<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/NCT03252314</url>
  </required_header>
  <id_info>
    <org_study_id>RAGE</org_study_id>
    <nct_id>NCT03252314</nct_id>
  </id_info>
  <brief_title>Ruptured Aneurysms Treated With Hydrogel Coils</brief_title>
  <acronym>RAGE</acronym>
  <official_title>Ruptured Aneurysms Treated With Hydrogel Coils</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Microvention-Terumo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Semmes-Murphey Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Microvention-Terumo, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine safety and occlusion rates when second-generation hydrogel coils are used in the&#xD;
      treatment of ruptured intracranial aneurysms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RAGE is a prospective, non-randomized, multicenter, post-market study. The RAGE study is&#xD;
      designed to determine the safety and occlusion rates of hydrogel coils in the ruptured&#xD;
      aneurysm study population. Secondary objectives include determining clinical outcomes,&#xD;
      packing density, occlusion stability, rates of recurrence, rebleed, retreatment, and adverse&#xD;
      events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Death or major stroke</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Major ipsilateral stroke, neurological death, or rebleeding from the target aneurysm</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rebleed rate of the target aneurysm</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rebleed rate of the target aneurysm</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Score (mRS)</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Score (mRS)</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Packing density measured by volumetric filling of the aneurysm</measure>
    <time_frame>Immediately following procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retreatment rate</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retreatment rate due to recurrence</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm or retreatment for residual aneurysm</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occlusion Stability (as defined by the Raymond Roy Occlusion Classification)</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events related to the device and/or the procedure</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Ruptured Aneurysm</condition>
  <arm_group>
    <arm_group_label>Subjects with ruptured aneurysms</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Second-generation hydrogel coils</intervention_name>
    <description>Hydrogel coils 90% by length</description>
    <arm_group_label>Subjects with ruptured aneurysms</arm_group_label>
    <other_name>HydroFrame</other_name>
    <other_name>HydroFill</other_name>
    <other_name>HydroSoft</other_name>
    <other_name>HydroSoft 3D</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 18 - 80 years with a ruptured saccular intracranial aneurysm in whom coil&#xD;
        embolization is determined to be the appropriate treatment strategy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is ≥ 18 and ≤ 80 years of age.&#xD;
&#xD;
          2. Patient has a previously untreated, ruptured saccular intracranial aneurysm 2 - 15 mm&#xD;
             in diameter for which the clinical decision to treat with hydrogel coil embolization&#xD;
             has been made independent of the decision to participate in the study described in&#xD;
             this protocol.&#xD;
&#xD;
          3. Patient has a baseline Hunt and Hess Score of I, II, or III.&#xD;
&#xD;
          4. Patient or patient's legally authorized representative has provided written informed&#xD;
             consent.&#xD;
&#xD;
          5. Patient must be considered by the treating physician to be available for and able to&#xD;
             complete all followup visits.&#xD;
&#xD;
          6. Patient has not been previously entered into this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to obtain written informed consent.&#xD;
&#xD;
          2. Patient is &lt; 18 or &gt; 80 years of age.&#xD;
&#xD;
          3. Patient has a baseline Hunt and Hess score of IV or V.&#xD;
&#xD;
          4. Target aneurysm is dissecting, fusiform, mycotic, blister-like, tumoral, or&#xD;
             AVM-related.&#xD;
&#xD;
          5. Target aneurysm maximum diameter is &gt; 15 mm or &lt; 2 mm.&#xD;
&#xD;
          6. Target aneurysm was previously treated via clipping or coiling.&#xD;
&#xD;
          7. Target aneurysm is deemed by the treating physician to be unsuitable for coiling or&#xD;
             unlikely to be successfully treated by endovascular techniques.&#xD;
&#xD;
          8. Target aneurysm has not been confidently determined by the treating physician to be&#xD;
             the source of SAH.&#xD;
&#xD;
          9. Planned use of a flow diverter or intrasaccular device as a component of the target&#xD;
             aneurysm treatment plan.&#xD;
&#xD;
         10. Intended use of a coil-assist stent as a component of the target aneurysm treatment&#xD;
             plan, unless use of a stent is 1) planned as a subsequent stage of a staged coiling&#xD;
             procedure or 2) used for bailout purposes.&#xD;
&#xD;
         11. Patient has a known, untreatable hypersensitivity to contrast dye, iodine, hydrogel,&#xD;
             or any other component of the treatment device.&#xD;
&#xD;
         12. Patient has a contraindication to heparin or aspirin.&#xD;
&#xD;
         13. Patient has vascular anatomy/tortuosity preventing access to the target aneurysm.&#xD;
&#xD;
         14. Patient is unable to undergo DSA or DSA is determined unsuitable or outside standard&#xD;
             of care by the treating physician.&#xD;
&#xD;
         15. Patient has a serious or life-threatening comorbidity that could confound study&#xD;
             results.&#xD;
&#xD;
         16. Patient is at high risk of noncompliance due to a history of substance abuse,&#xD;
             psychosocial issues, etc.&#xD;
&#xD;
         17. Patient is unable to complete scheduled followup assessments due to comorbidities,&#xD;
             geographical limitations, or a life expectancy of less than 18 months.&#xD;
&#xD;
         18. Patient is pregnant, breastfeeding, or plans to become pregnant prior to completion of&#xD;
             followup.&#xD;
&#xD;
         19. Patient is enrolled in another device or drug study in which participation could&#xD;
             confound study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam S Arthur, MD, MPH, FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Semmes-Murphey Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Fiorella, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stony Brook Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kellee Rivera, Semmes Murphey Foundation</last_name>
    <phone>901-260-6111</phone>
    <email>krrivera@semmes-murphey.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Methodist University Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amanda Nolte</last_name>
      <phone>901-259-5316</phone>
      <email>annolte@semmes-murphey.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>March 8, 2022</last_update_submitted>
  <last_update_submitted_qc>March 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aneurysm, Ruptured</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/NCT03252314
org study id: RAGE
nct id: NCT03252314
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
To determine safety and occlusion rates when second-generation hydrogel coils are used in the
      treatment of ruptured intracranial aneurysms.
RAGE is a prospective, non-randomized, multicenter, post-market study. The RAGE study is
      designed to determine the safety and occlusion rates of hydrogel coils in the ruptured
      aneurysm study population. Secondary objectives include determining clinical outcomes,
      packing density, occlusion stability, rates of recurrence, rebleed, retreatment, and adverse
      events.
observational model: Cohort
time perspective: Prospective
measure: Death or major stroke
time frame: 30 days
measure: Major ipsilateral stroke, neurological death, or rebleeding from the target aneurysm
time frame: 18 months
measure: Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without interim retreatment secondary to aneurysm recurrence or rebleed of the target aneurysm
time frame: 18 months
measure: Rebleed rate of the target aneurysm
time frame: 30 days
measure: Rebleed rate of the target aneurysm
time frame: 18 months
measure: Modified Rankin Score (mRS)
time frame: 18 months
measure: Modified Rankin Score (mRS)
time frame: 30 days
measure: Packing density measured by volumetric filling of the aneurysm
time frame: Immediately following procedure
measure: Retreatment rate
time frame: 18 months
measure: Retreatment rate due to recurrence
time frame: 18 months
measure: Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm
time frame: 18 months
measure: Adequate angiographic occlusion (as defined by the Raymond Roy Occlusion Classification) without rebleed of the target aneurysm or retreatment for residual aneurysm
time frame: 18 months
measure: Occlusion Stability (as defined by the Raymond Roy Occlusion Classification)
time frame: 18 months
measure: Adverse events related to the device and/or the procedure
time frame: 18 months
arm group label: Subjects with ruptured aneurysms
intervention type: Device
intervention name: Second-generation hydrogel coils
description: Hydrogel coils 90% by length
arm group label: Subjects with ruptured aneurysms
other name: HydroFrame
other name: HydroFill
other name: HydroSoft
other name: HydroSoft 3D
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Adam S Arthur, MD, MPH, FACS
role: Principal Investigator
affiliation: Semmes-Murphey Clinic
last name: David Fiorella, MD, PhD
role: Principal Investigator
affiliation: Stony Brook Medical Center
last name: Kellee Rivera, Semmes Murphey Foundation
phone: 901-260-6111
email: krrivera@semmes-murphey.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aneurysm, Ruptured
sharing ipd: Undecided