<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/NCT03273478</url>
  </required_header>
  <id_info>
    <org_study_id>PTW2/PH/20170823</org_study_id>
    <nct_id>NCT03273478</nct_id>
  </id_info>
  <brief_title>pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2</brief_title>
  <acronym>pToWin2</acronym>
  <official_title>pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Phenox GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Phenox GmbH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation&#xD;
      aneurysms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Title: pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2&#xD;
&#xD;
      Acronym: pToWin2&#xD;
&#xD;
      Device: pCONUS2 Bifurcation Aneurysm Implant&#xD;
&#xD;
      Study design: Prospective, multicenter, single-arm clinical investigation&#xD;
&#xD;
      Purpose: To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation&#xD;
      aneurysms&#xD;
&#xD;
      Duration of the study: 30 months&#xD;
&#xD;
      Sample size: 100 evaluable patients&#xD;
&#xD;
      Number of sites: max. 15&#xD;
&#xD;
      Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site&#xD;
      specific standard&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Effectiveness: Aneurysm occlusion (complete or neck remnant)</measure>
    <time_frame>Change from post-procedure to 12 months</time_frame>
    <description>Assessment by Raymond-Roy occlusion scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm</measure>
    <time_frame>within 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: The &quot;Effectiveness endpoint&quot; is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>- To place pCONUS2 in the desired location</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: The &quot;Effectiveness endpoint&quot; is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>- Correct opening of the device (crown and shaft)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: The &quot;Effectiveness endpoint&quot; is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>- To perform aneurysm occlusion without obliteration of side branches</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effectiveness: The &quot;Effectiveness endpoint&quot; is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>- To detach the device at the end of the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Intra-Procedural Complications The &quot;Safety Intra-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>- Vessel perforation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Intra-Procedural Complications The &quot;Safety Intra-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>- Target aneurysm perforation with microcatheter or guidewire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Intra-Procedural Complications The &quot;Safety Intra-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>- Target aneurysm perforation with pCONUS2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Intra-Procedural Complications The &quot;Safety Intra-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>- Target aneurysm perforation with coils</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Intra-Procedural Complications The &quot;Safety Intra-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>- Thromboembolism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Intra-Procedural Complications The &quot;Safety Intra-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>at the time of the procedure</time_frame>
    <description>- Dissection of any access vessel</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Post-Procedural Complications The &quot;Safety Post-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>Change 1day post procedure up to 12months</time_frame>
    <description>- Frequency of new parenchymal hemorrhage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Post-Procedural Complications The &quot;Safety Post-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>Change 1day post procedure up to 12months</time_frame>
    <description>- Frequency of new subarachnoid hemorrhage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Post-Procedural Complications The &quot;Safety Post-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>Change 1day post procedure up to 12months</time_frame>
    <description>- Frequency of new ischemic stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Post-Procedural Complications The &quot;Safety Post-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>Change 1day post procedure up to 12months</time_frame>
    <description>- Rupture of the target aneurysm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Post-Procedural Complications The &quot;Safety Post-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>Change 1day post procedure up to 12months</time_frame>
    <description>- Rate of in-stent-stenosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Post-Procedural Complications The &quot;Safety Post-Procedural Complications&quot; endpoint is assessed throughout the intervention and is assessed as &quot;number/amount of&quot;:</measure>
    <time_frame>Change 1day post procedure up to 12months</time_frame>
    <description>- Rate of in-stent-thrombosis</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Intracranial Aneurysm</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endovascular treatment of bifurcation aneurysm with pCONUS2</intervention_name>
    <description>Patients suffering from a bifurcation aneurysm will be treated endovascularly with the pCONUS2 device.&#xD;
The patients do not face any additional risks by participating in the study as the treatment does not differ from the standard of care in any way.&#xD;
The patients will only be enrolled in the study if they give their written consent.&#xD;
If they do not wish to participate in the observational study or if they wish to withdraw from it at a later date, they will not have any disadvantages.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients harbouring an unruptured or ruptured bifurcation aneurysm, in which&#xD;
        pCONUS2-assisted coiling was judged to be the most appropriate treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aneurysm status:&#xD;
&#xD;
               -  Unruptured aneurysm or&#xD;
&#xD;
               -  Ruptured aneurysm with a Hunt and Hess grade of I - III.&#xD;
&#xD;
          2. Age ≥18.&#xD;
&#xD;
          3. The patient or legal representative provides written informed consent.&#xD;
&#xD;
          4. The patient shows general compliance to follow the medical regimen and to attend&#xD;
             follow-up examinations.&#xD;
&#xD;
          5. The target aneurysm is located at one of the following cerebral vessel bifurcations:&#xD;
             ICA terminus, AcomA, MCA or BA.&#xD;
&#xD;
          6. Bifurcation wide neck aneurysm.&#xD;
&#xD;
          7. The dome height should allow for safe deployment of the device crown. The fundus of&#xD;
             the aneurysm should offer enough space for the crown of the pCONUS2 to deploy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Vessel tortuosity precluding safe access and device deployment.&#xD;
&#xD;
          2. Stenosis within the vascular access or target vessel ≥ 50 %.&#xD;
&#xD;
          3. The target aneurysm has been previously treated with a stent or an intraaneurysmal&#xD;
             implant beside coils.&#xD;
&#xD;
          4. The treatment plan for the target aneurysm includes the use of additional intra-&#xD;
             and/or extraaneurysmal temporary or permanent implants other than coils.&#xD;
&#xD;
          5. More than one intracerebral aneurysm requires the treatment within the following 6&#xD;
             months.&#xD;
&#xD;
          6. Imaging evidence of an arteriovenous cerebrovascular malformation or a dural fistula.&#xD;
&#xD;
          7. Any physical, medical or psychiatric condition of the patient interfering with the&#xD;
             adherence of the requirements and follow-up regimen of the study.&#xD;
&#xD;
          8. Any neurological disorder with progressive neurological symptoms, except attributable&#xD;
             to a compressive effect of the target aneurysm.&#xD;
&#xD;
          9. Current involvement in another study or trial.&#xD;
&#xD;
         10. Women of child bearing potential or breast-feeding who cannot provide a negative&#xD;
             pregnancy test.&#xD;
&#xD;
         11. Known allergy to the components of device, study medication or contrast media that&#xD;
             cannot be controlled medically.&#xD;
&#xD;
         12. A medical condition interfering with a dual antiplatelet treatment.&#xD;
&#xD;
         13. Known coagulopathy.&#xD;
&#xD;
         14. Intracranial hemorrhage in the past 30 days apart from the target aneurysm.&#xD;
&#xD;
         15. Ischemic stroke in the past 30 days.&#xD;
&#xD;
         16. Myocardial infarction in the past 30 days.&#xD;
&#xD;
         17. Major surgery in the past 30 days.&#xD;
&#xD;
         18. Evidence of active infection at time of treatment.&#xD;
&#xD;
         19. Co -morbidities or conditions with a life expectancy less than 12 months.&#xD;
&#xD;
         20. Additional Exclusion criteria for ruptured aneurysm at the acute phase:&#xD;
&#xD;
               1. The patient is clinically severely affected (Hunt and Hess grade IV and V).&#xD;
&#xD;
               2. Severe vasospasm is proven during angiography.&#xD;
&#xD;
               3. Proven parenchymal hemorrhage by CT or MRI.&#xD;
&#xD;
               4. Proven subdural hematoma by CT or MRI.&#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_contact>
    <last_name>Konopka</last_name>
    <phone>+49 0234 36919</phone>
    <phone_ext>0</phone_ext>
    <email>pToWin2@phenox.info</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Treffner, Dr.</last_name>
    <phone>+49 0234 36919</phone>
    <phone_ext>0</phone_ext>
    <email>pToWin2@phenox.info</email>
  </overall_contact_backup>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bifurcation aneurysm</keyword>
  <keyword>Unruptured bifurcation aneurysm</keyword>
  <keyword>Ruptured bifurcation aneurysm</keyword>
  <keyword>Stent-assisted coiling</keyword>
  <keyword>pCONUS2 Bifurcation Aneurysm Implant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</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/NCT03273478
org study id: PTW2/PH/20170823
nct id: NCT03273478
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation
      aneurysms.
Title: pCONUS2 Treatment of Wide Neck Intracranial Aneurysms 2

      Acronym: pToWin2

      Device: pCONUS2 Bifurcation Aneurysm Implant

      Study design: Prospective, multicenter, single-arm clinical investigation

      Purpose: To assess safety and efficacy of pCONUS2 for the treatment of wide neck bifurcation
      aneurysms

      Duration of the study: 30 months

      Sample size: 100 evaluable patients

      Number of sites: max. 15

      Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site
      specific standard
observational model: Cohort
time perspective: Prospective
measure: Effectiveness: Aneurysm occlusion (complete or neck remnant)
time frame: Change from post-procedure to 12 months
description: Assessment by Raymond-Roy occlusion scale
measure: Safety: Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
time frame: within 12 months
measure: Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
time frame: at the time of the procedure
description: - To place pCONUS2 in the desired location
measure: Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
time frame: at the time of the procedure
description: - Correct opening of the device (crown and shaft)
measure: Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
time frame: at the time of the procedure
description: - To perform aneurysm occlusion without obliteration of side branches
measure: Effectiveness: The "Effectiveness endpoint" is assessed throughout the intervention and is assessed as "number/amount of":
time frame: at the time of the procedure
description: - To detach the device at the end of the procedure
measure: Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: at the time of the procedure
description: - Vessel perforation
measure: Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: at the time of the procedure
description: - Target aneurysm perforation with microcatheter or guidewire
measure: Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: at the time of the procedure
description: - Target aneurysm perforation with pCONUS2
measure: Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: at the time of the procedure
description: - Target aneurysm perforation with coils
measure: Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: at the time of the procedure
description: - Thromboembolism
measure: Safety Intra-Procedural Complications The "Safety Intra-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: at the time of the procedure
description: - Dissection of any access vessel
measure: Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: Change 1day post procedure up to 12months
description: - Frequency of new parenchymal hemorrhage
measure: Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: Change 1day post procedure up to 12months
description: - Frequency of new subarachnoid hemorrhage
measure: Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: Change 1day post procedure up to 12months
description: - Frequency of new ischemic stroke
measure: Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: Change 1day post procedure up to 12months
description: - Rupture of the target aneurysm
measure: Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: Change 1day post procedure up to 12months
description: - Rate of in-stent-stenosis
measure: Safety Post-Procedural Complications The "Safety Post-Procedural Complications" endpoint is assessed throughout the intervention and is assessed as "number/amount of":
time frame: Change 1day post procedure up to 12months
description: - Rate of in-stent-thrombosis
intervention type: Device
intervention name: Endovascular treatment of bifurcation aneurysm with pCONUS2
description: Patients suffering from a bifurcation aneurysm will be treated endovascularly with the pCONUS2 device.
The patients do not face any additional risks by participating in the study as the treatment does not differ from the standard of care in any way.
The patients will only be enrolled in the study if they give their written consent.
If they do not wish to participate in the observational study or if they wish to withdraw from it at a later date, they will not have any disadvantages.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Konopka
phone: +49 0234 36919
phone ext: 0
email: pToWin2@phenox.info
last name: Treffner, Dr.
phone: +49 0234 36919
phone ext: 0
email: pToWin2@phenox.info
responsible party type: Sponsor
mesh term: Intracranial Aneurysm
mesh term: Aneurysm