<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/NCT04471909</url>
  </required_header>
  <id_info>
    <org_study_id>CIP-009</org_study_id>
    <nct_id>NCT04471909</nct_id>
  </id_info>
  <brief_title>NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness</brief_title>
  <acronym>TRIOMPHE</acronym>
  <official_title>A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endospan Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endospan Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch&#xD;
      Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the&#xD;
      aortic arch with a proximal landing zone, native or previously implanted surgical graft, in&#xD;
      the ascending aorta and with a brachiocephalic trunk native landing zone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 20, 2020</start_date>
  <completion_date type="Anticipated">January 2027</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device Technical Failure</measure>
    <time_frame>30 Days</time_frame>
    <description>Failure to accurately deliver, track and deploy all required endovascular device components at the intended implantation site and failure to retrieve the device delivery systems without the need for unplanned additional procedures&#xD;
Device occlusion&#xD;
Failed exclusion of primary entry tear&#xD;
Additional unanticipated surgical or interventional procedure related to the device or procedure, to prevent life-threatening or permanent disabling event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Failure</measure>
    <time_frame>30 Days</time_frame>
    <description>Subjects experiencing early mortality or at least one of the following MAEs through 30-Day of Phase 1 Procedure and 30-Day of Index Procedure: Disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, development of new dissections in the thoracic aorta or brachiocephalic artery.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Aortic Dissection</condition>
  <condition>Aortic Aneurysm</condition>
  <condition>Intramural Hematoma</condition>
  <condition>Penetrating Aortic Ulcer</condition>
  <arm_group>
    <arm_group_label>Chronic Dissection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Aneurysm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Penetrating Aortic Ulcer and/or Intramural Hematoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NEXUS Aortic Stent Graft System</intervention_name>
    <description>Arch Stent Graft, whose cranial narrow end is intended to be deployed into the Brachiocephalic artery and whose distal end is intended to be deployed into the Descending Thoracic Aorta.&#xD;
Ascending Stent Graft intended to be deployed in the Ascending Aorta.&#xD;
OPTIONAL: Descending Extension can be used in case the aortic lesion elongates further distally and out of the covered length offered by the Arch Stent Graft. Multiple Descending Extensions can be used if needed to cover the entire length of the lesion.</description>
    <arm_group_label>Aneurysm</arm_group_label>
    <arm_group_label>Chronic Dissection</arm_group_label>
    <arm_group_label>Penetrating Aortic Ulcer and/or Intramural Hematoma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female age ≥ 18.&#xD;
&#xD;
          2. Proximal/ascending native or previously implanted surgical graft landing zone of&#xD;
             appropriate length&#xD;
&#xD;
          3. Proximal/ascending native or previously implanted surgical graft landing zone of&#xD;
             appropriate diameter&#xD;
&#xD;
          4. Distal/descending native landing zone of appropriate length&#xD;
&#xD;
          5. Distal/descending native landing zone of appropriate diameter&#xD;
&#xD;
          6. Brachiocephalic trunk native landing zone of appropriate length&#xD;
&#xD;
          7. Brachiocephalic trunk native landing zone of appropriate diameter&#xD;
&#xD;
          8. Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch&#xD;
             perpendicular&#xD;
&#xD;
          9. Appropriate aortic arch perpendicular diameter&#xD;
&#xD;
         10. Chronic dissection with at least one of the following conditions:&#xD;
&#xD;
               1. An aortic aneurysm with a maximum diameter ≥ 55 mm&#xD;
&#xD;
               2. Rapidly expanding false lumen (growth of &gt; 0.5 cm/6 months)&#xD;
&#xD;
               3. Compressed true lumen associated with end organ malperfusion&#xD;
&#xD;
               4. Symptomatic&#xD;
&#xD;
         11. Aneurysm with at least one of the following conditions:&#xD;
&#xD;
               1. Dilatation of the aortic arch larger than 5 cm in diameter for subject with&#xD;
                  fusiform aneurysm&#xD;
&#xD;
               2. Dilatation of the aortic arch is 1.5 times the normal diameter for subjects&#xD;
                  ascending or descending&#xD;
&#xD;
               3. Dilation of the aortic arch larger than 2.5 cm for subject with saccular aneurysm&#xD;
&#xD;
               4. Symptomatic aneurysm of the aortic arch&#xD;
&#xD;
               5. Aortic diameter growth rate &gt; 5mm per 6 months&#xD;
&#xD;
               6. Postoperative pseudoaneurysm expanding from anastomotic suture lines&#xD;
&#xD;
         12. Penetrating aortic ulcer with at least one of the following:&#xD;
&#xD;
               1. Symptomatic&#xD;
&#xD;
               2. Ulcer demonstrates expansion&#xD;
&#xD;
         13. Intramural hematoma with at least one of the following:&#xD;
&#xD;
               1. Symptomatic (persistent pain)&#xD;
&#xD;
               2. Transverse or longitudinal expansion on serial imaging&#xD;
&#xD;
         14. In the event of a lesion in the ascending aortic, the proximal/ascending native or&#xD;
             previously implanted surgical graft the landing zone must be appropriate&#xD;
&#xD;
         15. Femoral / iliac artery diameter as documented by CTA or MRA that allows endovascular&#xD;
             access to the diseased site with a 20 Fr. delivery catheter.&#xD;
&#xD;
         16. Access vessels morphology suitable for endovascular repair in terms of tortuosity,&#xD;
             calcification and angulation, documented by CTA/MRA.&#xD;
&#xD;
         17. Brachial/Axial Artery diameter that allows endovascular access suitable for 7 Fr.&#xD;
&#xD;
         18. Subject is considered an appropriate candidate for an elective surgery.&#xD;
&#xD;
         19. Subject is considered to be at high risk for open repair, as determined by the&#xD;
             investigator.&#xD;
&#xD;
         20. Access vessels, iliac/femoral &amp; brachial/axillary compatible with vascular access&#xD;
             techniques (femoral cutdown or percutaneous), devices, and /or accessories.&#xD;
&#xD;
         21. Subject is willing and able to comply with procedures specified in the protocol and is&#xD;
             able to return for follow-up visits as specified by the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute dissection&#xD;
&#xD;
          2. Lesions that can be safely treated with TEVAR landing in zone 2 (with or w/o LSA&#xD;
             vascularization)&#xD;
&#xD;
          3. Required emergent treatment, e.g., trauma, rupture&#xD;
&#xD;
          4. Acute vascular injury of the aorta due to trauma&#xD;
&#xD;
          5. Aortic rupture or unstable aneurysm&#xD;
&#xD;
          6. Received a previous stent or stent graft in the treated area (including planned&#xD;
             landing area)&#xD;
&#xD;
          7. Required surgical or endovascular treatment of an infra-renal aneurysm at time of&#xD;
             implantation&#xD;
&#xD;
          8. Planned major surgical or interventional procedure at time of screening, to be&#xD;
             performed after the NEXUS™ implantation.&#xD;
&#xD;
          9. Any major surgical or interventional procedure 6 weeks before the NEXUS™ implantation,&#xD;
             exclusive of planned procedures that are needed for the safe and effective placement&#xD;
             of the stent graft (e.g. supra-aortic bypass).&#xD;
&#xD;
         10. Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA)&#xD;
             within 90 days prior to the planned implantation&#xD;
&#xD;
         11. Subjects with severe aortic valvular insufficiency as determined by echocardiography&#xD;
&#xD;
         12. Mechanical valve that preclude safe delivery of NEXUS™&#xD;
&#xD;
         13. Known Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes)&#xD;
&#xD;
         14. Subject has an active systemic infection at the time of the procedure documented by&#xD;
             pain, fever, drainage, positive culture&#xD;
&#xD;
         15. Pregnant&#xD;
&#xD;
         16. Life expectancy of less than 2 years&#xD;
&#xD;
         17. Unsuitable vascular anatomy&#xD;
&#xD;
         18. Subject who have a previously implanted surgical wrap of the ascending aorta&#xD;
&#xD;
         19. Any medical condition that, according to the investigator's decision, might expose the&#xD;
             subject to increased risk by the investigational device or procedure.&#xD;
&#xD;
         20. An aneurysm that is mycotic, inflammatory or suspected to be infected.&#xD;
&#xD;
         21. Subject with hostile groins/axilla (scarring, obesity, or previous failed puncture)&#xD;
             unless conduit are used.&#xD;
&#xD;
         22. Subjects with severe atherosclerosis, severe calcification or extensive intraluminal&#xD;
             thrombus of the aorta or in the brachiocephalic trunk&#xD;
&#xD;
         23. Subject is suffering from unstable angina or NYHA classification III and IV.&#xD;
&#xD;
         24. Subject has a known hypersensitivity or contraindication to anticoagulants,&#xD;
             antiplatelets, or contrast media, which is not amenable to pre-treatment.&#xD;
&#xD;
         25. Subject with a contraindication to undergo angiography&#xD;
&#xD;
         26. Subject with known sensitivities or allergies to the device materials (including&#xD;
             Nitinol [NiTi], polyester fabric [PET], tantalum [TA])&#xD;
&#xD;
         27. Clinical conditions that severely inhibit x-ray visualization of the Aorta.&#xD;
&#xD;
         28. Subject has history of bleeding diathesis or coagulopathy that may limit the use of&#xD;
             dual antiplatelet or anticoagulant therapy by the decision of the investigator&#xD;
&#xD;
         29. Acute renal failure; chronic renal failure (excluding dialysis); Creatinine &gt; 2.00&#xD;
             mg/dl&#xD;
&#xD;
         30. Any other medical, social, or psychological issues that in the opinion of the&#xD;
             investigator preclude them from receiving this treatment, or the procedures and&#xD;
             evaluations pre- and post- treatment.&#xD;
&#xD;
         31. Active participation in another clinical study that has not completed primary&#xD;
             endpoint(s) evaluation or that clinically interferes with the endpoints in this study,&#xD;
             or subject is planning to participate in such study prior to the completion of this&#xD;
             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_contact>
    <last_name>Jessica Kleine</last_name>
    <phone>(612)2800208</phone>
    <email>j.Kleine@endospan.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jennifer Miller</last_name>
    <email>j.miller@endospan.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alabama Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebecca St. John</last_name>
      <email>rstjohn@uabmc.edu</email>
    </contact>
    <investigator>
      <last_name>Adam Beck, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kyle Eudailey, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California San Diego Medical Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathleen Groh</last_name>
      <email>kagroh@health.ucsd.edu</email>
    </contact>
    <investigator>
      <last_name>John Lane, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eugene Golts, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UC Davis Health</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ashley Truong</last_name>
      <email>ashtruon@ucdavis.org</email>
    </contact>
    <investigator>
      <last_name>Steven Maximus</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bob Kiaii</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tiffany Koyano</last_name>
      <phone>650-724-6921</phone>
      <email>tkoyano3@stanford.edu</email>
    </contact>
    <investigator>
      <last_name>Claire Watkins, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jason Lee, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Piña</last_name>
      <email>andrea.pinalimones@cuanschutz.edu</email>
    </contact>
    <investigator>
      <last_name>Brett Reece, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Donald Jacobs, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hartford Healthcare</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alison Champagne</last_name>
      <email>Alison.champagne@hhchealth.org</email>
    </contact>
    <investigator>
      <last_name>Mohiuddin Cheema</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>James Gallagher</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jayne Thompson</last_name>
      <email>sjdanle@emory.edu</email>
    </contact>
    <investigator>
      <last_name>Bradley Leshnower, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yazan Duwayri, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scully Hsu</last_name>
      <email>shsu@bsd.uchicago.edu</email>
    </contact>
    <investigator>
      <last_name>Trissa Babrowski, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Takeyoshi Ota, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ascension St. Vincent</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hannah Willard</last_name>
      <email>hannah.jenkins1@ascension.org</email>
    </contact>
    <investigator>
      <last_name>Sina Moainie</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brent Mardsen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Fleischmann</last_name>
      <email>EFleischmann@som.umaryland.edu</email>
    </contact>
    <investigator>
      <last_name>Bradley Taylor, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shahab Toursavadkohi, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gaurav Das</last_name>
      <email>gdas@tuftsmedicalcenter.org</email>
    </contact>
    <investigator>
      <last_name>Payam Salehi</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yong Zhan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amanda Kasperek</last_name>
      <email>kasperea@med.umich.edu</email>
    </contact>
    <investigator>
      <last_name>Himanshu Patel, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Williams, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura McDonald</last_name>
      <email>m.laura@wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Luis Sanchez, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marc Moon, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwell Health Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nhan Tran</last_name>
      <email>NNguyenTran@northwell.edu</email>
    </contact>
    <investigator>
      <last_name>Derek Brinster, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alfio Carroccio, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Atrium Health</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dana Amaro</last_name>
      <email>Dana.Amaro@atriumhealth.org</email>
    </contact>
    <investigator>
      <last_name>Frank Arko, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>John Frederick, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susan Hajmohammad</last_name>
      <email>susan.hajmohammad@duke.edu</email>
    </contact>
    <investigator>
      <last_name>Chad Hughes, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chandler Long, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Lindner Research Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Hoyle</last_name>
      <email>mark.hoyle@thechristhospital.com</email>
    </contact>
    <investigator>
      <last_name>Geoffrey Answini, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mark Harding, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Mitchell</last_name>
      <email>sarah.mitchell4@uhhospitals.org</email>
    </contact>
    <investigator>
      <last_name>Jae Cho</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yakov Elgudin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oregon Health</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Derek Darby</last_name>
      <email>darby@ohsu.edu</email>
    </contact>
    <investigator>
      <last_name>Castigliano Bhamidipati, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cherrie Abraham, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Cichonski</last_name>
      <email>Elizabeth.Cichonski@pennmedicine.upenn.edu</email>
    </contact>
    <investigator>
      <last_name>Nimesh Desai, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Grace Wang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lankenau Medical Center</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ebuwa Erebor</last_name>
      <email>EreborE@mlhs.org</email>
    </contact>
    <investigator>
      <last_name>Robert Rodriguez, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>William Gray, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Korenn</last_name>
      <email>korenn@musc.edu</email>
    </contact>
    <investigator>
      <last_name>Sanford Zeigler, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ravi Veeraswamy, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ballad Health</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Vines</last_name>
      <email>lisa.vines@balladhealth.org</email>
    </contact>
    <investigator>
      <last_name>Robert Allen</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bryan Helsel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Slinger</last_name>
      <email>lisa.slinger@vumc.org</email>
    </contact>
    <investigator>
      <last_name>Melissa Levack</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel Clair</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baylor Scott and White</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elyza Guerrero</last_name>
      <email>Elyza.Guerrero@BSWHealth.org</email>
    </contact>
    <investigator>
      <last_name>William Brinkman, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dennis Gable, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sentara Norfolk General Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melinda Bullivant</last_name>
      <phone>757-388-4024</phone>
      <email>MMBULLIV@sentara.com</email>
    </contact>
    <investigator>
      <last_name>Christopher Barreiro, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean Panneton, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carilion Clinic</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yili Zhong</last_name>
      <email>yzhong@carilionclinic.org</email>
    </contact>
    <investigator>
      <last_name>Joshua Adams</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joseph Rowe</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital</name>
      <address>
        <city>Northwest</city>
        <state>Washington</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suman Singh</last_name>
      <email>Suman.Singh@Medstar.net</email>
    </contact>
    <investigator>
      <last_name>Javairiah Fatima, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christian Shults, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wendy Hamar</last_name>
      <email>wh12@uw.edu</email>
    </contact>
    <investigator>
      <last_name>Matthew Sweet, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christopher Burke, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <state>Grafton</state>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elleni Takele</last_name>
      <phone>09 307 4949</phone>
      <phone_ext>21976</phone_ext>
      <email>ElleniT@adhb.govt.nz</email>
    </contact>
    <contact_backup>
      <last_name>Hank Zhang</last_name>
      <email>HankZ@adhb.govt.nz</email>
    </contact_backup>
    <investigator>
      <last_name>Andrew Holden, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Hill, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>New Zealand</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 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>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Dissection</mesh_term>
    <mesh_term>Penetrating Atherosclerotic Ulcer</mesh_term>
    <mesh_term>Hematoma</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/NCT04471909
org study id: CIP-009
nct id: NCT04471909
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch
      Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the
      aortic arch with a proximal landing zone, native or previously implanted surgical graft, in
      the ascending aorta and with a brachiocephalic trunk native landing zone.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Device Technical Failure
time frame: 30 Days
description: Failure to accurately deliver, track and deploy all required endovascular device components at the intended implantation site and failure to retrieve the device delivery systems without the need for unplanned additional procedures
Device occlusion
Failed exclusion of primary entry tear
Additional unanticipated surgical or interventional procedure related to the device or procedure, to prevent life-threatening or permanent disabling event.
measure: Clinical Failure
time frame: 30 Days
description: Subjects experiencing early mortality or at least one of the following MAEs through 30-Day of Phase 1 Procedure and 30-Day of Index Procedure: Disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, development of new dissections in the thoracic aorta or brachiocephalic artery.
arm group label: Chronic Dissection
arm group type: Experimental
arm group label: Aneurysm
arm group type: Experimental
arm group label: Penetrating Aortic Ulcer and/or Intramural Hematoma
arm group type: Experimental
intervention type: Device
intervention name: NEXUS Aortic Stent Graft System
description: Arch Stent Graft, whose cranial narrow end is intended to be deployed into the Brachiocephalic artery and whose distal end is intended to be deployed into the Descending Thoracic Aorta.
Ascending Stent Graft intended to be deployed in the Ascending Aorta.
OPTIONAL: Descending Extension can be used in case the aortic lesion elongates further distally and out of the covered length offered by the Arch Stent Graft. Multiple Descending Extensions can be used if needed to cover the entire length of the lesion.
arm group label: Aneurysm
arm group label: Chronic Dissection
arm group label: Penetrating Aortic Ulcer and/or Intramural Hematoma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jessica Kleine
phone: (612)2800208
email: j.Kleine@endospan.com
last name: Jennifer Miller
email: j.miller@endospan.com
facility: 
status: Recruiting
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country: New Zealand
country: United States
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Dissection
mesh term: Penetrating Atherosclerotic Ulcer
mesh term: Hematoma