<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/NCT03246126</url>
  </required_header>
  <id_info>
    <org_study_id>16-01441</org_study_id>
    <nct_id>NCT03246126</nct_id>
  </id_info>
  <brief_title>Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms</brief_title>
  <official_title>Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to evaluate the use of an investigational device called the&#xD;
      ValiantTM Visceral Manifold Thoracoabdominal Stent Graft System for the repair of&#xD;
      thoracoabdominal aortic aneurysms (TAAA), which is a balloon-like bulge in the aorta (major&#xD;
      artery leading away from your heart) that originates in your chest and extends to your&#xD;
      abdomen and also includes the branch arteries that supply blood to the liver, spleen,&#xD;
      intestine, kidneys and other organs in your abdomen. The word &quot;investigational&quot; means the&#xD;
      device is still being tested and is not approved by the Food and Drug Administration (FDA)&#xD;
      for sale in the United States.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the clinical investigation is to assess the use of the thoracic&#xD;
      bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients&#xD;
      having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom&#xD;
      from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment&#xD;
      success and technical success) of the device (i.e., the proportion of treatment group&#xD;
      subjects that achieve and maintain treatment success at one year). Additionally, the study&#xD;
      will assess technical success and treatment success at each follow-up interval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">January 2027</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <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>Proportion of subjects experiencing a major adverse event through 30 days</measure>
    <time_frame>30 Days</time_frame>
    <description>Proportion of the study subjects with treatment success at 1 year. The data will be presented as quality outcomes, with the number of study subjects who experience treatment success compared to the overall patient population.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Thoracoabdominal Aortic Aneurysms</condition>
  <arm_group>
    <arm_group_label>Valiant™Thoracoabdominal Stent Graft System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The implantation of the Valiant™ Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Valiant™Thoracoabdominal Stent Graft System</intervention_name>
    <description>The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.</description>
    <arm_group_label>Valiant™Thoracoabdominal Stent Graft System</arm_group_label>
    <other_name>Endurant Stent Graft System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A patient may be entered into the study if the patient has at least one of the&#xD;
             following:&#xD;
&#xD;
          -  An aneurysm with a maximum diameter of &gt; 5.5 cm or 2 times the normal diameter just&#xD;
             proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline)&#xD;
             measurements&#xD;
&#xD;
          -  Aneurysm with a history of growth &gt; 0.5 cm in 6 months&#xD;
&#xD;
          -  Saccular aneurysm deemed at significant risk for rupture&#xD;
&#xD;
          -  Symptomatic aneurysm greater than 4.5 cm&#xD;
&#xD;
          -  Axillary or brachial and iliac or femoral access vessel morphology that is compatible&#xD;
             with vascular access techniques, devices or accessories, with or without use of a&#xD;
             surgical conduit&#xD;
&#xD;
          -  Proximal landing zone for the thoracic bifurcation stent graft that has:&#xD;
&#xD;
          -  ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material&#xD;
             (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm&#xD;
&#xD;
          -  Adequate distance from the celiac artery, in order to accommodate cannulation from the&#xD;
             antegrade access point when considering the total deployed length of the thoracic&#xD;
             bifurcation and visceral manifold&#xD;
&#xD;
          -  Minimum branch vessel diameter greater than or equal to 5 mm&#xD;
&#xD;
          -  Iliac artery or aortic distal fixation site, including both native tissue and&#xD;
             previously placed graft, greater than or equal to 15 mm in length and diameter in the&#xD;
             range of 8 - 25 mm&#xD;
&#xD;
          -  Life expectancy: &gt; 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is a good candidate for and elects for open surgical repair&#xD;
&#xD;
          -  Can be treated in accordance with the instructions for use with a legally marketed&#xD;
             endovascular prosthesis&#xD;
&#xD;
          -  Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site&#xD;
&#xD;
          -  Unwilling to comply with the follow-up schedule&#xD;
&#xD;
          -  Inability or refusal to give informed consent&#xD;
&#xD;
          -  Urgent or emergent presentation&#xD;
&#xD;
          -  Patient is pregnant or breastfeeding&#xD;
&#xD;
          -  Patient has a contained rupture&#xD;
&#xD;
          -  Patient has a ruptured aneurysm&#xD;
&#xD;
          -  Patient has a dissection in the portion of the aorta intended to be treated&#xD;
&#xD;
          -  Obstructive stenting of any or all of the visceral vessels&#xD;
&#xD;
          -  Poor performance status including two major system failures (cardiovascular,&#xD;
             pulmonary, renal, hepatobiliary, and neuromuscular)&#xD;
&#xD;
        Medical exclusion criteria&#xD;
&#xD;
          -  Known sensitivities or allergies to the materials of construction of the devices,&#xD;
             including nitinol (Nickel: Titanium), polyester, platinum-iridium,&#xD;
             polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.&#xD;
&#xD;
          -  Known hypersensitivity or contraindication to anticoagulation or contrast media that&#xD;
             cannot be adequately medically managed&#xD;
&#xD;
          -  Uncorrectable coagulopathy&#xD;
&#xD;
          -  Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe&#xD;
             capacity of the equipment&#xD;
&#xD;
          -  Patient has had a major surgical or interventional procedure unrelated to the&#xD;
             treatment of the aneurysm planned &lt; 30 days of the endovascular repair&#xD;
&#xD;
          -  Unstable angina (defined as angina with a progressive increase in symptoms, new onset&#xD;
             at rest or nocturnal angina)&#xD;
&#xD;
          -  Systemic or local infection that may increase the risk of endovascular graft infection&#xD;
&#xD;
          -  Baseline creatinine greater than 2.0 mg/dL&#xD;
&#xD;
          -  History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos&#xD;
             Syndrome)&#xD;
&#xD;
        Anatomical exclusion criteria&#xD;
&#xD;
          -  Thrombus or excessive calcification within the neck of the aneurysm&#xD;
&#xD;
          -  Anatomy that would not allow maintenance of at least one patent hypogastric artery&#xD;
&#xD;
          -  Anatomy that would not allow primary or assisted patency of the left subclavian artery&#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>Thomas Maldonado</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 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 Aneurysm, Thoracoabdominal</mesh_term>
    <mesh_term>Aortic Aneurysm, Thoracic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03246126
org study id: 16-01441
nct id: NCT03246126
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to evaluate the use of an investigational device called the
      ValiantTM Visceral Manifold Thoracoabdominal Stent Graft System for the repair of
      thoracoabdominal aortic aneurysms (TAAA), which is a balloon-like bulge in the aorta (major
      artery leading away from your heart) that originates in your chest and extends to your
      abdomen and also includes the branch arteries that supply blood to the liver, spleen,
      intestine, kidneys and other organs in your abdomen. The word "investigational" means the
      device is still being tested and is not approved by the Food and Drug Administration (FDA)
      for sale in the United States.
The primary objective of the clinical investigation is to assess the use of the thoracic
      bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients
      having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom
      from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment
      success and technical success) of the device (i.e., the proportion of treatment group
      subjects that achieve and maintain treatment success at one year). Additionally, the study
      will assess technical success and treatment success at each follow-up interval.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of subjects experiencing a major adverse event through 30 days
time frame: 30 Days
description: Proportion of the study subjects with treatment success at 1 year. The data will be presented as quality outcomes, with the number of study subjects who experience treatment success compared to the overall patient population.
arm group label: Valiant™Thoracoabdominal Stent Graft System
arm group type: Experimental
description: The implantation of the Valiant™ Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance
intervention type: Device
intervention name: Valiant™Thoracoabdominal Stent Graft System
description: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
arm group label: Valiant™Thoracoabdominal Stent Graft System
other name: Endurant Stent Graft System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Maldonado
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Thoracoabdominal
mesh term: Aortic Aneurysm, Thoracic
sharing ipd: Undecided