<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/NCT03804060</url>
  </required_header>
  <id_info>
    <org_study_id>EDC-3599</org_study_id>
    <nct_id>NCT03804060</nct_id>
  </id_info>
  <brief_title>REperfusion With Cooling in CerebraL Acute IscheMia II</brief_title>
  <acronym>RECCLAIM-II</acronym>
  <official_title>A Multicenter, Prospective, Randomized-controlled Trial to Assess the Safety and Feasibility of Cooling as an Adjunctive Therapy to Thrombectomy and Reperfusion in Patients With Acute Cerebral Ischemia and Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ZOLL Circulation, Inc., USA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ZOLL Circulation, Inc., USA</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine the feasibility and safety of achieving&#xD;
      rapid hypothermia with the Proteus Intravascular Temperature Management (IVTM) system for&#xD;
      patients experiencing acute ischemic stroke due to a large vessel occlusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 23, 2019</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Test Arm patients achieving target temperature</measure>
    <time_frame>1 hour after thrombectomy</time_frame>
    <description>Percentage of Test Arm patients achieving target temperature &lt; 34 ºC within 1 hour of arterial puncture for thrombectomy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean door-to-Recanalization time</measure>
    <time_frame>perioperative</time_frame>
    <description>door-to-Recanalization time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of hemorrhagic conversion in each arm within 36 hours of Recanalization</measure>
    <time_frame>36 hours</time_frame>
    <description>Rate of hemorrhagic conversion</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Cooling + Recanalization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Thermogard XP3 IVTM System before and after recanalization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recanalization only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow recanalization only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thermogard XP3</intervention_name>
    <description>Cooling with the ZOLL® Circulation catheter and the ZOLL® Intravascular Temperature Management system to initiate and maintain hypothermia for 6 hours as an adjunct to endovascular Recanalization.</description>
    <arm_group_label>Cooling + Recanalization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Recanalization only</intervention_name>
    <description>Standard of Care for recanalization</description>
    <arm_group_label>Recanalization only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        All Inclusion Criteria must be answered YES for Patient to be eligible.&#xD;
&#xD;
          1. Age ≥18 and ≤85;&#xD;
&#xD;
          2. Signs and symptoms consistent with an acute ischemic stroke with anterior circulation&#xD;
             large vessel occlusion (M1 MCA, carotid-terminus occlusion, Tandem occlusion allowed&#xD;
             (Extracranial ICA+carotid T or M1 MCA)) as determined by CT imaging; (i.e., hyperdense&#xD;
             sign on non-contrast CT or CT angiogram);&#xD;
&#xD;
          3. Ability to perform arterial puncture within 24 hours from symptom onset or LKN;&#xD;
&#xD;
          4. ASPECTS score of 6-10 on non-contrast CT of the brain if under 80 years; ASPECTS 9-10&#xD;
             if age 80-85;&#xD;
&#xD;
          5. For transfer patients with anticipated arterial puncture greater than 6 hours from&#xD;
             symptom onset or LKN, qualifying imaging must be performed within 2 hours prior to&#xD;
             enrolling hospital arrival; or with a newly obtained non-contrast CT scan if this time&#xD;
             is exceeded&#xD;
&#xD;
          6. Candidate for endovascular thrombectomy therapy in accordance with best practices per&#xD;
             AHA standard stroke guidelines meeting all labeling requirements for EVT in the trial;&#xD;
&#xD;
          7. No contraindications to general anesthesia, conscious sedation or allergies to any&#xD;
             components associated with the anticipated diagnostic or treatment procedures that&#xD;
             cannot be treated;&#xD;
&#xD;
          8. A pre-stroke modified Rankin Score (mRS) of 0 or 1 (Appendix 4);&#xD;
&#xD;
          9. Baseline CT scan shows no hemorrhage;&#xD;
&#xD;
         10. NIHSS greater than or equal to 8 (Appendix 3);&#xD;
&#xD;
         11. Patient is capable of complying with study procedures and agrees to complete all&#xD;
             required study procedures, study visits and associated activities;&#xD;
&#xD;
         12. Legally authorized representative must be able to understand and give written informed&#xD;
             consent. Patient will assent if capable. Patient may be re-consented once it is&#xD;
             established that there is no memory loss or cognitive impairment.&#xD;
&#xD;
        5.2 Exclusion Criteria In order to be eligible for participation, patients must meet all&#xD;
        Inclusion and Exclusion Criteria.&#xD;
&#xD;
        Inclusion Criteria All Inclusion Criteria must be answered YES for Patient to be eligible.&#xD;
&#xD;
          1. Age ≥18 and ≤85;&#xD;
&#xD;
          2. Signs and symptoms consistent with an acute ischemic stroke with anterior circulation&#xD;
             large vessel occlusion (M1 MCA, carotid-terminus occlusion, Tandem occlusion allowed&#xD;
             (Extracranial ICA+carotid T or M1 MCA)) as determined by CT imaging; (i.e., hyper&#xD;
             dense sign on non-contrast CT or CT angiogram);&#xD;
&#xD;
          3. Ability to perform arterial puncture within 24 hours from symptom onset or LKN;&#xD;
&#xD;
          4. ASPECT score of 6-10 on non-contrast CT of the brain if under 80 years; ASPECTS 9-10&#xD;
             if age 80-85;&#xD;
&#xD;
          5. For transfer patients with anticipated arterial puncture greater than 6 hours from&#xD;
             symptom onset or LKN, qualifying imaging must be performed within 2 hours prior to&#xD;
             enrolling hospital arrival or with a newly obtained non-contrast CT scan if this time&#xD;
             is exceeded;&#xD;
&#xD;
          6. Candidate for endovascular thrombectomy therapy in accordance with best practices per&#xD;
             AHA standard stroke guidelines meeting all labeling requirements for EVT in the trial;&#xD;
&#xD;
          7. No contraindications to general anesthesia, conscious sedation or allergies to any&#xD;
             components associated with the anticipated diagnostic or treatment procedures that&#xD;
             cannot be treated;&#xD;
&#xD;
          8. A pre-stroke mRS of 0 or 1 (Appendix 4);&#xD;
&#xD;
          9. Baseline CT scan shows no hemorrhage;&#xD;
&#xD;
         10. NIHSS greater than or equal to 8 (Appendix 3);&#xD;
&#xD;
         11. Patient is capable of complying with study procedures and agrees to complete all&#xD;
             required study procedures, study visits and associated activities;&#xD;
&#xD;
         12. Legally authorized representative must be able to understand and give written informed&#xD;
             consent. Patient will assent if capable. Patient may be re-consented once it is&#xD;
             established that there is no memory loss or cognitive impairment.&#xD;
&#xD;
        Exclusion Criteria All Exclusion Criteria must be answered NO to be eligible.&#xD;
&#xD;
          1. Patient arrives to the enrolling hospital intubated&#xD;
&#xD;
          2. Female patients of childbearing potential who are known to be or may be pregnant;&#xD;
&#xD;
          3. The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia,&#xD;
             sickle cell anemia, will refuse blood transfusions or contraindication to heparin;&#xD;
             history of genetically confirmed hypercoagulable syndrome&#xD;
&#xD;
          4. The patient has a height of &lt; 1.5 meters (4 feet 11 inches);&#xD;
&#xD;
          5. Use of warfarin with INR &gt; 1.7;&#xD;
&#xD;
          6. Blood clinical chemistry potassium (K+) &lt; 2.7;&#xD;
&#xD;
          7. History of severe dementia and currently taking medication for cognitive impairment or&#xD;
             behavior disorder;&#xD;
&#xD;
          8. End stage renal disease on hemodialysis;&#xD;
&#xD;
          9. Known presence of an IVC filter;&#xD;
&#xD;
         10. Contrast dye allergy with history of anaphylaxis, known serious sensitivity to&#xD;
             contrast agents or any condition in which angiography is contraindicated;&#xD;
&#xD;
         11. Known to have contraindications to radiological imaging;&#xD;
&#xD;
         12. Known allergy to meperidine or buspar or dexmedetomidine;&#xD;
&#xD;
         13. Sustained hypertension (SBP &gt; 185 or DBP &gt; 110 unable to be treated with a continuous&#xD;
             infusion, e.g., nicardipine);&#xD;
&#xD;
         14. Baseline CT/MR showing evidence of arterial vasculitis or dissection;&#xD;
&#xD;
         15. Baseline CT/MR evidence of multiple vascular territory acute stroke;&#xD;
&#xD;
         16. Excessive tortuosity of cervical vessels;&#xD;
&#xD;
         17. Intracranial stent in area that may impact Recanalization;&#xD;
&#xD;
         18. Presence of Pulmonary embolism, ilio-femoral or deep vein thrombosis&#xD;
&#xD;
         19. Presence of clinical signs of sepsis&#xD;
&#xD;
         20. Ongoing or spontaneous atrial fibrillation indicating severe peripheral vascular&#xD;
             disease, aortic disease, or proximal cerebrovascular disease that in the opinion of&#xD;
             the investigator precludes access or safe endovascular treatment&#xD;
&#xD;
         21. Presence of any other serious comorbidity that would be likely to impact life&#xD;
             expectancy to less than 6 months or limit Patient cooperation or study compliance&#xD;
&#xD;
         22. Concurrent participation in an investigational clinical study (excluding registries)&#xD;
             that has not completed the follow-up period or planned participation in another study&#xD;
             within the next 3 months;&#xD;
&#xD;
         23. Patient has any other condition(s) or circumstance(s) that, in the judgement of the&#xD;
             investigator, might interfere with or impact the collection of high quality data, or&#xD;
             with the completion of follow up requirements within the study windows.&#xD;
&#xD;
         24. Patient has active or symptomatic COVID-19&#xD;
&#xD;
         25. Patients without a legally authorized representative to sign the consent form will be&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rishi Gupta, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wellstar Medical Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shweta Kalpa, MD</last_name>
    <phone>408-419-2357</phone>
    <email>skalpa@zoll.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Honor Health</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>WellStar Kennestone Regional Medical Center</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rishi Gupta, MD</last_name>
    </contact>
    <investigator>
      <last_name>Rishi Gupta, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Queen's Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kim T Nguyen, RN</last_name>
      <email>knguyen@queens.org</email>
    </contact>
    <investigator>
      <last_name>Chung-Huan J Sun, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elida Romo</last_name>
    </contact>
    <investigator>
      <last_name>Tareq Kass-Hout, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Henry Ford</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alex Chebl, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Miami Valley Hospital - Premier Health</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45409</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>ProMedica Toledo Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Mercy Health</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sam Zaidat, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Therapeutic Hypothermia</keyword>
  <keyword>Cooling</keyword>
  <keyword>Stroke</keyword>
  <keyword>Neurological Acute Care</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>
    <mesh_term>Ischemia</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/NCT03804060
org study id: EDC-3599
nct id: NCT03804060
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The primary objective of this study is to determine the feasibility and safety of achieving
      rapid hypothermia with the Proteus Intravascular Temperature Management (IVTM) system for
      patients experiencing acute ischemic stroke due to a large vessel occlusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Test Arm patients achieving target temperature
time frame: 1 hour after thrombectomy
description: Percentage of Test Arm patients achieving target temperature < 34 ºC within 1 hour of arterial puncture for thrombectomy
measure: Mean door-to-Recanalization time
time frame: perioperative
description: door-to-Recanalization time
measure: Rate of hemorrhagic conversion in each arm within 36 hours of Recanalization
time frame: 36 hours
description: Rate of hemorrhagic conversion
arm group label: Cooling + Recanalization
arm group type: Experimental
description: The subjects will be considered to be enrolled in the Test Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Test Arm of the trial to allow cooling with the Thermogard XP3 IVTM System before and after recanalization.
arm group label: Recanalization only
arm group type: Active Comparator
description: The subjects will be considered to be enrolled in the Control Arm of the trial when all inclusion and exclusion criteria have been met, the informed consent form has been signed, and randomization to the Control Arm of the trial to allow recanalization only.
intervention type: Device
intervention name: Thermogard XP3
description: Cooling with the ZOLL® Circulation catheter and the ZOLL® Intravascular Temperature Management system to initiate and maintain hypothermia for 6 hours as an adjunct to endovascular Recanalization.
arm group label: Cooling + Recanalization
intervention type: Procedure
intervention name: Recanalization only
description: Standard of Care for recanalization
arm group label: Recanalization only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Rishi Gupta, MD, MBA
role: Principal Investigator
affiliation: Wellstar Medical Group
last name: Shweta Kalpa, MD
phone: 408-419-2357
email: skalpa@zoll.com
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
investigator: 
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Recruiting
investigator: 
facility: 
status: Completed
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Ischemia
sharing ipd: No