<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/NCT01717755</url>
  </required_header>
  <id_info>
    <org_study_id>NL33550.100.10</org_study_id>
    <secondary_id>NHS2010B151</secondary_id>
    <secondary_id>2010-023507-95</secondary_id>
    <nct_id>NCT01717755</nct_id>
  </id_info>
  <brief_title>Basilar Artery International Cooperation Study</brief_title>
  <acronym>BASICS</acronym>
  <official_title>Basilar Artery International Cooperation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erik van der Hoeven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BASICS Study Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Antonius Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Recently our study group reported the results of the Basilar Artery International&#xD;
      Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic&#xD;
      basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we&#xD;
      continue to lack a proven treatment modality for patients with an acute BAO and that current&#xD;
      clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial&#xD;
      thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute&#xD;
      symptomatic BAO is challenged by our data. The BASICS registry was observational and has all&#xD;
      the limitations of a non-randomised study. Interpretation of results is hampered by the lack&#xD;
      of a standard treatment protocol for all patients who entered the study.&#xD;
&#xD;
      Objective: Evaluate the efficacy and safety of IAT in addition to best medical management&#xD;
      (BMM) in patients with basilar artery occlusion.&#xD;
&#xD;
      Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.&#xD;
&#xD;
      Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar&#xD;
      occlusion.&#xD;
&#xD;
      Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone.&#xD;
      IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of&#xD;
      BMM, IVT should be started within 4.5 hours of estimated time of BAO.&#xD;
&#xD;
      Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin&#xD;
      Score (mRS - functional scale) of 0-3.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Favourable outcome</measure>
    <time_frame>day 90</time_frame>
    <description>Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Excellent outcome</measure>
    <time_frame>day 90</time_frame>
    <description>Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Score</measure>
    <time_frame>day 90</time_frame>
    <description>Modified Rankin Score - not dichotomized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIHSS</measure>
    <time_frame>pre IVT, pre randomization, 24h post treatment</time_frame>
    <description>National Institutes of Health Stroke Scale (NIHSS - acute assessment scale) at timepoints:&#xD;
directly pre intravenous thrombolysis&#xD;
directly pre randomization (post intravenous thrombolysis)&#xD;
at 24 hours +- 6 hours post treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>day 90 and 12 months</time_frame>
    <description>EQ-5D (quality of life) at day 90 and at 12 months.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Recanalization</measure>
    <time_frame>24 hours ± 6 hours</time_frame>
    <description>Recanalization at 24 hours ± 6 hours, by CT angiography.</description>
  </other_outcome>
  <other_outcome>
    <measure>Volume of cerebral infarction</measure>
    <time_frame>24 hours ± 6 hours</time_frame>
    <description>Volume of cerebral infarction on NCCT and CTA source images.</description>
  </other_outcome>
  <other_outcome>
    <measure>SICH</measure>
    <time_frame>24 hours ± 6 hours.</time_frame>
    <description>Symptomatic intracranial hemorrhage at 24 hours CT imaging ± 6 hours.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mortality</measure>
    <time_frame>90 days</time_frame>
    <description>Mortality at 90 days.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">282</enrollment>
  <condition>Basilar Artery Thrombosis</condition>
  <condition>Basilar Artery Embolism</condition>
  <condition>Stroke of Basilar Artery</condition>
  <condition>Stroke</condition>
  <condition>Cerebrovascular Disorders</condition>
  <condition>Basilar Artery Occlusion</condition>
  <arm_group>
    <arm_group_label>Best medical management.</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Best medical management consists of the standard of care of patients with acute ischemic stroke according to existing local protocols and guidelines, and may include IV thrombolysis.&#xD;
If treated with IVT as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Additional intra-arterial treatment.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Best medical management followed by intra-arterial treatment and best medical management</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intra-arterial treatment</intervention_name>
    <description>IA therapy has to be initiated within 6 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of IA strategy wil be made by the treating neurointerventionalist. Choice of therapy depends on local approval and experience. If IA thrombolysis is the chosen strategy, a maximum of 22 mg of IA rt-PA or 1.500.000 Units of Urokinase may be given. Stenting is allowed in the presence of a high-grade vertebral artery stenosis or occlusion hampering adequate endovascular access to the basilar artery and in case of a residual high-grade basilar artery stenosis. The use of any other treatment strategy depends on local approval and experience, and is only allowed after prior approval of the steering committee.</description>
    <arm_group_label>Additional intra-arterial treatment.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Symptoms and signs compatible with ischemia in the basilar artery territory.&#xD;
&#xD;
          -  Basilar artery occlusion (BAO) confirmed by CTA or MRA.&#xD;
&#xD;
          -  Age 18 years or older (i.e., candidates must have had their 18th birthday).&#xD;
&#xD;
          -  If IVT is considered as part of best medical management, IVT should be started within&#xD;
             4.5 hours of estimated time of BAO. (Estimated time of BAO is defined as time of onset&#xD;
             of acute symptoms leading to clinical diagnosis of BAO or if not known last time&#xD;
             patient was seen normal prior to onset of these symptoms).&#xD;
&#xD;
          -  Initiation of IAT should be feasible within 6 hours of estimated time of BAO.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Pre-existing dependency with mRankin ≥3.&#xD;
&#xD;
          -  Females of childbearing potential who are known to be pregnant and/or lactating or who&#xD;
             have positive pregnancy tests on admission.&#xD;
&#xD;
          -  Patients who require hemodialysis or peritoneal dialysis.&#xD;
&#xD;
          -  Other serious, advanced, or terminal illness.&#xD;
&#xD;
          -  Any other condition that the investigator feels would pose a significant hazard to the&#xD;
             patient if thrombolytic therapy is initiated.&#xD;
&#xD;
          -  Current participation in another research drug treatment protocol (patient cannot&#xD;
             start another experimental agent until after 90 days).&#xD;
&#xD;
          -  Informed consent is not or cannot be obtained.&#xD;
&#xD;
        Imaging exclusion criteria&#xD;
&#xD;
          -  High-density lesion consistent with hemorrhage of any degree.&#xD;
&#xD;
          -  Significant cerebellar mass effect or acute hydrocephalus.&#xD;
&#xD;
          -  Bilateral extended brainstem ischemia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>W J Schonewille, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ST. Antonius hospital Nieuwegein</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wouter Schonewille, MD</last_name>
    <phone>+31 6 41285149</phone>
    <email>w.schonewille@antoniusziekenhuis.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Erik van der Hoeven, MD</last_name>
    <phone>+31 6 47490060</phone>
    <email>e.van.der.hoeven@antoniusziekenhuis.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fortaleza General Hospital</name>
      <address>
        <city>Fortaleza</city>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>F Mont Alverne</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas de Ribeirao Preto</name>
      <address>
        <city>Ribeirão Preto</city>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>O Pontes Neto</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum Augsburg</name>
      <address>
        <city>Augsburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hauke Schneider</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Berlin Charite Hospital</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Heinrich Audebert, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dresden University Hospital</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Volker Puetz, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Medical Center Mannheim</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Oberschwabenklinik</name>
      <address>
        <city>Ravensburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Bergamo Hospital</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Bruno Censori, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Genova Hospital</name>
      <address>
        <city>Genua</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Laura Malfatto, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Modena</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Andrea Zini, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Santa Corona Hospital</name>
      <address>
        <city>Pietra Ligure</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>T. Tassinari</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Roma Umberto I</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Varese Hospital</name>
      <address>
        <city>Varese</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>M.L. DeLodovici, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rijnstate</name>
      <address>
        <city>Arnhem</city>
        <state>Gelderland</state>
        <zip>6800 TA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Academic Hospital Maastricht</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Julie Staals, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Elisabeth Hospital</name>
      <address>
        <city>Tilburg</city>
        <state>Noord Brabant</state>
        <zip>5022 GC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Paul de Kort, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1105AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Paul Nederkoorn, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Antonius Hospital</name>
      <address>
        <city>Nieuwegein</city>
        <state>Utrecht</state>
        <zip>3430 EM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Wouter Schonewille, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MCH Westeinde</name>
      <address>
        <city>The Hague</city>
        <state>Zuid-Holland</state>
        <zip>2512 VA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jelis Boiten, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Leiden University Hospital</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Marieke Wermer, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diederik Dippel</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Haga Hospital</name>
      <address>
        <city>The Hague</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Karlijn de Laat, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitary Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jaap Kappelle, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital North Norway</name>
      <address>
        <city>Tromso</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Stein Harald Johnsen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Olavs Hospital Trondheim</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Gitta Rohweder, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of Lausanne</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>CH-1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Patrik Michel, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://basicstrial.com</url>
    <description>Website BASICS trial</description>
  </link>
  <reference>
    <citation>Schonewille WJ, Wijman CA, Michel P, Rueckert CM, Weimar C, Mattle HP, Engelter ST, Tanne D, Muir KW, Molina CA, Thijs V, Audebert H, Pfefferkorn T, Szabo K, Lindsberg PJ, de Freitas G, Kappelle LJ, Algra A; BASICS study group. Treatment and outcomes of acute basilar artery occlusion in the Basilar Artery International Cooperation Study (BASICS): a prospective registry study. Lancet Neurol. 2009 Aug;8(8):724-30. doi: 10.1016/S1474-4422(09)70173-5. Epub 2009 Jul 3.</citation>
    <PMID>19577962</PMID>
  </reference>
  <reference>
    <citation>Greving JP, Schonewille WJ, Wijman CA, Michel P, Kappelle LJ, Algra A; BASICS Study Group. Predicting outcome after acute basilar artery occlusion based on admission characteristics. Neurology. 2012 Apr 3;78(14):1058-63. doi: 10.1212/WNL.0b013e31824e8f40. Epub 2012 Mar 21.</citation>
    <PMID>22442438</PMID>
  </reference>
  <reference>
    <citation>Vergouwen MD, Compter A, Tanne D, Engelter ST, Audebert H, Thijs V, de Freitas G, Algra A, Jaap Kappelle L, Schonewille WJ. Outcomes of basilar artery occlusion in patients aged 75 years or older in the Basilar Artery International Cooperation Study. J Neurol. 2012 Nov;259(11):2341-6. doi: 10.1007/s00415-012-6498-2. Epub 2012 Apr 18.</citation>
    <PMID>22527236</PMID>
  </reference>
  <reference>
    <citation>Puetz V, Khomenko A, Hill MD, Dzialowski I, Michel P, Weimar C, Wijman CA, Mattle HP, Engelter ST, Muir KW, Pfefferkorn T, Tanne D, Szabo K, Kappelle LJ, Algra A, von Kummer R, Demchuk AM, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Group. Extent of hypoattenuation on CT angiography source images in basilar artery occlusion: prognostic value in the Basilar Artery International Cooperation Study. Stroke. 2011 Dec;42(12):3454-9. doi: 10.1161/STROKEAHA.111.622175. Epub 2011 Sep 29.</citation>
    <PMID>21960577</PMID>
  </reference>
  <reference>
    <citation>Arnold M, Fischer U, Compter A, Gralla J, Findling O, Mattle HP, Kappelle LJ, Tanne D, Algra A, Schonewille WJ; BASICS Study Group. Acute basilar artery occlusion in the Basilar Artery International Cooperation Study: does gender matter? Stroke. 2010 Nov;41(11):2693-6. doi: 10.1161/STROKEAHA.110.594036. Epub 2010 Oct 14.</citation>
    <PMID>20947845</PMID>
  </reference>
  <reference>
    <citation>Schonewille WJ, Wijman CA, Michel P, Algra A, Kappelle LJ; BASICS Study Group. The basilar artery international cooperation study (BASICS). Int J Stroke. 2007 Aug;2(3):220-3. doi: 10.1111/j.1747-4949.2007.00145.x.</citation>
    <PMID>18705948</PMID>
  </reference>
  <reference>
    <citation>Schonewille W, Wijman C, Michel P; BASICS investigators. Treatment and clinical outcome in patients with basilar artery occlusion. Stroke. 2006 Sep;37(9):2206; author reply 2207. doi: 10.1161/01.STR.0000237127.84408.c0. Epub 2006 Aug 10. No abstract available.</citation>
    <PMID>16902170</PMID>
  </reference>
  <reference>
    <citation>Vergouwen MD, Algra A, Pfefferkorn T, Weimar C, Rueckert CM, Thijs V, Kappelle LJ, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Study Group. Time is brain(stem) in basilar artery occlusion. Stroke. 2012 Nov;43(11):3003-6. doi: 10.1161/STROKEAHA.112.666867. Epub 2012 Sep 18.</citation>
    <PMID>22989501</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>January 16, 2018</last_update_submitted>
  <last_update_submitted_qc>January 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>St. Antonius Hospital</investigator_affiliation>
    <investigator_full_name>Erik van der Hoeven</investigator_full_name>
    <investigator_title>E.J.R.J. van der Hoeven, MD</investigator_title>
  </responsible_party>
  <keyword>basilar</keyword>
  <keyword>stroke</keyword>
  <keyword>mechanical</keyword>
  <keyword>thrombolysis</keyword>
  <keyword>intra-arterial</keyword>
  <keyword>trombectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <!-- 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/NCT01717755
org study id: NL33550.100.10
secondary id: NHS2010B151
secondary id: 2010-023507-95
nct id: NCT01717755
lead sponsor: 
collaborator: 
has dmc: Yes
Rationale: Recently our study group reported the results of the Basilar Artery International
      Cooperation Study (BASICS), a prospective registry of patients with an acute symptomatic
      basilar artery occlusion (BAO). Our observations in the BASICS registry underscore that we
      continue to lack a proven treatment modality for patients with an acute BAO and that current
      clinical practice varies widely. Furthermore, the often-held assumption that intra-arterial
      thrombolysis (IAT) is superior to intravenous thrombolysis (IVT) in patients with an acute
      symptomatic BAO is challenged by our data. The BASICS registry was observational and has all
      the limitations of a non-randomised study. Interpretation of results is hampered by the lack
      of a standard treatment protocol for all patients who entered the study.

      Objective: Evaluate the efficacy and safety of IAT in addition to best medical management
      (BMM) in patients with basilar artery occlusion.

      Study design: Randomised, multi-centre, open label, controlled phase III, treatment trial.

      Study population: Patients, aged 18 years and older, with CTA or MRA confirmed basilar
      occlusion.

      Intervention: Patients will be randomised between BMM with additional IAT versus BMM alone.
      IAT has to be initiated within 6 hours from estimated time of BAO. If treated with as part of
      BMM, IVT should be started within 4.5 hours of estimated time of BAO.

      Main study parameters/endpoints: Favorable outcome at day 90 defined as a modified Rankin
      Score (mRS - functional scale) of 0-3.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Favourable outcome
time frame: day 90
description: Favourable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3.
measure: Excellent outcome
time frame: day 90
description: Excellent outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-2.
measure: Modified Rankin Score
time frame: day 90
description: Modified Rankin Score - not dichotomized.
measure: NIHSS
time frame: pre IVT, pre randomization, 24h post treatment
description: National Institutes of Health Stroke Scale (NIHSS - acute assessment scale) at timepoints:
directly pre intravenous thrombolysis
directly pre randomization (post intravenous thrombolysis)
at 24 hours +- 6 hours post treatment.
measure: EQ-5D
time frame: day 90 and 12 months
description: EQ-5D (quality of life) at day 90 and at 12 months.
measure: Recanalization
time frame: 24 hours ± 6 hours
description: Recanalization at 24 hours ± 6 hours, by CT angiography.
measure: Volume of cerebral infarction
time frame: 24 hours ± 6 hours
description: Volume of cerebral infarction on NCCT and CTA source images.
measure: SICH
time frame: 24 hours ± 6 hours.
description: Symptomatic intracranial hemorrhage at 24 hours CT imaging ± 6 hours.
measure: Mortality
time frame: 90 days
description: Mortality at 90 days.
arm group label: Best medical management.
arm group type: No Intervention
description: Best medical management consists of the standard of care of patients with acute ischemic stroke according to existing local protocols and guidelines, and may include IV thrombolysis.
If treated with IVT as part of BMM, IVT should be started within 4.5 hours of estimated time of BAO.
arm group label: Additional intra-arterial treatment.
arm group type: Experimental
description: Best medical management followed by intra-arterial treatment and best medical management
intervention type: Other
intervention name: Intra-arterial treatment
description: IA therapy has to be initiated within 6 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of IA strategy wil be made by the treating neurointerventionalist. Choice of therapy depends on local approval and experience. If IA thrombolysis is the chosen strategy, a maximum of 22 mg of IA rt-PA or 1.500.000 Units of Urokinase may be given. Stenting is allowed in the presence of a high-grade vertebral artery stenosis or occlusion hampering adequate endovascular access to the basilar artery and in case of a residual high-grade basilar artery stenosis. The use of any other treatment strategy depends on local approval and experience, and is only allowed after prior approval of the steering committee.
arm group label: Additional intra-arterial treatment.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: W J Schonewille, MD
role: Principal Investigator
affiliation: ST. Antonius hospital Nieuwegein
last name: Wouter Schonewille, MD
phone: +31 6 41285149
email: w.schonewille@antoniusziekenhuis.nl
last name: Erik van der Hoeven, MD
phone: +31 6 47490060
email: e.van.der.hoeven@antoniusziekenhuis.nl
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
investigator: 
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status: Terminated
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status: Terminated
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Withdrawn
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status: Recruiting
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facility: 
status: Suspended
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
investigator: 
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status: Recruiting
investigator: 
country: Brazil
country: Germany
country: Italy
country: Netherlands
country: Norway
country: Switzerland
url: http://basicstrial.com
description: Website BASICS trial
citation: Schonewille WJ, Wijman CA, Michel P, Rueckert CM, Weimar C, Mattle HP, Engelter ST, Tanne D, Muir KW, Molina CA, Thijs V, Audebert H, Pfefferkorn T, Szabo K, Lindsberg PJ, de Freitas G, Kappelle LJ, Algra A; BASICS study group. Treatment and outcomes of acute basilar artery occlusion in the Basilar Artery International Cooperation Study (BASICS): a prospective registry study. Lancet Neurol. 2009 Aug;8(8):724-30. doi: 10.1016/S1474-4422(09)70173-5. Epub 2009 Jul 3.
PMID: 19577962
citation: Greving JP, Schonewille WJ, Wijman CA, Michel P, Kappelle LJ, Algra A; BASICS Study Group. Predicting outcome after acute basilar artery occlusion based on admission characteristics. Neurology. 2012 Apr 3;78(14):1058-63. doi: 10.1212/WNL.0b013e31824e8f40. Epub 2012 Mar 21.
PMID: 22442438
citation: Vergouwen MD, Compter A, Tanne D, Engelter ST, Audebert H, Thijs V, de Freitas G, Algra A, Jaap Kappelle L, Schonewille WJ. Outcomes of basilar artery occlusion in patients aged 75 years or older in the Basilar Artery International Cooperation Study. J Neurol. 2012 Nov;259(11):2341-6. doi: 10.1007/s00415-012-6498-2. Epub 2012 Apr 18.
PMID: 22527236
citation: Puetz V, Khomenko A, Hill MD, Dzialowski I, Michel P, Weimar C, Wijman CA, Mattle HP, Engelter ST, Muir KW, Pfefferkorn T, Tanne D, Szabo K, Kappelle LJ, Algra A, von Kummer R, Demchuk AM, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Group. Extent of hypoattenuation on CT angiography source images in basilar artery occlusion: prognostic value in the Basilar Artery International Cooperation Study. Stroke. 2011 Dec;42(12):3454-9. doi: 10.1161/STROKEAHA.111.622175. Epub 2011 Sep 29.
PMID: 21960577
citation: Arnold M, Fischer U, Compter A, Gralla J, Findling O, Mattle HP, Kappelle LJ, Tanne D, Algra A, Schonewille WJ; BASICS Study Group. Acute basilar artery occlusion in the Basilar Artery International Cooperation Study: does gender matter? Stroke. 2010 Nov;41(11):2693-6. doi: 10.1161/STROKEAHA.110.594036. Epub 2010 Oct 14.
PMID: 20947845
citation: Schonewille WJ, Wijman CA, Michel P, Algra A, Kappelle LJ; BASICS Study Group. The basilar artery international cooperation study (BASICS). Int J Stroke. 2007 Aug;2(3):220-3. doi: 10.1111/j.1747-4949.2007.00145.x.
PMID: 18705948
citation: Schonewille W, Wijman C, Michel P; BASICS investigators. Treatment and clinical outcome in patients with basilar artery occlusion. Stroke. 2006 Sep;37(9):2206; author reply 2207. doi: 10.1161/01.STR.0000237127.84408.c0. Epub 2006 Aug 10. No abstract available.
PMID: 16902170
citation: Vergouwen MD, Algra A, Pfefferkorn T, Weimar C, Rueckert CM, Thijs V, Kappelle LJ, Schonewille WJ; Basilar Artery International Cooperation Study (BASICS) Study Group. Time is brain(stem) in basilar artery occlusion. Stroke. 2012 Nov;43(11):3003-6. doi: 10.1161/STROKEAHA.112.666867. Epub 2012 Sep 18.
PMID: 22989501
responsible party type: Sponsor-Investigator
investigator affiliation: St. Antonius Hospital
investigator full name: Erik van der Hoeven
investigator title: E.J.R.J. van der Hoeven, MD
mesh term: Stroke
mesh term: Cerebrovascular Disorders
mesh term: Thrombosis
mesh term: Embolism