<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/NCT02988128</url>
  </required_header>
  <id_info>
    <org_study_id>MDT16056/MDT17077</org_study_id>
    <nct_id>NCT02988128</nct_id>
  </id_info>
  <brief_title>Neurovascular Product Surveillance Registry</brief_title>
  <acronym>INSPIRE</acronym>
  <official_title>NeuroVascular Product Surveillance Registry (PSR) Platform</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Neurovascular Clinical Affairs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic Bakken Research Center</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Medtronic Neurovascular Clinical Affairs</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post market surveillance registry&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An observational, prospective, multi-center, single-arm registry to provide continuing&#xD;
      evaluation and periodic reporting of safety and effectiveness of Medtronic Neurovascular&#xD;
      market-released products used in the treatment of Intracranial aneurysms and Acute Ischemic&#xD;
      Stroke.&#xD;
&#xD;
      This study is conducted under the Product Surveillance Registry (NCT01524276).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">November 2026</completion_date>
  <primary_completion_date type="Anticipated">November 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).</measure>
    <time_frame>1 year</time_frame>
    <description>For Intracranial Aneurysm the primary outcome is the clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Independence: mRS score ≤ 2</measure>
    <time_frame>90 days</time_frame>
    <description>For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2</description>
  </primary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Intracranial Aneurysm</condition>
  <condition>Stroke, Ischemic</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Treatment for intracranial aneurysms</intervention_name>
    <description>Embolization of aneurysms</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Treatment for Acute Ischemic Stroke</intervention_name>
    <description>Revascularization of an intracranial blood vessel</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Intracranial aneurysms: Patients requiring treatment for intracranial aneurysms with market&#xD;
        approved Medtronic flow diverters, intrasaccular devices or vascular reconstruction devices&#xD;
        are eligible for the registry.&#xD;
&#xD;
        Acute Ischemic Stroke: Patients requiring treatment for Acute Ischemic Stroke due to&#xD;
        intracranial vessel occlusion with Medtronic market approved aspiration and/or&#xD;
        revascularization devices are eligible for the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient or legally authorized representative (LAR) provides authorization and/or&#xD;
             consent per institution and geographical requirements&#xD;
&#xD;
          -  Patient has, or is intended to receive or be treated with, an eligible Medtronic&#xD;
             product&#xD;
&#xD;
          -  Patient is consented within the enrollment window of the therapy received, as&#xD;
             applicable&#xD;
&#xD;
          -  Patient is at least 18 years of age at time of enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who is, or is expected to be inaccessible for follow-up&#xD;
&#xD;
          -  Patient with exclusion criteria required by local law&#xD;
&#xD;
          -  Patient is currently enrolled in or plans to enroll in any concurrent drug and/or&#xD;
             device study that may confound results&#xD;
&#xD;
          -  Female patient who is known to be pregnant or is breastfeeding or wishes to become&#xD;
             pregnant during participation in the study.&#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>Markus Holtmannspotter, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Klinikum Nürnberg Süd</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laurent Spelle, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hôpital Bicêtre, Service de Neuroradiologie Interventionnelle Adulte et Pédiatrique</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jens Fiehler, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
  </overall_official>
  <overall_official>
    <last_name>István Szikora, MD</last_name>
    <role>Study Chair</role>
    <affiliation>National Institute of Clinical Neurosciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mario Galdamez, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Clínico Universitario de Valladolid</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Saleh Lamin, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Queen Elisabeth Hospital, Neuroradiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francis Turjman, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hôpital Pierre Wertheimer</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christophe Cognard, MD</last_name>
    <role>Study Chair</role>
    <affiliation>CHU Toulouse - Hôpital Purpan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Markus Möhlenbruch, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Heidelberg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marc Ribó, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Vall d'Hebron</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pasquale Mordasini, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Inselspital - Universitätsspital Bern</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sanjeev Nayak, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wouter Fabry</last_name>
    <phone>+32496165078</phone>
    <email>wouter.fabry@medtronic.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Beatrice Carlotta Sicurella</last_name>
    <phone>+390224137264</phone>
    <email>beatrice.carlotta.sicurella@medtronic.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>ENERI</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gold Coast University Hospital</name>
      <address>
        <city>Southport</city>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Christian Doppler Klinik Salzburg</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost Limburg - Campus Sint-Jan</name>
      <address>
        <city>Genk</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Xuanwu Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chongqing University Three Gorges Hospital</name>
      <address>
        <city>Chongqing</city>
        <zip>404000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Jinggangshan University</name>
      <address>
        <city>Ji'an</city>
        <zip>343600</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Jiamusi University</name>
      <address>
        <city>Jiamusi</city>
        <zip>154000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kaifeng Central Hospital</name>
      <address>
        <city>Kaifeng</city>
        <zip>475000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Liaocheng People's Hospital</name>
      <address>
        <city>Liaocheng</city>
        <zip>252001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Lishui Municipal Central Hospital</name>
      <address>
        <city>Lishui</city>
        <zip>323020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Panzhihua Central Hospital</name>
      <address>
        <city>Panzhihua</city>
        <zip>617067</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Qujing First Peoples Hospital</name>
      <address>
        <city>Qujing</city>
        <zip>655000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shanxi Cardiovascular Hospital</name>
      <address>
        <city>Taiyuan</city>
        <zip>30024</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital Of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Zhuhai Peoples Hospital</name>
      <address>
        <city>Zhuhai</city>
        <zip>519070</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Turun Yliopistollinen keskussairaala</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Besancon - Hôpital Jean Minjoz</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux - Centre Universitaire Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Brest, Hôpital de la Cavale Blanche</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Pierre Wertheimer</name>
      <address>
        <city>Bron</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AP-HP Hôpital Bicêtre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Limoges - Hôpital Dupuytren</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Timone-CHU de Marseille</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier - Hôpital Gui de Chauliac</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Nancy - Hôpital Central</name>
      <address>
        <city>Nancy</city>
        <zip>54035</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes Hôpital Laennec</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>GHU Paris Psychiatrie &amp; Neurosciences</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fondation Ophtalmologique Adolphe de Rothschild</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Pitié Salpétrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Reims Hôpital Maison Blanche</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>CHU Hôpitaux de Rouen - Hôpital Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse - Hôpital Pierre-Paul Riquet</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHRU de Tours - Hôpital Brettoneau</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Bretagne Atlantique Vannes - Auray</name>
      <address>
        <city>Vannes</city>
        <zip>56000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Augsburg</name>
      <address>
        <city>Augsburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin -Campus Charite</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>HELIOS Klinikum Erfurt</name>
      <address>
        <city>Erfurt</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alfried Krupp Krankenhaus</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79065</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>LMU Klinikum der Universität München</name>
      <address>
        <city>Munich</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg - Klinikum Nürnberg Süd</name>
      <address>
        <city>Nürnberg</city>
        <zip>90471</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hellenic Airforce 251 General Hospital</name>
      <address>
        <city>Athen</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Országos Klinikai Idegtudományi Intézet</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Careggi</name>
      <address>
        <city>Firenze</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedale Niguarda Cà Granda</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Military Medical Institute-Wojskowy Instytut Medyczny</name>
      <address>
        <city>Warszawa</city>
        <zip>04-141</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I</name>
      <address>
        <city>Vila Nova de Gaia</city>
        <zip>4434-502</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Siberian Federal Biomedical Research Center</name>
      <address>
        <city>Novosibirsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Almazov National Medical Research Centre</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CINRE s.r.o.</name>
      <address>
        <city>Bratislava</city>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chris Hani Baragwaneth Hospital</name>
      <address>
        <city>Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Hospital De Cruces</name>
      <address>
        <city>Barakaldo</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Vall D'Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Fundación Jiménez Díaz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Donostia</name>
      <address>
        <city>San Sebastián</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Álvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Inselspital - Universitätsspital Bern</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Genève</name>
      <address>
        <city>Geneve</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic - Abu Dhabi</name>
      <address>
        <city>Abu Dhabi</city>
        <country>United Arab Emirates</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust - Charing Cross Hospital</name>
      <address>
        <city>London</city>
        <zip>W6 8RF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Barking, Havering and Redbridge University Hospitals - Queen's Hospital</name>
      <address>
        <city>Romford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital</name>
      <address>
        <city>Stoke on Trent</city>
        <zip>ST4 6QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>China</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Arab Emirates</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>July 3, 2023</last_update_submitted>
  <last_update_submitted_qc>July 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Embolization Device</keyword>
  <keyword>Flow Diverter</keyword>
  <keyword>Intra saccular device</keyword>
  <keyword>Vascular Reconstruction Device</keyword>
  <keyword>Ruptured Intracranial Aneurysm</keyword>
  <keyword>Unruptured Intracranial Aneurysm</keyword>
  <keyword>Large Vessel Occlusion</keyword>
  <keyword>Stent Retriever</keyword>
  <keyword>Aspiration Catheter</keyword>
  <keyword>Revascularization Device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only multi center data will be available</ipd_description>
  </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/NCT02988128
org study id: MDT16056/MDT17077
nct id: NCT02988128
lead sponsor: 
collaborator: 
has dmc: No
Post market surveillance registry
An observational, prospective, multi-center, single-arm registry to provide continuing
      evaluation and periodic reporting of safety and effectiveness of Medtronic Neurovascular
      market-released products used in the treatment of Intracranial aneurysms and Acute Ischemic
      Stroke.

      This study is conducted under the Product Surveillance Registry (NCT01524276).
observational model: Cohort
time perspective: Prospective
measure: The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).
time frame: 1 year
description: For Intracranial Aneurysm the primary outcome is the clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).
measure: Functional Independence: mRS score ≤ 2
time frame: 90 days
description: For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2
intervention type: Device
intervention name: Treatment for intracranial aneurysms
description: Embolization of aneurysms
intervention type: Device
intervention name: Treatment for Acute Ischemic Stroke
description: Revascularization of an intracranial blood vessel
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Markus Holtmannspotter, MD
role: Study Chair
affiliation: Klinikum Nürnberg Süd
last name: Laurent Spelle, MD
role: Study Chair
affiliation: Hôpital Bicêtre, Service de Neuroradiologie Interventionnelle Adulte et Pédiatrique
last name: Jens Fiehler, MD
role: Study Chair
affiliation: Universitätsklinikum Hamburg-Eppendorf
last name: István Szikora, MD
role: Study Chair
affiliation: National Institute of Clinical Neurosciences
last name: Mario Galdamez, MD
role: Study Chair
affiliation: Hospital Clínico Universitario de Valladolid
last name: Saleh Lamin, MD
role: Study Chair
affiliation: Queen Elisabeth Hospital, Neuroradiology
last name: Francis Turjman, MD
role: Study Chair
affiliation: Hôpital Pierre Wertheimer
last name: Christophe Cognard, MD
role: Study Chair
affiliation: CHU Toulouse - Hôpital Purpan
last name: Markus Möhlenbruch, MD
role: Study Chair
affiliation: University Hospital Heidelberg
last name: Marc Ribó, MD
role: Study Chair
affiliation: Hospital Vall d'Hebron
last name: Pasquale Mordasini, MD
role: Study Chair
affiliation: Inselspital - Universitätsspital Bern
last name: Sanjeev Nayak, MD
role: Study Chair
affiliation: University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
last name: Wouter Fabry
phone: +32496165078
email: wouter.fabry@medtronic.com
last name: Beatrice Carlotta Sicurella
phone: +390224137264
email: beatrice.carlotta.sicurella@medtronic.com
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
country: Argentina
country: Australia
country: Austria
country: Belgium
country: China
country: Denmark
country: Finland
country: France
country: Germany
country: Greece
country: Hong Kong
country: Hungary
country: Israel
country: Italy
country: Poland
country: Portugal
country: Russian Federation
country: Slovakia
country: South Africa
country: Spain
country: Switzerland
country: United Arab Emirates
country: United Kingdom
responsible party type: Sponsor
mesh term: Intracranial Aneurysm
mesh term: Ischemic Stroke
mesh term: Aneurysm
sharing ipd: No
ipd description: Only multi center data will be available