<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/NCT03774017</url>
  </required_header>
  <id_info>
    <org_study_id>BJTTH-007</org_study_id>
    <secondary_id>2016YFC1301801</secondary_id>
    <nct_id>NCT03774017</nct_id>
  </id_info>
  <brief_title>Research on Hybrid Operation Technique in the Treatment of Complex Brain Arteriovenous Malformations</brief_title>
  <acronym>HOTAVM</acronym>
  <official_title>Study on Benefits and Risks of Hybrid Operation in the Treatment of Complex Brain Arteriovenous Malformations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ministry of Science and Technology of the People´s Republic of China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ministry of Science and Technology of the People´s Republic of China</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>
      Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been&#xD;
      challenges among cerebrovascular diseases. None of the traditional methods, such as&#xD;
      microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can&#xD;
      completely eliminate complex bAVMs without a risk of neural function deterioration. The&#xD;
      multistaged hybrid operation solved part of the challenge but remained risky in the&#xD;
      installment procedures and intervals. The one-staged hybrid operation was applied in the&#xD;
      surgical treatment of cerebrovascular diseases and proved to be a potentially safe and&#xD;
      effective method for curing complex bAVMs. However, lacking the support of high-level&#xD;
      evidence, its advantages remain unclear. This study was proposed to validate the benefits and&#xD;
      risks of one-staged hybrid operation in the treatment of complex bAVMs, as well as its&#xD;
      indications, key technologies, and workflows.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation units. It consists&#xD;
      of 2 sets. The registry set is designed as a prospective real-world registry. The trial set&#xD;
      is designed as a prospective pragmatic clinical trial, specifically for the patients with&#xD;
      perforating arterial feeders. The two sets share a common grouping: the traditional operation&#xD;
      group and the one-staged hybrid operation group. The assignment is based on the clinical&#xD;
      condition in the registry set and is randomized in the trial set. End points will be&#xD;
      evaluated at scheduled time points. The safety and efficiency of one-staged hybrid operation&#xD;
      in treating complex bAVMs will be validated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>neural function deterioration</measure>
    <time_frame>3 months after operation</time_frame>
    <description>Increasing of mRS and mRS&gt;2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>neural function deterioration in 6 months</measure>
    <time_frame>6 months after operation</time_frame>
    <description>Increasing of mRS and mRS&gt;2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neural function deterioration in 12 months</measure>
    <time_frame>12 months after operation</time_frame>
    <description>Increasing of mRS and mRS&gt;2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative mortality</measure>
    <time_frame>7 days after operation</time_frame>
    <description>the fatality due to operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operation-related complications</measure>
    <time_frame>7 days after operation</time_frame>
    <description>any complications that occur within 7 days from the date of operation, including intracranial hemorrhage or infarction, infection of the central nervous system, infection of the respiratory system, cranial nerve deficits, and other symptomatic complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative bAVMs residue</measure>
    <time_frame>7 days after operation</time_frame>
    <description>the bAVMs residue revealed by postoperative DSA or computed tomographic angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3 months bAVMs residue</measure>
    <time_frame>3 months after operation</time_frame>
    <description>the bAVMs residue revealed by postoperative DSA or computed tomographic angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 months bAVMs residue</measure>
    <time_frame>6 months after operation</time_frame>
    <description>the bAVMs residue revealed by postoperative DSA or computed tomographic angiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 months bAVMs residue</measure>
    <time_frame>12 months after operation</time_frame>
    <description>the bAVMs residue revealed by postoperative DSA or computed tomographic angiography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Cerebrovascular Disease</condition>
  <condition>Arteriovenous Malformations</condition>
  <condition>Complex; Primary</condition>
  <arm_group>
    <arm_group_label>Traditional microsurgery group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients receive only traditional microsurgical operations in traditional operating theaters or the one-staged hybrid operation theater. No endovascular intervention technique or intraoperative digital subtraction angiography(DSA) will be performed. The DSA will be performed in 3 days after the operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hybrid operation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>one-staged hybrid operation</intervention_name>
    <description>An integrated procedure that consists of microsurgery, intraoperative DSA, endovascular intervention techniques and other assistance tools. All the procedures are performed in a one-staged operation without any intermission or any transfer of patients.</description>
    <arm_group_label>Hybrid operation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Traditional microsurgical operation</intervention_name>
    <description>The classical mode of operations in neurosurgery. The operation is performed with neurosurgical instruments and microscope. Some of assisting tools can be used in the operation, such as neuro-navigation, Doppler probe, neural electrophysiological monitoring and so on. But neither the intraoperative DSA nor endovascular intervention techniques is used in the operation</description>
    <arm_group_label>Traditional microsurgery group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients of all ages;&#xD;
&#xD;
          2. diagnosed with arteriovenous malformations (AVMs) in brain parenchyma (including&#xD;
             cerebrum and cerebellum) by DSA, with/without dura arteriovenous fistula;&#xD;
&#xD;
          3. with any operative indications as follows: (1) with stable hematoma or history of&#xD;
             hemorrhage due to bAVMs, and allowed selective operation; (2) with recurrent epilepsy&#xD;
             seizure, having failed treatment with antiepileptic drugs (AEDs); (3) with induced&#xD;
             deterioration of neurological functions;&#xD;
&#xD;
          4. with Spetzler-Martin Grades from I to IV;&#xD;
&#xD;
          5. who provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. &gt;70 years old with no significant hemorrhagic risk of bAVMs;&#xD;
&#xD;
          2. with Spetzler-Martin Grade ≥V;&#xD;
&#xD;
          3. accompanied by severe chronic disease, organ dysfunction, or malignant tumor that&#xD;
             cannot tolerate the operation;&#xD;
&#xD;
          4. allergic to iodinated contrast agent;&#xD;
&#xD;
          5. unable to give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shuo Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tiantan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shuo Wang, MD</last_name>
    <phone>861059976510</phone>
    <email>captain9858@vip.sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jun Wu, MD</last_name>
    <phone>861059976510</phone>
    <email>wujunslf@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xuanwu Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guilin Li, MD</last_name>
      <phone>861083198899</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100070</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuo Wang, MD</last_name>
      <phone>861059976510</phone>
      <email>captain9858@vip.sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Jun Wu, MD</last_name>
      <phone>861059976510</phone>
      <email>wujunslf@126.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>General Hospital of Rocket Army</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100088</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weijian Jiang, MD</last_name>
      <phone>861066343337</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donghai Wang, MD</last_name>
      <phone>8653182166173</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Qingdao Municipal Hospital</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chuanfeng Li, MD</last_name>
      <phone>8653282789017</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liang Chen, MD</last_name>
      <phone>860215288999</phone>
      <email>chenlianghs@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gao Chen, MD</last_name>
      <phone>8657187783777</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Science and Technology of the People´s Republic of China</investigator_affiliation>
    <investigator_full_name>Shuo Wang</investigator_full_name>
    <investigator_title>Director of Neurosurgery Department</investigator_title>
  </responsible_party>
  <keyword>brain arteriovenous malformations</keyword>
  <keyword>one-staged hybrid operation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemangioma</mesh_term>
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Arteriovenous Malformations</mesh_term>
    <mesh_term>Congenital Abnormalities</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/NCT03774017
org study id: BJTTH-007
secondary id: 2016YFC1301801
nct id: NCT03774017
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Complex brain arteriovenous malformations (bAVMs) in ≥3 Spetzler-Martin grades have long been
      challenges among cerebrovascular diseases. None of the traditional methods, such as
      microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can
      completely eliminate complex bAVMs without a risk of neural function deterioration. The
      multistaged hybrid operation solved part of the challenge but remained risky in the
      installment procedures and intervals. The one-staged hybrid operation was applied in the
      surgical treatment of cerebrovascular diseases and proved to be a potentially safe and
      effective method for curing complex bAVMs. However, lacking the support of high-level
      evidence, its advantages remain unclear. This study was proposed to validate the benefits and
      risks of one-staged hybrid operation in the treatment of complex bAVMs, as well as its
      indications, key technologies, and workflows.
The study is being conducted from Jan 2016 to Dec 2020 with 20 cooperation units. It consists
      of 2 sets. The registry set is designed as a prospective real-world registry. The trial set
      is designed as a prospective pragmatic clinical trial, specifically for the patients with
      perforating arterial feeders. The two sets share a common grouping: the traditional operation
      group and the one-staged hybrid operation group. The assignment is based on the clinical
      condition in the registry set and is randomized in the trial set. End points will be
      evaluated at scheduled time points. The safety and efficiency of one-staged hybrid operation
      in treating complex bAVMs will be validated.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: neural function deterioration
time frame: 3 months after operation
description: Increasing of mRS and mRS>2
measure: neural function deterioration in 6 months
time frame: 6 months after operation
description: Increasing of mRS and mRS>2
measure: neural function deterioration in 12 months
time frame: 12 months after operation
description: Increasing of mRS and mRS>2
measure: postoperative mortality
time frame: 7 days after operation
description: the fatality due to operation
measure: operation-related complications
time frame: 7 days after operation
description: any complications that occur within 7 days from the date of operation, including intracranial hemorrhage or infarction, infection of the central nervous system, infection of the respiratory system, cranial nerve deficits, and other symptomatic complications
measure: postoperative bAVMs residue
time frame: 7 days after operation
description: the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
measure: 3 months bAVMs residue
time frame: 3 months after operation
description: the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
measure: 6 months bAVMs residue
time frame: 6 months after operation
description: the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
measure: 12 months bAVMs residue
time frame: 12 months after operation
description: the bAVMs residue revealed by postoperative DSA or computed tomographic angiography
arm group label: Traditional microsurgery group
arm group type: Other
description: Patients receive only traditional microsurgical operations in traditional operating theaters or the one-staged hybrid operation theater. No endovascular intervention technique or intraoperative digital subtraction angiography(DSA) will be performed. The DSA will be performed in 3 days after the operation.
arm group label: Hybrid operation group
arm group type: Experimental
description: Patients receive microsurgical operation under the assistance of intraoperative DSA, endovascular embolization and/or balloon occlusion in the one-staged hybrid operating theater.
intervention type: Procedure
intervention name: one-staged hybrid operation
description: An integrated procedure that consists of microsurgery, intraoperative DSA, endovascular intervention techniques and other assistance tools. All the procedures are performed in a one-staged operation without any intermission or any transfer of patients.
arm group label: Hybrid operation group
intervention type: Procedure
intervention name: Traditional microsurgical operation
description: The classical mode of operations in neurosurgery. The operation is performed with neurosurgical instruments and microscope. Some of assisting tools can be used in the operation, such as neuro-navigation, Doppler probe, neural electrophysiological monitoring and so on. But neither the intraoperative DSA nor endovascular intervention techniques is used in the operation
arm group label: Traditional microsurgery group
criteria: 
gender: All
minimum age: N/A
maximum age: 70 Years
healthy volunteers: No
last name: Shuo Wang, MD
role: Principal Investigator
affiliation: Beijing Tiantan Hospital
last name: Shuo Wang, MD
phone: 861059976510
email: captain9858@vip.sina.com
last name: Jun Wu, MD
phone: 861059976510
email: wujunslf@126.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Ministry of Science and Technology of the People´s Republic of China
investigator full name: Shuo Wang
investigator title: Director of Neurosurgery Department
mesh term: Hemangioma
mesh term: Cerebrovascular Disorders
mesh term: Arteriovenous Malformations
mesh term: Congenital Abnormalities
sharing ipd: No