<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/NCT01668563</url>
  </required_header>
  <id_info>
    <org_study_id>CE 12.136</org_study_id>
    <nct_id>NCT01668563</nct_id>
  </id_info>
  <brief_title>International Subarachnoid Aneurysm Trial II</brief_title>
  <acronym>ISAT II</acronym>
  <official_title>International Subarachnoid Aneurysm Trial II Comparing Clinical Outcomes of Surgical Clipping and Endovascular Coiling for Ruptured Intracranial Aneurysms Not Included in the Original ISAT Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the clinical outcome of surgical clipping and&#xD;
      endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT&#xD;
      Study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The International Subarachnoid Aneurysm Trial (ISAT) was a turning point in modern&#xD;
      neurosurgical history (1). The trial showed that for 2143 subarachnoid hemorrhage&#xD;
      (SAH)patients eligible for both surgery and endovascular coiling, randomized allocation to&#xD;
      coiling was associated with better one year clinical outcomes, defined as survival without&#xD;
      dependency (absolute risk reduction (ARR) of 7.4% (95%CI; 3.6 - 11.2, p=0.0001). Because ISAT&#xD;
      was a positive pragmatic trial, the interpretation of the trial results was that coiling&#xD;
      should be adopted as the first-line treatment for ruptured lesions, for patients with the&#xD;
      types of aneurysms included in ISAT, of which the great majority were small (≥10 mm) anterior&#xD;
      circulation aneurysms.&#xD;
&#xD;
      Although ISAT was well-designed, conducted, and reported, trial results were not always&#xD;
      properly interpreted, and endovascular coiling was perhaps inappropriately extrapolated&#xD;
      beyond what ISAT demonstrated. Endovascular treatment for ruptured aneurysms has now become&#xD;
      first-line treatment in many centers (2), which may be appropriate for small, anterior&#xD;
      circulation lesions, but there is no evidence to support this practice for the wide spectrum&#xD;
      of non-ISAT patients and aneurysms. A recent pre-randomized study of coiling as&#xD;
      first-intention (3)showed better results for those ruptured aneurysms felt to be readily&#xD;
      coilable; however, the optimal management of more difficult-to-coil ruptured aneurysms&#xD;
      remains unclear.&#xD;
&#xD;
      Further compounding the problem are the concerns that aneurysm coiling may not be as durable&#xD;
      in the long-term as surgical clipping, leading many neurosurgeons to continue to clip most&#xD;
      ruptured aneurysms in spite of ISAT results.&#xD;
&#xD;
      Proponents of endovascular treatment sometimes justify this extrapolation of ISAT results on&#xD;
      the basis of improved catheter and coil technology, although this has never been&#xD;
      demonstrated. However, the addition of stents and flow-diverters, which were not tested in&#xD;
      ISAT, may increase endovascular treatment risks, especially when combined with dual&#xD;
      anti-platelet agents. The introduction of these devices allowed for the expansion of&#xD;
      indications of EVT to include wide-necked aneurysms, lesions which would not have been&#xD;
      included in ISAT. The wider spectrum of patients and aneurysms now considered for EVT may not&#xD;
      all experience the same degree of benefit as seen in the original ISAT trial (4). Considering&#xD;
      the relatively small ARR of 7.4% favouring coiling, when the additional risks due to stents&#xD;
      are included, the balance may have tipped to favour surgical clipping.&#xD;
&#xD;
      These new questions deserve formal study in the context of a randomized clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 12, 2012</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>poor clinical outcome(mRS&gt;2)</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients experiencing a poor clinical outcome at one year post-treatment, defined as a modified Rankin Scale (mRS) score of &gt;2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of an intracranial hemorrhage following treatment</measure>
    <time_frame>one year</time_frame>
    <description>An intracranial hemorrhage will be judged from cross-sectional imaging (CT or MRI), from a positive lumbar puncture in the setting of an acute headache, or following sudden death preceded by an acute headache.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Failure of aneurysm occlusion using the intended treatment modality</measure>
    <time_frame>within 48 hours after attempted treatment</time_frame>
    <description>In situations where treatment is initiated but terminated without a proper test of that treatment modality, such as in the event of anaesthetic difficulty requiring the intended treatment to be delayed, will not count as a failure. However, patients left with clinically concerning aneurysm residuals (in the opinion of the treating physician) after the treatment attempt will count as a failure of the initial treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall mortality and morbidity</measure>
    <time_frame>one year and five years</time_frame>
    <description>Mortality and morbidity from all causes will be recorded, along with cause of death, at one and five years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of a &quot;major&quot; (saccular) aneurysm recurrence</measure>
    <time_frame>12 months (+/- 2 months)</time_frame>
    <description>Determined using non-invasive angiography (CTA or MRA)as part of normal follow-up after aneurysm treatment. Although DSA, CTA and MRA are known to have different sensitivities in detecting aneurysm remnants,these modalities are equally well-suited to the discovery of a concerning, saccular aneurysm residual or remnant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-treatment hospitalization lasting more than 20 days and/or discharge to a location other than home</measure>
    <time_frame>within a month or at discharge if earlier</time_frame>
    <description>Will be recorded by the local treating physician upon discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of aneurysm re-rupture following randomization but before treatment initiation</measure>
    <time_frame>Within a few hours (while awaiting treatment)</time_frame>
    <description>Repeat intracranial hemorrhage will be judged from cross-sectional imaging (CT scan), after worsening of headache, or following a new-onset neurological deficit or sudden death while awaiting treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1724</enrollment>
  <condition>Intracranial Hemorrhage Ruptured Aneurysm</condition>
  <arm_group>
    <arm_group_label>Endovascular management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endovascular treatment will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgical management</intervention_name>
    <description>Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.</description>
    <arm_group_label>Surgical management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endovascular management</intervention_name>
    <description>Endovascular treatment will also be performed as soon as possible following randomization,according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.</description>
    <arm_group_label>Endovascular management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at least 18 years of age&#xD;
&#xD;
          -  At least one documented, intradural, intracranial aneurysm, ruptured within last 30&#xD;
             days&#xD;
&#xD;
          -  SAH WFNS grade 4 or less&#xD;
&#xD;
          -  The patient and aneurysm are considered appropriate for either surgical or&#xD;
             endovascular treatment by the treating team&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with absolute contraindications administration of contrast material (any&#xD;
             type)&#xD;
&#xD;
          -  Patients with AVM-associated aneurysms&#xD;
&#xD;
          -  Aneurysm located at basilar apex&#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>Tim Darsaut, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Max Findlay, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roland Jabre, MD</last_name>
    <phone>514-890-8000</phone>
    <phone_ext>27235</phone_ext>
    <email>roland.jabre.med@ssss.gouv.qc.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Guylaine Gevry</last_name>
    <phone>514-890-8000</phone>
    <phone_ext>27235</phone_ext>
    <email>guylaine.gevry.chum@ssss.gouv.qc.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David J Altschul, MD</last_name>
      <phone>718-920-7498</phone>
      <email>DALTSCHU@montefiore.org</email>
    </contact>
    <investigator>
      <last_name>David J Altschul, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Foothills Medical Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tim Darsaut, MD, MSc</last_name>
      <email>tdarsaut@ualberta.ca</email>
    </contact>
    <investigator>
      <last_name>Tim Darsaut, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0C1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guylaine Gevry</last_name>
      <phone>1-514-890-8000</phone>
      <phone_ext>27235</phone_ext>
      <email>guylaine.gevry.chum@ssss.gouv.qc.ca</email>
    </contact>
    <investigator>
      <last_name>Jean Raymond, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel Roy, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alain Weill, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michel Bojanowski, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chiraz Chaalala, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vall d'Hebron Hospital</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jordi Vilalta, MD</last_name>
      <phone>93 489 38 91</phone>
      <email>pelagatosiv@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Valladolid</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Herrero Rosario Sarabia, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ignacio Arrese Reganon, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Molyneux A, Kerr R, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet. 2002 Oct 26;360(9342):1267-74. doi: 10.1016/s0140-6736(02)11314-6.</citation>
    <PMID>12414200</PMID>
  </reference>
  <reference>
    <citation>Gnanalingham KK, Apostolopoulos V, Barazi S, O'Neill K. The impact of the international subarachnoid aneurysm trial (ISAT) on the management of aneurysmal subarachnoid haemorrhage in a neurosurgical unit in the UK. Clin Neurol Neurosurg. 2006 Feb;108(2):117-23. doi: 10.1016/j.clineuro.2005.11.001. Epub 2005 Dec 20.</citation>
    <PMID>16364540</PMID>
  </reference>
  <reference>
    <citation>McDougall CG, Spetzler RF, Zabramski JM, Partovi S, Hills NK, Nakaji P, Albuquerque FC. The Barrow Ruptured Aneurysm Trial. J Neurosurg. 2012 Jan;116(1):135-44. doi: 10.3171/2011.8.JNS101767. Epub 2011 Nov 4.</citation>
    <PMID>22054213</PMID>
  </reference>
  <reference>
    <citation>Raymond J, Kotowski M, Darsaut TE, Molyneux AJ, Kerr RS. Ruptured aneurysms and the International Subarachnoid Aneurysm Trial (ISAT): What is known and what remains to be questioned. Neurochirurgie. 2012 Apr-Jun;58(2-3):103-14. doi: 10.1016/j.neuchi.2012.02.020. Epub 2012 Apr 4. English, French.</citation>
    <PMID>22481029</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>July 4, 2023</last_update_submitted>
  <last_update_submitted_qc>July 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aneurysm</keyword>
  <keyword>Intracranial Aneurysm</keyword>
  <keyword>Vascular Diseases</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <keyword>Intracranial Arterial Diseases</keyword>
  <keyword>Cerebrovascular Disorders</keyword>
  <keyword>Brain Diseases</keyword>
  <keyword>Central Nervous System Diseases</keyword>
  <keyword>Nervous System Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Intracranial Hemorrhages</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aneurysm, Ruptured</mesh_term>
    <mesh_term>Hemorrhage</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/NCT01668563
org study id: CE 12.136
nct id: NCT01668563
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the clinical outcome of surgical clipping and
      endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT
      Study.
The International Subarachnoid Aneurysm Trial (ISAT) was a turning point in modern
      neurosurgical history (1). The trial showed that for 2143 subarachnoid hemorrhage
      (SAH)patients eligible for both surgery and endovascular coiling, randomized allocation to
      coiling was associated with better one year clinical outcomes, defined as survival without
      dependency (absolute risk reduction (ARR) of 7.4% (95%CI; 3.6 - 11.2, p=0.0001). Because ISAT
      was a positive pragmatic trial, the interpretation of the trial results was that coiling
      should be adopted as the first-line treatment for ruptured lesions, for patients with the
      types of aneurysms included in ISAT, of which the great majority were small (≥10 mm) anterior
      circulation aneurysms.

      Although ISAT was well-designed, conducted, and reported, trial results were not always
      properly interpreted, and endovascular coiling was perhaps inappropriately extrapolated
      beyond what ISAT demonstrated. Endovascular treatment for ruptured aneurysms has now become
      first-line treatment in many centers (2), which may be appropriate for small, anterior
      circulation lesions, but there is no evidence to support this practice for the wide spectrum
      of non-ISAT patients and aneurysms. A recent pre-randomized study of coiling as
      first-intention (3)showed better results for those ruptured aneurysms felt to be readily
      coilable; however, the optimal management of more difficult-to-coil ruptured aneurysms
      remains unclear.

      Further compounding the problem are the concerns that aneurysm coiling may not be as durable
      in the long-term as surgical clipping, leading many neurosurgeons to continue to clip most
      ruptured aneurysms in spite of ISAT results.

      Proponents of endovascular treatment sometimes justify this extrapolation of ISAT results on
      the basis of improved catheter and coil technology, although this has never been
      demonstrated. However, the addition of stents and flow-diverters, which were not tested in
      ISAT, may increase endovascular treatment risks, especially when combined with dual
      anti-platelet agents. The introduction of these devices allowed for the expansion of
      indications of EVT to include wide-necked aneurysms, lesions which would not have been
      included in ISAT. The wider spectrum of patients and aneurysms now considered for EVT may not
      all experience the same degree of benefit as seen in the original ISAT trial (4). Considering
      the relatively small ARR of 7.4% favouring coiling, when the additional risks due to stents
      are included, the balance may have tipped to favour surgical clipping.

      These new questions deserve formal study in the context of a randomized clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: poor clinical outcome(mRS>2)
time frame: 12 months
description: Number of patients experiencing a poor clinical outcome at one year post-treatment, defined as a modified Rankin Scale (mRS) score of >2.
measure: Occurrence of an intracranial hemorrhage following treatment
time frame: one year
description: An intracranial hemorrhage will be judged from cross-sectional imaging (CT or MRI), from a positive lumbar puncture in the setting of an acute headache, or following sudden death preceded by an acute headache.
measure: Failure of aneurysm occlusion using the intended treatment modality
time frame: within 48 hours after attempted treatment
description: In situations where treatment is initiated but terminated without a proper test of that treatment modality, such as in the event of anaesthetic difficulty requiring the intended treatment to be delayed, will not count as a failure. However, patients left with clinically concerning aneurysm residuals (in the opinion of the treating physician) after the treatment attempt will count as a failure of the initial treatment.
measure: Overall mortality and morbidity
time frame: one year and five years
description: Mortality and morbidity from all causes will be recorded, along with cause of death, at one and five years.
measure: Occurence of a "major" (saccular) aneurysm recurrence
time frame: 12 months (+/- 2 months)
description: Determined using non-invasive angiography (CTA or MRA)as part of normal follow-up after aneurysm treatment. Although DSA, CTA and MRA are known to have different sensitivities in detecting aneurysm remnants,these modalities are equally well-suited to the discovery of a concerning, saccular aneurysm residual or remnant.
measure: Peri-treatment hospitalization lasting more than 20 days and/or discharge to a location other than home
time frame: within a month or at discharge if earlier
description: Will be recorded by the local treating physician upon discharge.
measure: Occurence of aneurysm re-rupture following randomization but before treatment initiation
time frame: Within a few hours (while awaiting treatment)
description: Repeat intracranial hemorrhage will be judged from cross-sectional imaging (CT scan), after worsening of headache, or following a new-onset neurological deficit or sudden death while awaiting treatment.
arm group label: Endovascular management
arm group type: Active Comparator
description: Endovascular treatment will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.
arm group label: Surgical management
arm group type: Active Comparator
description: Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.
intervention type: Procedure
intervention name: surgical management
description: Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.
arm group label: Surgical management
intervention type: Procedure
intervention name: Endovascular management
description: Endovascular treatment will also be performed as soon as possible following randomization,according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.
arm group label: Endovascular management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tim Darsaut, MD
role: Principal Investigator
affiliation: University of Alberta
last name: Max Findlay, MD
role: Principal Investigator
affiliation: University of Alberta
last name: Roland Jabre, MD
phone: 514-890-8000
phone ext: 27235
email: roland.jabre.med@ssss.gouv.qc.ca
last name: Guylaine Gevry
phone: 514-890-8000
phone ext: 27235
email: guylaine.gevry.chum@ssss.gouv.qc.ca
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
investigator: 
investigator: 
country: Canada
country: Spain
country: United States
citation: Molyneux A, Kerr R, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet. 2002 Oct 26;360(9342):1267-74. doi: 10.1016/s0140-6736(02)11314-6.
PMID: 12414200
citation: Gnanalingham KK, Apostolopoulos V, Barazi S, O'Neill K. The impact of the international subarachnoid aneurysm trial (ISAT) on the management of aneurysmal subarachnoid haemorrhage in a neurosurgical unit in the UK. Clin Neurol Neurosurg. 2006 Feb;108(2):117-23. doi: 10.1016/j.clineuro.2005.11.001. Epub 2005 Dec 20.
PMID: 16364540
citation: McDougall CG, Spetzler RF, Zabramski JM, Partovi S, Hills NK, Nakaji P, Albuquerque FC. The Barrow Ruptured Aneurysm Trial. J Neurosurg. 2012 Jan;116(1):135-44. doi: 10.3171/2011.8.JNS101767. Epub 2011 Nov 4.
PMID: 22054213
citation: Raymond J, Kotowski M, Darsaut TE, Molyneux AJ, Kerr RS. Ruptured aneurysms and the International Subarachnoid Aneurysm Trial (ISAT): What is known and what remains to be questioned. Neurochirurgie. 2012 Apr-Jun;58(2-3):103-14. doi: 10.1016/j.neuchi.2012.02.020. Epub 2012 Apr 4. English, French.
PMID: 22481029
responsible party type: Sponsor
mesh term: Intracranial Aneurysm
mesh term: Intracranial Hemorrhages
mesh term: Aneurysm
mesh term: Aneurysm, Ruptured
mesh term: Hemorrhage