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/NCT05972252</url>
    </required_header>
    <id_info>
      <org_study_id>DNS-CIPCS-01</org_study_id>
      <nct_id>NCT05972252</nct_id>
    </id_info>
    <brief_title>First-in-man Study of the Cerebrovascular Interventional Procedural Control System</brief_title>
    <official_title>A Feasibility Study to Evaluate the Safety and Efficacy of the Cerebrovascular Interventional Procedural Control System in Treatment of Acute Ischemic Stroke</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hangzhou Dinova Neuroscience Technology Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hangzhou Dinova Neuroscience Technology Co., Ltd</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>
        The objective of this study the first human use of a new device in treatment of acute&#xD;
        ischemic stroke, which to evaluate the feasibility, safety, and efficacy of the&#xD;
        Cerebrovascular Interventional Procedural Control System.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Good Neurological Outcome</measure>
      <time_frame>90±7 Days post-treatment</time_frame>
      <description>Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days.&#xD;
  mRS 0-2 indicates functional independence 0 - No symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Technical Success</measure>
      <time_frame>Immediately post-treatment</time_frame>
      <description>Using Cerebrovascular Interventional Procedural Control System successfully complete the catheters in placement, thrombectomy stent release, and thrombectomy system recovery, without manual conversion.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Successful Revascularization</measure>
      <time_frame>Immediately post-treatment</time_frame>
      <description>Achieving mTICI ≥2b in the target vessel within 3 passes of the cerebrovascular interventional procedural control system without the use of rescue therapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time from Groin Puncture to Reperfusion</measure>
      <time_frame>Immediately post-treatment</time_frame>
      <description>Time from groin puncture to achievement of mTICI ≥2b</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Successful Recanalization Rate</measure>
      <time_frame>Immediately post-treatment</time_frame>
      <description>Achieving mTICI ≥2b in the target vessel within 1 passes of the Cerebrovascular Interventional Procedural Control System without the use of rescue therapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Radiation Exposure</measure>
      <time_frame>Immediately post-treatment</time_frame>
      <description>Total fluoroscopy dose utilized during the procedure as recorded by the DSA Imaging System.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptomatic Intracranial Hemorrhage</measure>
      <time_frame>36 hours post-treatment</time_frame>
      <description>Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Device-related Serious Adverse Events (SAEs)</measure>
      <time_frame>Through 90 days</time_frame>
      <description>Any serious adverse events related to the device, such as vessel perforation, vessel dissection, vessel rupture, and severe spasm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause Mortality at 90 days</measure>
      <time_frame>Through 90 days</time_frame>
      <description>Rate of mortality</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Acute Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with acute ischemic stroke will receive interventional procedure by the Cerebrovascular Interventional Procedural Control System.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cerebrovascular Interventional Procedural Control System</intervention_name>
      <description>The Cerebrovascular Interventional Procedural Control System is intended for use in the remote delivery and manipulation of guidewires and rapid deliver stent catheters, and remote manipulation of guide catheters during cerebrovascular intervention procedures.</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-80.&#xD;
  &#xD;
            2. Diagnosed with acute ischemic stroke.&#xD;
  &#xD;
            3. Arterial occlusion in the anterior cerebral circulation that was confirmed by CTA or&#xD;
               MRA.&#xD;
  &#xD;
            4. Subject could be treated intraarterially within 8 hours after symptom onset.&#xD;
  &#xD;
            5. Prestroke Modified Rankin Score ≤ 1.&#xD;
  &#xD;
            6. National Institutes of Health Stroke Scale (NIHSS) ≥6 and ≤20.&#xD;
  &#xD;
            7. Patients or their legally authorised representatives provided signed, informed&#xD;
               consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. NCCT ASPECT score &lt;6，or the infarct volume exceeded 1/3 of the middle cerebral artery&#xD;
               blood supply area.&#xD;
  &#xD;
            2. CT/MR Showed midline shift or cerebral hernia, and ventricle occupying effect.&#xD;
               Intracranial hemorrhage. CTA/MRA shows carotid artery dissection, severe stenosis, or&#xD;
               complete occlusion, which requiring carotid stent implantation during thrombectomy;&#xD;
               Bilateral acute stroke or multiple intracranial large vessel occlusion.&#xD;
  &#xD;
            3. Females who are pregnant or lactating.&#xD;
  &#xD;
            4. Severe allergy to contrast agents, nickel-titanium metal or its alloys.&#xD;
  &#xD;
            5. Drug-resistant hypertension (defined as sustained systolic blood pressure &gt;185mmHg or&#xD;
               diastolic blood pressure &gt;110mmHg).&#xD;
  &#xD;
            6. Hemorrhagic tendency (including but not limited to platelet &lt;100*109/L, heparin&#xD;
               treatment within 48 hours with APTT ≥35s, taking warfarin with an INR &gt; 1.7).&#xD;
  &#xD;
            7. Surgery or biopsy of parenchymal organs within the last 1 month&#xD;
  &#xD;
            8. Any active or recent bleeding (gastrointestinal, urinary, etc.) within the last 1&#xD;
               month&#xD;
  &#xD;
            9. Undergoing hemodialysis or peritoneal dialysis; exist of severe renal insufficiency&#xD;
               (serum creatinine &gt;220umol/L or 2.5mg/dl)&#xD;
  &#xD;
           10. Previous intracranial hemorrhage, subarachnoid hemorrhage, brain tumor.&#xD;
  &#xD;
           11. Life expectancy of less than 1 year.&#xD;
  &#xD;
           12. Enrollment in another clinical trial evaluating other devices or drugs during the same&#xD;
               period.&#xD;
  &#xD;
           13. Abnormalities or diseases that the investigator considers to be excluded from the&#xD;
               study's coverage.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Vico Wang</last_name>
      <phone>+8657156105021</phone>
      <email>neuroscience@dnamedtech.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing Tiantan Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Feng Gao, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05972252
  org study id: DNS-CIPCS-01
  nct id: NCT05972252
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study the first human use of a new device in treatment of acute
        ischemic stroke, which to evaluate the feasibility, safety, and efficacy of the
        Cerebrovascular Interventional Procedural Control System.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Good Neurological Outcome
  time frame: 90±7 Days post-treatment
  description: Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days.
  mRS 0-2 indicates functional independence 0 - No symptoms.
  measure: Technical Success
  time frame: Immediately post-treatment
  description: Using Cerebrovascular Interventional Procedural Control System successfully complete the catheters in placement, thrombectomy stent release, and thrombectomy system recovery, without manual conversion.
  measure: Successful Revascularization
  time frame: Immediately post-treatment
  description: Achieving mTICI ≥2b in the target vessel within 3 passes of the cerebrovascular interventional procedural control system without the use of rescue therapy.
  measure: Time from Groin Puncture to Reperfusion
  time frame: Immediately post-treatment
  description: Time from groin puncture to achievement of mTICI ≥2b
  measure: Successful Recanalization Rate
  time frame: Immediately post-treatment
  description: Achieving mTICI ≥2b in the target vessel within 1 passes of the Cerebrovascular Interventional Procedural Control System without the use of rescue therapy.
  measure: Radiation Exposure
  time frame: Immediately post-treatment
  description: Total fluoroscopy dose utilized during the procedure as recorded by the DSA Imaging System.
  measure: Symptomatic Intracranial Hemorrhage
  time frame: 36 hours post-treatment
  description: Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs.
  measure: Device-related Serious Adverse Events (SAEs)
  time frame: Through 90 days
  description: Any serious adverse events related to the device, such as vessel perforation, vessel dissection, vessel rupture, and severe spasm.
  measure: All-cause Mortality at 90 days
  time frame: Through 90 days
  description: Rate of mortality
  arm group label: Experimental Group
  arm group type: Experimental
  description: Patients with acute ischemic stroke will receive interventional procedure by the Cerebrovascular Interventional Procedural Control System.
  intervention type: Device
  intervention name: Cerebrovascular Interventional Procedural Control System
  description: The Cerebrovascular Interventional Procedural Control System is intended for use in the remote delivery and manipulation of guidewires and rapid deliver stent catheters, and remote manipulation of guide catheters during cerebrovascular intervention procedures.
  arm group label: Experimental Group
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Vico Wang
  phone: +8657156105021
  email: neuroscience@dnamedtech.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Ischemic Stroke
  sharing ipd: Undecided