<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/NCT04503395</url>
  </required_header>
  <id_info>
    <org_study_id>FCRE-191125</org_study_id>
    <nct_id>NCT04503395</nct_id>
  </id_info>
  <brief_title>ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES</brief_title>
  <acronym>SOCRATES</acronym>
  <official_title>Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FCRE (Foundation for Cardiovascular Research and Education)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>FCRE (Foundation for Cardiovascular Research and Education)</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>
      The aim of this randomized study is to compare the safety and performance of EndoVascular&#xD;
      Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using&#xD;
      customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda&#xD;
      Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 21, 2021</start_date>
  <completion_date type="Anticipated">June 1, 2028</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2026</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>
    <intervention_model_description>comparision of two different procedure to repair abdominal aortic aneurysms with short necks</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness Endpoint - Technical Success</measure>
    <time_frame>through 12 months post-procedure</time_frame>
    <description>Composite of technical success at index procedure, and freedom from type IA or type III endoleak, freedom from aneurysm related mortality (ARM), and freedom from secondary reinterventions through 12 months post index procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety Endpoint - Freedom from Major Adverse Events</measure>
    <time_frame>through 30 days post-procedure</time_frame>
    <description>Freedom from MAE through 30 days post index procedure. MAE defined as: All-Cause-Mortality, Bowel Ischemia, Myocardial Infraction, Procedural Blood Loss &gt; 1000cc, Access related complications, permanent paraplegia and paraparesis at 30 days, disabling stroke, respiratory failure, or renal complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total contrast volume (ml) at index procedure</measure>
    <time_frame>at index procedure</time_frame>
    <description>Total contrast volume (mL) at index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total fluoroscopy time (minutes) at index procedure</measure>
    <time_frame>at index procedure</time_frame>
    <description>Total fluoroscopy time (minutes) at index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration (minutes) of index procedure</measure>
    <time_frame>at index procedure</time_frame>
    <description>3. Duration (minutes) of index procedure (time between initial skin access to final closure of the last artery access site)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequate penetration of endo anchors as accessed by the Core Lab</measure>
    <time_frame>at index procedure</time_frame>
    <description>Adequate penetration of endo anchors as accessed by the Core Lab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>through 30 days post-procedure</time_frame>
    <description>7. Clinical success defined as technical success + freedom from intra-operative death and freedom from type IA/III endoleak in the first post-op image within 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up</measure>
    <time_frame>through 1,12,24 and 36-months post-op</time_frame>
    <description>Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up</measure>
    <time_frame>through 1,12,24 and 36-months post-op</time_frame>
    <description>Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up</measure>
    <time_frame>through 1,12,24 and 36-months post-op</time_frame>
    <description>Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up</measure>
    <time_frame>through 1,12,24 and 36-months post-op</time_frame>
    <description>Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from stent graft migration (&gt;10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up</measure>
    <time_frame>through 12,24 and 36-months post-op</time_frame>
    <description>Freedom from stent graft migration (&gt;10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sac dynamics (&gt;5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up</measure>
    <time_frame>through 12,24 and 36-months post-op</time_frame>
    <description>Sac dynamics (&gt;5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up</measure>
    <time_frame>through 1,12,24 and 36-months post-op</time_frame>
    <description>Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up</measure>
    <time_frame>through 1,12,24 and 36-months post-op</time_frame>
    <description>Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall SCI rate, include transient events at 1 and 12 months follow-up</measure>
    <time_frame>through 1 and 12 months post-op</time_frame>
    <description>Overall SCI rate, include transient events at 1 and 12 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from aortic neck-related secondary interventions</measure>
    <time_frame>at 1-, 12-, 24- and 36-months follow-up</time_frame>
    <description>reinterventions for Type IAa endoleak, migration of the proximal stent graft, and progression of disease in the infrarenal aortic neck; progression of disease is defined as enlargement of the infrarenal aortic neck compared to the first postprocedural CT scan, as measured by either diameter, surface and/or volume.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">204</enrollment>
  <condition>Aortic Aneurysm, Abdominal</condition>
  <arm_group>
    <arm_group_label>ESAR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endovascular Aneurysm Repair + Heli-FX EndoAnchors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FEVAR</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fenestrated EndoVascular Aneurysm Repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ESAR treatment: Endograft + Heli-FX Endoanchor</intervention_name>
    <description>ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor</description>
    <arm_group_label>ESAR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FEVAR treatment : Fenestrated endograft</intervention_name>
    <description>Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft</description>
    <arm_group_label>FEVAR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is &gt;18 years old&#xD;
&#xD;
          -  Subject is scheduled for primary treatment of the abdominal aortic aneurysm with a&#xD;
             non-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that is&#xD;
             sufficiently healthy for a proximal neck length that is at least 4mm and not more&#xD;
             than15 mm and has a circumferential minimum sealing zone length of 8 mm&#xD;
&#xD;
          -  Subject is not a candidate for safe and effective standard EVAR&#xD;
&#xD;
          -  Subject is able and willing to comply with the protocol and to adhere to the follow-up&#xD;
             requirements.&#xD;
&#xD;
          -  Subject has provided written informed consent&#xD;
&#xD;
          -  Subject meets the other anatomical requirements according to the locally applicable&#xD;
             Endurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo Fenestrated&#xD;
             Anaconda (available in EU only) and/or Cook Zenith Fenestrated Graft Instructions for&#xD;
             Use&#xD;
&#xD;
          -  Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing&#xD;
             zone of 8mm&#xD;
&#xD;
          -  Aortic neck diameter from 19 to 31mm&#xD;
&#xD;
          -  Infrarenal neck angulation ≤45°&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is participating in a concurrent study which may confound study results&#xD;
&#xD;
          -  Subject has a life expectancy &lt;2 year&#xD;
&#xD;
          -  Subject is female of childbearing potential in whom pregnancy cannot be excluded&#xD;
&#xD;
          -  Subject with eGFR &lt;30 mL/min/m2 (KDOQI classification - exclude class IV and above)&#xD;
             and or on dialysis&#xD;
&#xD;
          -  Subject with a MI or CVA within 3 months prior to index procedure&#xD;
&#xD;
          -  Subject with known Connective Tissue Disease&#xD;
&#xD;
          -  Subject has a known hypersensitivity or contraindication to anticoagulants,&#xD;
             antiplatelets, or contrast media, which is not amenable to post-treatment&#xD;
&#xD;
          -  Subject who has undergone prior endovascular or open surgical treatment for abdominal&#xD;
             aortic aneurysm&#xD;
&#xD;
          -  Subject requires emergent aneurysm treatment, for example, trauma or rupture&#xD;
&#xD;
          -  Subject has a known hypersensitivity or allergies to study device implant material&#xD;
&#xD;
          -  Subject has an aneurysm that is:&#xD;
&#xD;
               -  Suprarenal, pararenal, or thoracoabdominal&#xD;
&#xD;
               -  Mycotic&#xD;
&#xD;
               -  Inflammatory&#xD;
&#xD;
               -  Pseudoaneurysm&#xD;
&#xD;
          -  Subject is presenting with thrombus or calcification of the proximal aneurysm neck:&#xD;
             circumferential &gt;50%&#xD;
&#xD;
          -  Pre-op stenosis of the renal arteries &gt; 50%&#xD;
&#xD;
          -  Subject has active infection or history of COVID-19. History of COVID-19 is defined as&#xD;
             availability of positive COVID-19 test with sequelae or hospitalization for treatment&#xD;
             of COVID-19.&#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>Giovanni Torsello, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vascupedia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brant Ullery, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Director, Vascular Surgery Providence Heart and Vascular Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Annelena Held-Wehmöller, PhD</last_name>
    <phone>+49 15785128140</phone>
    <email>info@fcre.eu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarah Litterscheid</last_name>
    <phone>+49 15785319015</phone>
    <email>sarah.litterscheid@fcre.eu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Ottakring, Institute for Vascular Surgery</name>
      <address>
        <city>Vienna</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Afshin Assadian</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CRC thoracic Vascular Surgery, ZOL Genk</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wouter Lansink, Dr MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent, Thoracale en vasculaire heelkunde</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle vanHerzeele</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Amrois Paré Hospital (APHP)</name>
      <address>
        <city>Boulogne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raphael Coscas</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Service de Chirurgie Vasculaire et Endovasculaire CHU Gabriel-Montpied 58 rue Montalembert</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabien Thaveau</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de lyon - Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine Millon</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adrien Kaladji</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital RWTH Aachen</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Drosos Kotelis</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04109</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dierk Scheinert</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital LMU Munich</name>
      <address>
        <city>Munich</city>
        <zip>81337</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Martin Austermann</name>
      <address>
        <city>Münster</city>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospital Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>University of Bologna, IRCCS S. Orsola Hospital,</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mauro Gargiulo, Prof</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale San Raffaele, Chirurgia Vascolare</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Kahlberg, Prof</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vascular Endovascular Surgery University of Perugia;</name>
      <address>
        <city>Perugia</city>
        <zip>06100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Massimo Lenti, Prof MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Giacomo Isernia, MD, PHD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>VUMC Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kak Khee Yeung</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Philippe Cuypers</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon Y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrés Reyer</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Donostia</name>
      <address>
        <city>San Sebastián</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariano de Blas</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern, Universitätsklinik für Gefässchirurgie</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Drosos Kotelis, Prof</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>FCRE (Foundation for Cardiovascular Research and Education)</investigator_affiliation>
    <investigator_full_name>Dr. Sabrina Overhagen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04503395
org study id: FCRE-191125
nct id: NCT04503395
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this randomized study is to compare the safety and performance of EndoVascular
      Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using
      customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda
      Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: comparision of two different procedure to repair abdominal aortic aneurysms with short necks
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness Endpoint - Technical Success
time frame: through 12 months post-procedure
description: Composite of technical success at index procedure, and freedom from type IA or type III endoleak, freedom from aneurysm related mortality (ARM), and freedom from secondary reinterventions through 12 months post index procedure.
measure: Safety Endpoint - Freedom from Major Adverse Events
time frame: through 30 days post-procedure
description: Freedom from MAE through 30 days post index procedure. MAE defined as: All-Cause-Mortality, Bowel Ischemia, Myocardial Infraction, Procedural Blood Loss > 1000cc, Access related complications, permanent paraplegia and paraparesis at 30 days, disabling stroke, respiratory failure, or renal complications
measure: Total contrast volume (ml) at index procedure
time frame: at index procedure
description: Total contrast volume (mL) at index procedure
measure: Total fluoroscopy time (minutes) at index procedure
time frame: at index procedure
description: Total fluoroscopy time (minutes) at index procedure
measure: Duration (minutes) of index procedure
time frame: at index procedure
description: 3. Duration (minutes) of index procedure (time between initial skin access to final closure of the last artery access site)
measure: Adequate penetration of endo anchors as accessed by the Core Lab
time frame: at index procedure
description: Adequate penetration of endo anchors as accessed by the Core Lab
measure: Clinical success
time frame: through 30 days post-procedure
description: 7. Clinical success defined as technical success + freedom from intra-operative death and freedom from type IA/III endoleak in the first post-op image within 30 days.
measure: Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up
time frame: through 1,12,24 and 36-months post-op
description: Visceral artery patency or occlusion at 1, 12, 24 and 36 months follow-up
measure: Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up
time frame: through 1,12,24 and 36-months post-op
description: Freedom from type Ia and III endoleaks at 1, 12, 24 and 36 months follow-up
measure: Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up
time frame: through 1,12,24 and 36-months post-op
description: Freedom from aneurysm related secondary reinterventions at 1, 12, 24 and 36 months follow-up
measure: Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up
time frame: through 1,12,24 and 36-months post-op
description: Freedom from aneurysm related mortality at 1, 12, 24 and 36 months follow-up
measure: Freedom from stent graft migration (>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up
time frame: through 12,24 and 36-months post-op
description: Freedom from stent graft migration (>10mm change from 1-month follow-up imaging) at 12, 24 and 36 months follow-up
measure: Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up
time frame: through 12,24 and 36-months post-op
description: Sac dynamics (>5mm change from 1-month follow-up imaging): increase, stable, decrease at 12, 24, and 36 months follow-up
measure: Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up
time frame: through 1,12,24 and 36-months post-op
description: Freedom from conversion to open repair at 1, 12, 24 and 36 months follow-up
measure: Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up
time frame: through 1,12,24 and 36-months post-op
description: Freedom from AAA rupture at 1, 12, 24 and 36 months follow-up
measure: Overall SCI rate, include transient events at 1 and 12 months follow-up
time frame: through 1 and 12 months post-op
description: Overall SCI rate, include transient events at 1 and 12 months follow-up
measure: Freedom from aortic neck-related secondary interventions
time frame: at 1-, 12-, 24- and 36-months follow-up
description: reinterventions for Type IAa endoleak, migration of the proximal stent graft, and progression of disease in the infrarenal aortic neck; progression of disease is defined as enlargement of the infrarenal aortic neck compared to the first postprocedural CT scan, as measured by either diameter, surface and/or volume.
arm group label: ESAR
arm group type: Experimental
description: Endovascular Aneurysm Repair + Heli-FX EndoAnchors
arm group label: FEVAR
arm group type: Active Comparator
description: Fenestrated EndoVascular Aneurysm Repair
intervention type: Device
intervention name: ESAR treatment: Endograft + Heli-FX Endoanchor
description: ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
arm group label: ESAR
intervention type: Device
intervention name: FEVAR treatment : Fenestrated endograft
description: Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft
arm group label: FEVAR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giovanni Torsello, Prof. Dr.
role: Principal Investigator
affiliation: Vascupedia
last name: Brant Ullery, MD, MBA
role: Principal Investigator
affiliation: Medical Director, Vascular Surgery Providence Heart and Vascular Institute
last name: Annelena Held-Wehmöller, PhD
phone: +49 15785128140
email: info@fcre.eu
last name: Sarah Litterscheid
phone: +49 15785319015
email: sarah.litterscheid@fcre.eu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Suspended
facility: 
status: Active, not recruiting
facility: 
status: Suspended
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Austria
country: Belgium
country: France
country: Germany
country: Italy
country: Netherlands
country: Spain
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: FCRE (Foundation for Cardiovascular Research and Education)
investigator full name: Dr. Sabrina Overhagen
investigator title: Principal Investigator
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
sharing ipd: No