<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/NCT03024749</url>
  </required_header>
  <id_info>
    <org_study_id>D161100003816001</org_study_id>
    <nct_id>NCT03024749</nct_id>
  </id_info>
  <brief_title>Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas</brief_title>
  <acronym>SUIT-SAVM</acronym>
  <official_title>Surgical Intervention of Spinal Arteriovenous Malformations and Fistulas: Multicenter Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hongqi Zhang, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Tsinghua Chang Gung Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin Medical University General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Chinese Armed Police Forces</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Haidian Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China Rehabilitation Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xuanwu Hospital, Beijing</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spinal arteriovenous fistulas (AVFs) and arteriovenous malformations (AVMs) are complex&#xD;
      neurosurgical lesions that are very challenging to manage. Spinal vascular malformations&#xD;
      account for 3%-4% of all intradural spinal cord mass lesions. Over the last few decades our&#xD;
      understanding of these lesions has dramatically increased thanks to neuroimaging technology&#xD;
      (e.g. spinal angiography and indocyanine green angiography). Various treatment modalities&#xD;
      including conservative observation, endovascular embolization, microsurgical resection,&#xD;
      radiation therapy, and combined therapies have been reported. The treatment for these AVMs&#xD;
      and AVFs depends on their location, the type of malformation, the area of the spine involved,&#xD;
      and the condition of the patient at the time of treatment. Due to the rarity of these spinal&#xD;
      vascular lesions, reports of their management and outcomes have been limited to small series&#xD;
      and case reports. And the rates of obliteration and outcomes are not satisfactory, especially&#xD;
      the spinal AVMs. Spinal vascular lesions are rare but represent a formidable challenge for&#xD;
      the treating neurosurgeon.The purpose of this study is to establish multimodality treatment&#xD;
      mode and evaluate the anatomical cure rate and functional preservation rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, prospective, observational, registration study. There are nine centers&#xD;
      involved in the study. The investigators set up a more detailed classification system for&#xD;
      spinal vascular malformations. In accordance with inclusion criteria and exclusion criteria,&#xD;
      this cohort study will include 380 samples in the study period of three years. According to&#xD;
      the spinal angiography, the correct diagnosis and treatment strategy will be made. The&#xD;
      minimally invasive surgical treatment methods and new techniques will be adopted such as&#xD;
      spinal superselective angiography, preoperative embolization, intraoperative&#xD;
      electrophysiological monitoring, intraoperative angiography, etc. All the enrolled patients&#xD;
      will be visited a total of four times, postoperative day 1 and postoperative day 7, followed&#xD;
      up postoperative 3 months and 12 months. The anatomical cure rate and spinal cord function&#xD;
      will be assessed objectively. All data will be recorded in the network database platform.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Change of the spinal cord function</measure>
    <time_frame>1 day before operation and 12 months postoperative</time_frame>
    <description>American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function.Indexes (ASIA score) at baseline (1 day before operation) and 12 months follow-up will be collected, then the change from preoperative to 12 months follow-up will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anatomic obliteration rate</measure>
    <time_frame>3 months post operation</time_frame>
    <description>the anatomic obliteration rate is determined by angiography 3 months post operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Spinal Injury Association(ASIA) Score</measure>
    <time_frame>1 week, 3 months, 6 months, 12 months post operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Aminoff &amp; Logue's Scale (mALS)</measure>
    <time_frame>1 week, 3 months, 6 months, 12 months post operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Denis Pain and Numbness Scale (mDPNS)</measure>
    <time_frame>1 week, 3 months, 6 months, 12 months post operation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of perioperative complications</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">380</enrollment>
  <condition>Spinal Cord Vascular Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with spinal AVMs/AVFs&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient diagnosed with spinal vascular diseases including&#xD;
&#xD;
               -  intradural arteriovenous malformation,&#xD;
&#xD;
               -  intradural arteriovenous fistula,&#xD;
&#xD;
               -  dural arteriovenous fistula,&#xD;
&#xD;
               -  extradural arteriovenous malformation,&#xD;
&#xD;
               -  paravertebral arteriovenous malformation,&#xD;
&#xD;
               -  paravertebral arteriovenous fistula,&#xD;
&#xD;
               -  cobbs' syndrome,&#xD;
&#xD;
               -  other spinal arteriovenous metameric syndromes involve the spinal cord.&#xD;
&#xD;
          -  patient not received surgical or interventional treatment before&#xD;
&#xD;
          -  patient with normal cardiac, renal and hepatic function&#xD;
&#xD;
          -  patient capable of understanding the content of the patient information / Informed&#xD;
             Consent Form&#xD;
&#xD;
          -  patient willing and able to participate in the registry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient received surgical treatment or interventional treatment before&#xD;
&#xD;
          -  patient is pregnant&#xD;
&#xD;
          -  patient allergic to iodine&#xD;
&#xD;
          -  patient unable to complete follow-up&#xD;
&#xD;
          -  patient with cerebral lesions&#xD;
&#xD;
          -  patient with other spinal lesions&#xD;
&#xD;
          -  patient with cardiac, renal or hepatic dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhang Hongqi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Neurosurgical Department, Xuanwu Hospital, Beijing</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hong Tao, MD</last_name>
    <phone>86-13810000653</phone>
    <email>hongtao.edu@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tao Hong</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Tao, MD.</last_name>
      <phone>13810000653</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Lee YJ, Terbrugge KG, Saliou G, Krings T. Clinical features and outcomes of spinal cord arteriovenous malformations: comparison between nidus and fistulous types. Stroke. 2014 Sep;45(9):2606-12. doi: 10.1161/STROKEAHA.114.006087. Epub 2014 Jul 15.</citation>
    <PMID>25028446</PMID>
  </reference>
  <reference>
    <citation>Rangel-Castilla L, Russin JJ, Zaidi HA, Martinez-Del-Campo E, Park MS, Albuquerque FC, McDougall CG, Nakaji P, Spetzler RF. Contemporary management of spinal AVFs and AVMs: lessons learned from 110 cases. Neurosurg Focus. 2014 Sep;37(3):E14. doi: 10.3171/2014.7.FOCUS14236.</citation>
    <PMID>25175433</PMID>
  </reference>
  <reference>
    <citation>Gross BA, Du R. Spinal glomus (type II) arteriovenous malformations: a pooled analysis of hemorrhage risk and results of intervention. Neurosurgery. 2013 Jan;72(1):25-32; discussion 32. doi: 10.1227/NEU.0b013e318276b5d3.</citation>
    <PMID>23096418</PMID>
  </reference>
  <reference>
    <citation>Gross BA, Du R. Spinal pial (type IV) arteriovenous fistulae: a systematic pooled analysis of demographics, hemorrhage risk, and treatment results. Neurosurgery. 2013 Jul;73(1):141-51; discussion 151. doi: 10.1227/01.neu.0000429848.91707.73.</citation>
    <PMID>23615108</PMID>
  </reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>June 4, 2017</last_update_submitted>
  <last_update_submitted_qc>June 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Xuanwu Hospital, Beijing</investigator_affiliation>
    <investigator_full_name>Hongqi Zhang, MD</investigator_full_name>
    <investigator_title>Director of Neurosurgery</investigator_title>
  </responsible_party>
  <keyword>Spinal Arteriovenous Malformation</keyword>
  <keyword>Spinal Arteriovenous Fistula</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Vascular Diseases</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Arteriovenous Malformations</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03024749
org study id: D161100003816001
nct id: NCT03024749
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Spinal arteriovenous fistulas (AVFs) and arteriovenous malformations (AVMs) are complex
      neurosurgical lesions that are very challenging to manage. Spinal vascular malformations
      account for 3%-4% of all intradural spinal cord mass lesions. Over the last few decades our
      understanding of these lesions has dramatically increased thanks to neuroimaging technology
      (e.g. spinal angiography and indocyanine green angiography). Various treatment modalities
      including conservative observation, endovascular embolization, microsurgical resection,
      radiation therapy, and combined therapies have been reported. The treatment for these AVMs
      and AVFs depends on their location, the type of malformation, the area of the spine involved,
      and the condition of the patient at the time of treatment. Due to the rarity of these spinal
      vascular lesions, reports of their management and outcomes have been limited to small series
      and case reports. And the rates of obliteration and outcomes are not satisfactory, especially
      the spinal AVMs. Spinal vascular lesions are rare but represent a formidable challenge for
      the treating neurosurgeon.The purpose of this study is to establish multimodality treatment
      mode and evaluate the anatomical cure rate and functional preservation rate.
This is a multicenter, prospective, observational, registration study. There are nine centers
      involved in the study. The investigators set up a more detailed classification system for
      spinal vascular malformations. In accordance with inclusion criteria and exclusion criteria,
      this cohort study will include 380 samples in the study period of three years. According to
      the spinal angiography, the correct diagnosis and treatment strategy will be made. The
      minimally invasive surgical treatment methods and new techniques will be adopted such as
      spinal superselective angiography, preoperative embolization, intraoperative
      electrophysiological monitoring, intraoperative angiography, etc. All the enrolled patients
      will be visited a total of four times, postoperative day 1 and postoperative day 7, followed
      up postoperative 3 months and 12 months. The anatomical cure rate and spinal cord function
      will be assessed objectively. All data will be recorded in the network database platform.
observational model: Cohort
time perspective: Prospective
measure: Change of the spinal cord function
time frame: 1 day before operation and 12 months postoperative
description: American Spinal Injury Association(ASIA) Score for evaluating the spinal cord function.Indexes (ASIA score) at baseline (1 day before operation) and 12 months follow-up will be collected, then the change from preoperative to 12 months follow-up will be assessed.
measure: Anatomic obliteration rate
time frame: 3 months post operation
description: the anatomic obliteration rate is determined by angiography 3 months post operation.
measure: American Spinal Injury Association(ASIA) Score
time frame: 1 week, 3 months, 6 months, 12 months post operation
measure: Modified Aminoff & Logue's Scale (mALS)
time frame: 1 week, 3 months, 6 months, 12 months post operation
measure: Modified Denis Pain and Numbness Scale (mDPNS)
time frame: 1 week, 3 months, 6 months, 12 months post operation
measure: Incidence of perioperative complications
time frame: 1 week
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Zhang Hongqi, MD
role: Study Director
affiliation: Neurosurgical Department, Xuanwu Hospital, Beijing
last name: Hong Tao, MD
phone: 86-13810000653
email: hongtao.edu@gmail.com
facility: 
status: Recruiting
contact: 
country: China
citation: Lee YJ, Terbrugge KG, Saliou G, Krings T. Clinical features and outcomes of spinal cord arteriovenous malformations: comparison between nidus and fistulous types. Stroke. 2014 Sep;45(9):2606-12. doi: 10.1161/STROKEAHA.114.006087. Epub 2014 Jul 15.
PMID: 25028446
citation: Rangel-Castilla L, Russin JJ, Zaidi HA, Martinez-Del-Campo E, Park MS, Albuquerque FC, McDougall CG, Nakaji P, Spetzler RF. Contemporary management of spinal AVFs and AVMs: lessons learned from 110 cases. Neurosurg Focus. 2014 Sep;37(3):E14. doi: 10.3171/2014.7.FOCUS14236.
PMID: 25175433
citation: Gross BA, Du R. Spinal glomus (type II) arteriovenous malformations: a pooled analysis of hemorrhage risk and results of intervention. Neurosurgery. 2013 Jan;72(1):25-32; discussion 32. doi: 10.1227/NEU.0b013e318276b5d3.
PMID: 23096418
citation: Gross BA, Du R. Spinal pial (type IV) arteriovenous fistulae: a systematic pooled analysis of demographics, hemorrhage risk, and treatment results. Neurosurgery. 2013 Jul;73(1):141-51; discussion 151. doi: 10.1227/01.neu.0000429848.91707.73.
PMID: 23615108
responsible party type: Sponsor-Investigator
investigator affiliation: Xuanwu Hospital, Beijing
investigator full name: Hongqi Zhang, MD
investigator title: Director of Neurosurgery
mesh term: Spinal Cord Vascular Diseases
mesh term: Vascular Diseases
mesh term: Arteriovenous Malformations
mesh term: Congenital Abnormalities
mesh term: Fistula
sharing ipd: Undecided