: 90 days
description: Rate of excellent functional outcome defined as a Modified Rankin scale (mRS) 0-1 at 90 days
measure: NIHSS score
time frame: 24 hours
description: Change in NIHSS from baseline to 24 hours (delta NIHSS)
measure: Rate of symptomatic and asymptomatic intracerebral hemorrhage
time frame: 24 hours
description: Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI 24h after thrombectomy (according the third European Cooperative Acute Stroke Study (ECASS3) classification) (independent core lab adjudication).
measure: Rate of parenchymal hematoma
time frame: 90 days
measure: Rate of all-cause mortality
time frame: 90 days
measure: Rate of periprocedural complications
time frame: 90 days
description: - Rate of periprocedural complications: Occurrence of emboli to new territory (ENT), vasospasm, dissection, or perforation.
measure: Average cost per patient
time frame: 90 days
description: Average cost per patient with complete recanalization
arm group label: Combined use of contact aspiration and stent retriever
arm group type: Experimental
description: Combined use of contact aspiration and stent retriever mechanical thrombectomy for recanalization
arm group label: Stent retriever mechanical thrombectomy alone
arm group type: Active Comparator
description: Stent retriever mechanical thrombectomy alone for recanalisation
intervention type: Combination Product
intervention name: Combined contact aspiration/Stent Retriever Technique
description: Combined contact aspiration/SR is performed using a balloon-guide catheter (BGC). A 0.021 to 0.027 inch inner lumen microcatheter with a 0.014 to 0.016 inch micro-wire inside is introduced into a large-bore aspiration catheter and this construct is introduced into BGC. The BGC is placed into the origin of the cervical internal carotid artery (ICA). The catheter is advanced past the thrombus over the micro-wire to allow the SR deployment. The SR is deployed across the occlusion. Then the large bore distal access catheter is advanced to contact the proximal edge of the SR. The aspiration pump is connected to the large bore distal access catheter. After at least 90 sec, the SR and the large bore distal access catheter are pulled out as an unit from the BGC and the patient. Manual aspiration is also be applied to the BGC during the pull-out manoeuver which is performed after the temporary inflation of the balloon at the tip of the BGC to ensure flow arrest into the carotid
arm group label: Combined use of contact aspiration and stent retriever
intervention type: Device
intervention name: Stent retriever technique
description: The technique used should be in accordance with the device instruction for use. A large bore balloon guide catheter has to be placed into the cervical ICA.
A suitable delivery microcatheter is navigated over a micro-wire into the occluded major coronary artery MCA and across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent retriever device is then deployed across the occlusion.
After at least 90 seconds, removal should occur with proximal occlusion by inflation of the balloon guide catheter.
arm group label: Stent retriever mechanical thrombectomy alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bertrand Lapergue, MD
role: Principal Investigator
affiliation: Hôpital Foch
last name: Michel Piotin, MD
role: Study Chair
affiliation: Fondation Ophtalmologique de Rothschild
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Infarction