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/NCT06029491</url>
    </required_header>
    <id_info>
      <org_study_id>CIP-0002</org_study_id>
      <nct_id>NCT06029491</nct_id>
    </id_info>
    <brief_title>The Pivotal Study of RapidPulseTM Aspiration System</brief_title>
    <acronym>PIVOTAL</acronym>
    <official_title>The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RapidPulse, Inc</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RapidPulse, Inc</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 goal of this clinical trials is to demonstrate the safety and effectiveness for the&#xD;
        RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours&#xD;
        of symptom onset or last seen normal. Subjects will undergo mechanical thrombectomy (a&#xD;
        procedure to remove a clot in the brain which is preventing blood flow), with the&#xD;
        RapidPulseTM Aspiration System. Participation in the trial is for 90 days.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this prospective, open label clinical trials is to demonstrate the safety and&#xD;
        effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment&#xD;
        of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of&#xD;
        symptom onset or last seen normal. The target sample size for this clinical trial is 170&#xD;
        subjects enrolled in up to 30 sites globally. The maximum number of subjects that may be&#xD;
        enrolled is 340. Subjects will undergo mechanical thrombectomy procedure and will have&#xD;
        postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge&#xD;
        (whichever comes first). The final study visit will occur approximately 90 days after the&#xD;
        index event. The primary effectiveness endpoint is the proportion of patients who achieve&#xD;
        First Pass Reperfusion Effect (FPE) as defined by modified treatment in cerebral infarction&#xD;
        score (mTICI) ≥ 2c after the first pass as assessed by an independent Imaging Core Lab. The&#xD;
        primary safety endpoint is the proportion of patients with symptomatic ICH (sICH) at 24 hours&#xD;
        post-thrombectomy as assessed by a central events committee (CEC).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Effectiveness Endpoint</measure>
      <time_frame>Intra-procedural</time_frame>
      <description>The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass as assessed by an independent Imaging Core Lab.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Primary Safety Endpoint</measure>
      <time_frame>Post-procedural (24 hours post-thrombectomy)</time_frame>
      <description>The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by CEC.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Key Secondary Endpoint #1</measure>
      <time_frame>Intra-procedural</time_frame>
      <description>Proportion of patients who achieve mTICI ≥ 2b, based on the best mTICI score within a maximum of 3 passes where only aspiration with Study Device was used without rescue, as assessed by an independent Imaging Core Lab. The performance goal is 0.55.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Key Secondary Endpoint #2</measure>
      <time_frame>Intra-procedural</time_frame>
      <description>The proportion of patients achieving FPE reperfusion as defined by mTICI ≥ 2c after one reperfusion attempt as assessed by independent Imaging Core Lab. The performance goal is 0.4547.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Key Secondary Endpoint #3</measure>
      <time_frame>Post-procedure (90 days post-thrombectomy)</time_frame>
      <description>Proportion of patients who achieve mRS ≤2 at 90-days post treatment. The performance goal is 0.4578.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Technical Endpoint #1</measure>
      <time_frame>Intra-procedural</time_frame>
      <description>Modified First Pass Reperfusion Effect (mFPE) as defined by mTICI ≥ 2b after one device pass as assessed by an independent Imaging Core lab.</description>
    </other_outcome>
    <other_outcome>
      <measure>Technical Endpoint #2</measure>
      <time_frame>Intra-procedural</time_frame>
      <description>Final mTICI ≥ 2b after all passes (including any rescue therapy) at procedure conclusion as assessed by independent Imaging Core Lab.</description>
    </other_outcome>
    <other_outcome>
      <measure>Technical Endpoint #3</measure>
      <time_frame>Intra-procedural</time_frame>
      <description>Time from arterial puncture (procedure initiation) to achieve mTICI ≥ 2b using first line aspiration treatment.</description>
    </other_outcome>
    <other_outcome>
      <measure>Clinical Endpoint #1</measure>
      <time_frame>Post-procedure (24 hours post-thrombectomy)</time_frame>
      <description>Proportion of patients with major early neurological recovery at 24-hours as defined by reduction in NIHSS score from baseline of at least 8 points or reaching NIHSS 0-1.</description>
    </other_outcome>
    <other_outcome>
      <measure>Clinical Endpoint #2</measure>
      <time_frame>Pre-procedure to post-procedure (index event assessment to 24 hours post-thrombectomy)</time_frame>
      <description>Change in NIHSS score from Baseline to 24-hours.</description>
    </other_outcome>
    <other_outcome>
      <measure>Safety Endpoint #1</measure>
      <time_frame>Intra-procedural to post-procedure (through 90 days post-thrombectomy)</time_frame>
      <description>All device-related and procedure-related serious adverse events as assessed by an independent CEC.</description>
    </other_outcome>
    <other_outcome>
      <measure>Safety Endpoint #2</measure>
      <time_frame>Intra-procedural to post-procedure (through 90 days post-thrombectomy)</time_frame>
      <description>All-cause mortality assessed through 90 days post index procedure.</description>
    </other_outcome>
    <other_outcome>
      <measure>Safety Endpoint #3</measure>
      <time_frame>Intra-procedural</time_frame>
      <description>Device-related vasospasm as assessed by an independent CEC.</description>
    </other_outcome>
    <other_outcome>
      <measure>Safety Endpoint #4</measure>
      <time_frame>Intra-procedural</time_frame>
      <description>Embolism in new territory determined based on procedural angiogram as assessed by an independent Imaging Core Lab.</description>
    </other_outcome>
    <other_outcome>
      <measure>Safety Endpoint #5</measure>
      <time_frame>Post-procedural (24 hours post-thrombectomy)</time_frame>
      <description>Any intracranial hemorrhage according to the Heidelberg classification at 24-hours as assessed by an independent Imaging Core Lab.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">170</enrollment>
    <condition>Acute Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>Treatment Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each subject will undergo baseline evaluation for acute ischemic stroke due to large vessel occlusion, per standard of care and undergo mechanical thrombectomy procedure, aspiration to remove the thrombus in the neuro-vasculature using the RapidPulseTM Aspiration System.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>RapidPulseTM Aspiration System</intervention_name>
      <description>The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the occluded cerebral vasculature using precisely pulsed aspiration. The system is comprised of the multi-use, non-sterile RapidPulse TM Aspiration Pump, the single use, sterile RapidPulseTM Tube set, the single use, non-sterile RapidPulseTM Collection Canister and the single use, sterile RapidPulseTM 071 Catheter.</description>
      <arm_group_label>Treatment Arm</arm_group_label>
      <other_name>Aspiration Thrombectomy</other_name>
      <other_name>Thrombectomy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 to 80 years&#xD;
  &#xD;
            -  Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6&#xD;
  &#xD;
            -  Able to be treated within 8 hours of symptom onset or last known normal (LKN)&#xD;
  &#xD;
            -  Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR&#xD;
               image&#xD;
  &#xD;
            -  Pre-morbid Modified Rankin Scale (mRS) score 0-1&#xD;
  &#xD;
            -  Angiographic confirmation of large vessel occlusion (LVO) in the anterior&#xD;
               (intracranial ICA or MCA M1 or M2 segments) or posterior circulation (vertebral or&#xD;
               basilar arteries) as confirmed by digital subtraction angiography (DSA) irrespective&#xD;
               of IV thrombolysis administration&#xD;
  &#xD;
            -  Candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass&#xD;
               Technique)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intracranial Hemorrhage (ICH)&#xD;
  &#xD;
            -  Alberta Stroke Program Early CT Score (ASPECTS) &lt;6&#xD;
  &#xD;
            -  Intracranial Atherosclerotic Disease (ICAD)&#xD;
  &#xD;
            -  Multiple or tandem occlusions&#xD;
  &#xD;
            -  Life expectancy less than 90 days&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Raul G Nogueira, MD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Pittsburgh Medical Center Stroke Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cynthia Yang</last_name>
      <phone>9498367402</phone>
      <email>cyang@rapidpulsemed.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Istanbul Aydan University VM MedicalPark Florya</name>
        <address>
          <city>Istanbul</city>
          <zip>34295</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Ata Aydincan</last_name>
        <phone>0090 532 413 20 86</phone>
        <email>aaydincan@croturk.com</email>
      </contact>
      <investigator>
        <last_name>Serdar Geyik, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Stroke</keyword>
    <keyword>Large Vessel Occlusion</keyword>
    <keyword>Mechanical Thrombectomy</keyword>
    <keyword>Neurovascular Intervention</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>No</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/NCT06029491
  org study id: CIP-0002
  nct id: NCT06029491
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trials is to demonstrate the safety and effectiveness for the
        RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours
        of symptom onset or last seen normal. Subjects will undergo mechanical thrombectomy (a
        procedure to remove a clot in the brain which is preventing blood flow), with the
        RapidPulseTM Aspiration System. Participation in the trial is for 90 days.
  The purpose of this prospective, open label clinical trials is to demonstrate the safety and
        effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment
        of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of
        symptom onset or last seen normal. The target sample size for this clinical trial is 170
        subjects enrolled in up to 30 sites globally. The maximum number of subjects that may be
        enrolled is 340. Subjects will undergo mechanical thrombectomy procedure and will have
        postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge
        (whichever comes first). The final study visit will occur approximately 90 days after the
        index event. The primary effectiveness endpoint is the proportion of patients who achieve
        First Pass Reperfusion Effect (FPE) as defined by modified treatment in cerebral infarction
        score (mTICI) ≥ 2c after the first pass as assessed by an independent Imaging Core Lab. The
        primary safety endpoint is the proportion of patients with symptomatic ICH (sICH) at 24 hours
        post-thrombectomy as assessed by a central events committee (CEC).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Primary Effectiveness Endpoint
  time frame: Intra-procedural
  description: The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass as assessed by an independent Imaging Core Lab.
  measure: Primary Safety Endpoint
  time frame: Post-procedural (24 hours post-thrombectomy)
  description: The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by CEC.
  measure: Key Secondary Endpoint #1
  time frame: Intra-procedural
  description: Proportion of patients who achieve mTICI ≥ 2b, based on the best mTICI score within a maximum of 3 passes where only aspiration with Study Device was used without rescue, as assessed by an independent Imaging Core Lab. The performance goal is 0.55.
  measure: Key Secondary Endpoint #2
  time frame: Intra-procedural
  description: The proportion of patients achieving FPE reperfusion as defined by mTICI ≥ 2c after one reperfusion attempt as assessed by independent Imaging Core Lab. The performance goal is 0.4547.
  measure: Key Secondary Endpoint #3
  time frame: Post-procedure (90 days post-thrombectomy)
  description: Proportion of patients who achieve mRS ≤2 at 90-days post treatment. The performance goal is 0.4578.
  measure: Technical Endpoint #1
  time frame: Intra-procedural
  description: Modified First Pass Reperfusion Effect (mFPE) as defined by mTICI ≥ 2b after one device pass as assessed by an independent Imaging Core lab.
  measure: Technical Endpoint #2
  time frame: Intra-procedural
  description: Final mTICI ≥ 2b after all passes (including any rescue therapy) at procedure conclusion as assessed by independent Imaging Core Lab.
  measure: Technical Endpoint #3
  time frame: Intra-procedural
  description: Time from arterial puncture (procedure initiation) to achieve mTICI ≥ 2b using first line aspiration treatment.
  measure: Clinical Endpoint #1
  time frame: Post-procedure (24 hours post-thrombectomy)
  description: Proportion of patients with major early neurological recovery at 24-hours as defined by reduction in NIHSS score from baseline of at least 8 points or reaching NIHSS 0-1.
  measure: Clinical Endpoint #2
  time frame: Pre-procedure to post-procedure (index event assessment to 24 hours post-thrombectomy)
  description: Change in NIHSS score from Baseline to 24-hours.
  measure: Safety Endpoint #1
  time frame: Intra-procedural to post-procedure (through 90 days post-thrombectomy)
  description: All device-related and procedure-related serious adverse events as assessed by an independent CEC.
  measure: Safety Endpoint #2
  time frame: Intra-procedural to post-procedure (through 90 days post-thrombectomy)
  description: All-cause mortality assessed through 90 days post index procedure.
  measure: Safety Endpoint #3
  time frame: Intra-procedural
  description: Device-related vasospasm as assessed by an independent CEC.
  measure: Safety Endpoint #4
  time frame: Intra-procedural
  description: Embolism in new territory determined based on procedural angiogram as assessed by an independent Imaging Core Lab.
  measure: Safety Endpoint #5
  time frame: Post-procedural (24 hours post-thrombectomy)
  description: Any intracranial hemorrhage according to the Heidelberg classification at 24-hours as assessed by an independent Imaging Core Lab.
  arm group label: Treatment Arm
  arm group type: Experimental
  description: Each subject will undergo baseline evaluation for acute ischemic stroke due to large vessel occlusion, per standard of care and undergo mechanical thrombectomy procedure, aspiration to remove the thrombus in the neuro-vasculature using the RapidPulseTM Aspiration System.
  intervention type: Device
  intervention name: RapidPulseTM Aspiration System
  description: The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the occluded cerebral vasculature using precisely pulsed aspiration. The system is comprised of the multi-use, non-sterile RapidPulse TM Aspiration Pump, the single use, sterile RapidPulseTM Tube set, the single use, non-sterile RapidPulseTM Collection Canister and the single use, sterile RapidPulseTM 071 Catheter.
  arm group label: Treatment Arm
  other name: Aspiration Thrombectomy
  other name: Thrombectomy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Raul G Nogueira, MD
  role: Study Chair
  affiliation: University of Pittsburgh Medical Center Stroke Institute
  last name: Cynthia Yang
  phone: 9498367402
  email: cyang@rapidpulsemed.com
  facility: 
  contact: 
  investigator: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Ischemic Stroke
  sharing ipd: No