<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/NCT02201589</url>
  </required_header>
  <id_info>
    <org_study_id>PSIDE:Ascending Thoracic Aorta</org_study_id>
    <nct_id>NCT02201589</nct_id>
  </id_info>
  <brief_title>Feasibility of Endovascular Repair Of Ascending Aortic Pathologies</brief_title>
  <official_title>Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair Of Ascending Aortic Pathologies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rodney A. White, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the outcome of patients with pathologies of the&#xD;
      ascending thoracic aorta (diseases in the great blood vessel or artery that leads away from&#xD;
      the heart) including type A aortic dissection, retrograde type A aortic dissection,&#xD;
      intramural hematoma, penetrating ulcer or pseudoaneurysm who are suitable for endovascular&#xD;
      (within the vessel) repair with the Medtronic Valiant PS-IDE (Physician&#xD;
      Sponsored-Investigational Device Exemption) Stent Graft. Type A aortic dissection is a&#xD;
      condition where blood passes through the inner lining or between the layers of the blood&#xD;
      vessel from a tear in the aortic wall (dissection) in the ascending aorta; a retrograde Type&#xD;
      A aortic dissection is a condition where the dissection or tear in the ascending aorta starts&#xD;
      from the descending aorta; an intramural hematoma is a collection of clotted blood within the&#xD;
      aortic wall; a penetrating ulcer has a plaque or clot within the wall and a pseudoaneurysm is&#xD;
      a false aneurysm . If left untreated in any of these conditions, the aorta can enlarge and&#xD;
      rupture causing injury or death. The plan for these patients is to repair the ascending&#xD;
      thoracic aorta using the Medtronic Valiant PS-IDE Stent Graft with the Captivia Delivery&#xD;
      System. The Valiant Captivia has been evaluated worldwide and used extensively in patients&#xD;
      with type B (descending) thoracic aortic dissection. Since the dissections in the ascending&#xD;
      aortas mirror that of the descending aorta, it is expected that this stent graft will deliver&#xD;
      similar performance and endurance in patients with type A aortic dissection. The&#xD;
      investigators expect to reroute the blood to the true lumen (the inner space within the blood&#xD;
      vessel) by covering the proximal (nearest to the heart) tear with the stent graft. The stent&#xD;
      graft is a stent frame made from Nitinol wire and covered with an expandable material made of&#xD;
      a polyester material. This new study will determine how well the device works to treat&#xD;
      dissections, intramural hematomas, penetrating ulcers and pseudoaneurysms in the ascending&#xD;
      thoracic aorta.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study with 20 patients planned to be enrolled. Patients who participate&#xD;
      will be followed for 5 years after the surgery in which the stent graft was implanted. This&#xD;
      will include the following schedule: A CT with and without contrast and echocardiogram 30&#xD;
      days after the Medtronic device is implanted, CT with and without contrast at 6 and 12 months&#xD;
      post procedure and once a year from 2 years thru 5 years after the implant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of all cause mortality, re-interventions, surgical conversions, post-procedural strokes and ischemic or hemorrhagic events causing motoric, language or cognitive compromise</measure>
    <time_frame>Within 30 days of the index procedure</time_frame>
    <description>Mortality, re-interventions, surgical conversions and post-procedure adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A composite of successful delivery and deployment of stent graft, coverage of lesion and/or proximal entry tear, aortic remodeling based on serial imaging, rupture</measure>
    <time_frame>To 30 days</time_frame>
    <description>Successful deployment covering the entry tear, remodeling of lesion determined by serial CT scans and documentation of ruptures</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Aortic Dissection</condition>
  <condition>Intramural Hematoma</condition>
  <condition>Penetrating Ulcer</condition>
  <condition>Pseudoaneurysm</condition>
  <arm_group>
    <arm_group_label>Endovascular repair of ascending aorta</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endovascular repair with Valiant PS-IDE Stent Graft</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endovascular repair with Valiant PS-IDE Stent Graft</intervention_name>
    <description>Endovascular stent graft repair of lesions in the ascending thoracic aorta using the Medtronic Valiant PS-IDE (Physician Sponsored-Investigational Device Exemption) Stent Graft System with the Captivia Delivery System</description>
    <arm_group_label>Endovascular repair of ascending aorta</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must have a Type A thoracic aortic dissection, retrograde Type A thoracic&#xD;
             aortic dissection, intramural hematoma, penetrating ulcer or pseudoaneurysm of the&#xD;
             ascending thoracic aorta affecting the area between the Sinus of Valsalva and the&#xD;
             innominate artery orifice (with no involvement of the aortic valve) and be considered&#xD;
             candidates for endovascular repair;&#xD;
&#xD;
          -  Patient must also have at least one cm proximal and distal landing zones in the&#xD;
             ascending aorta between 28-44 mm in diameter;&#xD;
&#xD;
          -  The patient must be deemed high-risk surgical candidate according to the following&#xD;
             established criteria: ASA (American Society of Anesthesiologists) class IV.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or pediatric patients (younger than 21 years of age);&#xD;
&#xD;
          -  Patients who have a condition that threatens to infect the stent graft/aortic valve&#xD;
             prosthesis;&#xD;
&#xD;
          -  Patients with allergies to the stent graft material;&#xD;
&#xD;
          -  Patients or their legally authorized representatives who do not sign the informed&#xD;
             consent;&#xD;
&#xD;
          -  Patients with expected survival less than one year.&#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>Rodney A White, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>LA BioMedical Research Institute at Harbor-UCLA Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ali Khoynezhad, M.D. PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>LA BioMedical Research Institute at Harbor-UCLA Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rodney A White, M.D.</last_name>
    <phone>310 222-2704</phone>
    <email>rawhite@ucla.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ali Khoynezhad, M. D., PhD</last_name>
    <phone>310 423-3851</phone>
    <email>ali.khoynezhad@cshs.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Long Beach Memorial Medical Center</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rodney A White, MD</last_name>
      <phone>310-963-5230</phone>
      <email>rawhite@ucla.edu</email>
    </contact>
    <contact_backup>
      <last_name>Ali Khoynezhad, MD</last_name>
      <phone>310-498-2091</phone>
      <email>akhoynezhad@memorialcare.org</email>
    </contact_backup>
    <investigator>
      <last_name>Rodney A. White, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ali Khoynezhad, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>LAC Harbor-UCLA Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Rodney A White, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ali Khoynezhad, M.D. PhD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>August 27, 2023</last_update_submitted>
  <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center</investigator_affiliation>
    <investigator_full_name>Rodney A. White, M.D.</investigator_full_name>
    <investigator_title>Chief, Vascular Surgery</investigator_title>
  </responsible_party>
  <keyword>Lesions in the ascending thoracic aorta</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
    <mesh_term>Aneurysm, False</mesh_term>
    <mesh_term>Penetrating Atherosclerotic Ulcer</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>share data at scientific meetings and publications</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/NCT02201589
org study id: PSIDE:Ascending Thoracic Aorta
nct id: NCT02201589
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the outcome of patients with pathologies of the
      ascending thoracic aorta (diseases in the great blood vessel or artery that leads away from
      the heart) including type A aortic dissection, retrograde type A aortic dissection,
      intramural hematoma, penetrating ulcer or pseudoaneurysm who are suitable for endovascular
      (within the vessel) repair with the Medtronic Valiant PS-IDE (Physician
      Sponsored-Investigational Device Exemption) Stent Graft. Type A aortic dissection is a
      condition where blood passes through the inner lining or between the layers of the blood
      vessel from a tear in the aortic wall (dissection) in the ascending aorta; a retrograde Type
      A aortic dissection is a condition where the dissection or tear in the ascending aorta starts
      from the descending aorta; an intramural hematoma is a collection of clotted blood within the
      aortic wall; a penetrating ulcer has a plaque or clot within the wall and a pseudoaneurysm is
      a false aneurysm . If left untreated in any of these conditions, the aorta can enlarge and
      rupture causing injury or death. The plan for these patients is to repair the ascending
      thoracic aorta using the Medtronic Valiant PS-IDE Stent Graft with the Captivia Delivery
      System. The Valiant Captivia has been evaluated worldwide and used extensively in patients
      with type B (descending) thoracic aortic dissection. Since the dissections in the ascending
      aortas mirror that of the descending aorta, it is expected that this stent graft will deliver
      similar performance and endurance in patients with type A aortic dissection. The
      investigators expect to reroute the blood to the true lumen (the inner space within the blood
      vessel) by covering the proximal (nearest to the heart) tear with the stent graft. The stent
      graft is a stent frame made from Nitinol wire and covered with an expandable material made of
      a polyester material. This new study will determine how well the device works to treat
      dissections, intramural hematomas, penetrating ulcers and pseudoaneurysms in the ascending
      thoracic aorta.
This is a prospective study with 20 patients planned to be enrolled. Patients who participate
      will be followed for 5 years after the surgery in which the stent graft was implanted. This
      will include the following schedule: A CT with and without contrast and echocardiogram 30
      days after the Medtronic device is implanted, CT with and without contrast at 6 and 12 months
      post procedure and once a year from 2 years thru 5 years after the implant.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite of all cause mortality, re-interventions, surgical conversions, post-procedural strokes and ischemic or hemorrhagic events causing motoric, language or cognitive compromise
time frame: Within 30 days of the index procedure
description: Mortality, re-interventions, surgical conversions and post-procedure adverse events
measure: A composite of successful delivery and deployment of stent graft, coverage of lesion and/or proximal entry tear, aortic remodeling based on serial imaging, rupture
time frame: To 30 days
description: Successful deployment covering the entry tear, remodeling of lesion determined by serial CT scans and documentation of ruptures
arm group label: Endovascular repair of ascending aorta
arm group type: Experimental
description: Endovascular repair with Valiant PS-IDE Stent Graft
intervention type: Device
intervention name: Endovascular repair with Valiant PS-IDE Stent Graft
description: Endovascular stent graft repair of lesions in the ascending thoracic aorta using the Medtronic Valiant PS-IDE (Physician Sponsored-Investigational Device Exemption) Stent Graft System with the Captivia Delivery System
arm group label: Endovascular repair of ascending aorta
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rodney A White, M.D.
role: Principal Investigator
affiliation: LA BioMedical Research Institute at Harbor-UCLA Medical Center
last name: Ali Khoynezhad, M.D. PhD.
role: Principal Investigator
affiliation: LA BioMedical Research Institute at Harbor-UCLA Medical Center
last name: Rodney A White, M.D.
phone: 310 222-2704
email: rawhite@ucla.edu
last name: Ali Khoynezhad, M. D., PhD
phone: 310 423-3851
email: ali.khoynezhad@cshs.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Terminated
facility: 
status: Recruiting
investigator: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
investigator full name: Rodney A. White, M.D.
investigator title: Chief, Vascular Surgery
mesh term: Aortic Dissection
mesh term: Aneurysm, False
mesh term: Penetrating Atherosclerotic Ulcer
mesh term: Hematoma
sharing ipd: No
ipd description: share data at scientific meetings and publications