<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/NCT02224794</url>
  </required_header>
  <id_info>
    <org_study_id>771-0014</org_study_id>
    <nct_id>NCT02224794</nct_id>
  </id_info>
  <brief_title>LIFE Study: Least Invasive Fast-Track EVAR</brief_title>
  <official_title>LIFE Study: Least Invasive Fast-Track EVAR With the Ovation® Abdominal Stent Graft Platform</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TriVascular, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endologix</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits&#xD;
      associated with using the Ovation® Abdominal Stent Graft Platform under the least invasive&#xD;
      conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR&#xD;
      protocol include: appropriate patient selection, bilateral percutaneous access, no general&#xD;
      anesthesia, no ICU admission post procedure, and next day discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The LIFE Study is a prospective, consecutively enrolling, non-randomized multi center&#xD;
      post-market registry to evaluate the ultra low profile (14F) Ovation Abdominal Stent Graft&#xD;
      Platform when using in the Percutaneous Endovascular Aneurysm Repair (P-EVAR) treatment of&#xD;
      patients with AAA using a Fast-Track EVAR protocol.&#xD;
&#xD;
      250 study patients will be enrolled at up to 40 institutions. Follow-up period is one month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Major Adverse Events</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serious and non-serious adverse events, including vascular and major access site vascular complications</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess technical success, defined as percent of procedures successfully completed with bilateral percutaneous access</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment success, defined as percent of subjects who successfully follow least invasive protocol through discharge</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss, including if transfusion required</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of procedures completed without general anesthesia</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anesthesia time</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contrast volume</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to hemostasis</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to ambulation</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to normal diet</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Groin pain</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of subjects discharged without ICU admission</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay, if required</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of subjects discharged within only one midnight stay</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from type I and III endoleaks</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from AAA rupture</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from conversion to open repair</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from AAA related secondary interventions</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from mortality</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">250</enrollment>
  <condition>Abdominal Aortic Aneurysm</condition>
  <arm_group>
    <arm_group_label>Fast-Track Group</arm_group_label>
    <description>includes subjects who complete the Fast-Track EVAR protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard P-EVAR Group</arm_group_label>
    <description>includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are completed with bilateral percutaneous access</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard EVAR Group</arm_group_label>
    <description>includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are not completed with bilateral percutaneous access (i.e. converted to femoral cutdown or open surgical repair)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ovation® Abdominal Stent Graft Platform</intervention_name>
    <arm_group_label>Fast-Track Group</arm_group_label>
    <arm_group_label>Standard EVAR Group</arm_group_label>
    <arm_group_label>Standard P-EVAR Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will enroll male and female subjects 18 years and older that have an AAA and meet&#xD;
        all other inclusion/exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is ≥ 18 years of age.&#xD;
&#xD;
          -  Patients who are male or non-pregnant female (females of child bearing potential must&#xD;
             have a negative pregnancy test prior to enrollment into the study).&#xD;
&#xD;
          -  Patient has signed an IRB approved informed consent form.&#xD;
&#xD;
          -  Patient is considered by the treating physician to be a candidate for elective open&#xD;
             surgical repair of the AAA.&#xD;
&#xD;
          -  Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the&#xD;
             following: abdominal aortic aneurysm &gt;5.0 cm in diameter, aneurysm has increased in&#xD;
             size by 0.5 cm in last 6 months, or maximum diameter of aneurysm exceeds 1.5 times the&#xD;
             transverse dimension of an adjacent non-aneurysm exceeds 1.5 times the transverse&#xD;
             dimension of an adjacent non-aneurysmal aortic segment.&#xD;
&#xD;
          -  Patient has suitable anatomy that allows use of the TriVascular Ovation® Abdominal&#xD;
             Stent Graft Platform.&#xD;
&#xD;
          -  Patient has suitable femoral arteries at the percutaneous access site that allow use&#xD;
             of the Perclose ProGlide Suture-Mediated Closure System via the pre-close technique.&#xD;
&#xD;
          -  Patient must be willing to comply with all required follow-up exams.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has a need for emergent surgery.&#xD;
&#xD;
          -  Patient has a dissecting aneurysm.&#xD;
&#xD;
          -  Patient has an acutely ruptured aneurysm.&#xD;
&#xD;
          -  Patient has an acute vascular injury.&#xD;
&#xD;
          -  Patient has had a previous repair of the abdominal aortic aneurysm or the iliac&#xD;
             artery.&#xD;
&#xD;
          -  Patient has a mycotic aneurysm or has an active systemic infection.&#xD;
&#xD;
          -  Patient has unstable angina.&#xD;
&#xD;
          -  Patient has unstable peripheral artery disease with critical limb ischemia.&#xD;
&#xD;
          -  Patient has congestive heart failure.&#xD;
&#xD;
          -  Patient has had a myocardial infarction and/or stroke within the past 3 months.&#xD;
&#xD;
          -  Patient requires use of techniques that would cover the renal arteries.&#xD;
&#xD;
          -  Patient requires planned adjunctive devices to complete the procedure.&#xD;
&#xD;
          -  Patient has a major surgical or interventional procedure planned during or within ±30&#xD;
             days of the AAA repair.&#xD;
&#xD;
          -  Patient has history of connective tissue disease.&#xD;
&#xD;
          -  Patient has history of bleeding disorders or refuses blood transfusions.&#xD;
&#xD;
          -  Patient has dialysis dependent renal failure or baseline serum creatinine level&#xD;
             &gt;2.0mg/dl.&#xD;
&#xD;
          -  Patient has a known hypersensitivity or contraindication to anticoagulation or&#xD;
             contrast media that is not amenable to pre-treatment.&#xD;
&#xD;
          -  Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE),&#xD;
             PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol.&#xD;
&#xD;
          -  Patient is on home oxygen.&#xD;
&#xD;
          -  Patient is morbidly obese (BMI ≥40 kg/m2).&#xD;
&#xD;
          -  Patient was admitted from a skilled nursing facility.&#xD;
&#xD;
          -  Patient has a limited life expectancy of less than 1 year.&#xD;
&#xD;
          -  Patient has an inability to be discharged within 1 day of the procedure.&#xD;
&#xD;
          -  Patient is currently participating in an investigational device or drug clinical&#xD;
             trial.&#xD;
&#xD;
          -  Patient has other medical, social or psychological conditions that, in the opinion of&#xD;
             the investigator, preclude them from receiving the pre-treatment, required treatment,&#xD;
             and post-treatment procedures and evaluations.&#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>Zvonimir Krajcer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHI St. Luke's Health, Texas</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Venkatesh Ramaiah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arizona Heart Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abrazo Arizona Heart Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Episcopal Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.endologix.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>June 3, 2021</last_update_submitted>
  <last_update_submitted_qc>June 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>abdominal</keyword>
  <keyword>aortic</keyword>
  <keyword>aneurysm</keyword>
  <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>
  <!-- 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/NCT02224794
org study id: 771-0014
nct id: NCT02224794
lead sponsor: 
has dmc: No
The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits
      associated with using the Ovation® Abdominal Stent Graft Platform under the least invasive
      conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR
      protocol include: appropriate patient selection, bilateral percutaneous access, no general
      anesthesia, no ICU admission post procedure, and next day discharge.
The LIFE Study is a prospective, consecutively enrolling, non-randomized multi center
      post-market registry to evaluate the ultra low profile (14F) Ovation Abdominal Stent Graft
      Platform when using in the Percutaneous Endovascular Aneurysm Repair (P-EVAR) treatment of
      patients with AAA using a Fast-Track EVAR protocol.

      250 study patients will be enrolled at up to 40 institutions. Follow-up period is one month.
observational model: Cohort
time perspective: Prospective
measure: Major Adverse Events
time frame: 30 days
measure: Serious and non-serious adverse events, including vascular and major access site vascular complications
time frame: 30 days
measure: Assess technical success, defined as percent of procedures successfully completed with bilateral percutaneous access
time frame: 30 days
measure: Treatment success, defined as percent of subjects who successfully follow least invasive protocol through discharge
time frame: 30 days
measure: Blood loss, including if transfusion required
time frame: 30 days
measure: Percent of procedures completed without general anesthesia
time frame: 30 days
measure: Anesthesia time
time frame: 30 days
measure: Procedure time
time frame: 30 days
measure: Contrast volume
time frame: 30 days
measure: Fluoroscopy time
time frame: 30 days
measure: Time to hemostasis
time frame: 30 days
measure: Time to ambulation
time frame: 30 days
measure: Time to normal diet
time frame: 30 days
measure: Groin pain
time frame: 30 days
measure: Quality of Life
time frame: 30 days
measure: Percent of subjects discharged without ICU admission
time frame: 30 days
measure: Length of ICU stay, if required
time frame: 30 days
measure: Length of hospital stay
time frame: 30 days
measure: Percent of subjects discharged within only one midnight stay
time frame: 30 days
measure: Freedom from type I and III endoleaks
time frame: 30 days
measure: Freedom from AAA rupture
time frame: 30 days
measure: Freedom from conversion to open repair
time frame: 30 days
measure: Freedom from AAA related secondary interventions
time frame: 30 days
measure: Freedom from mortality
time frame: 30 days
arm group label: Fast-Track Group
description: includes subjects who complete the Fast-Track EVAR protocol
arm group label: Standard P-EVAR Group
description: includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are completed with bilateral percutaneous access
arm group label: Standard EVAR Group
description: includes subjects who do not complete the Fast-Track EVAR protocol, and their procedures are not completed with bilateral percutaneous access (i.e. converted to femoral cutdown or open surgical repair)
intervention type: Device
intervention name: Ovation® Abdominal Stent Graft Platform
arm group label: Fast-Track Group
arm group label: Standard EVAR Group
arm group label: Standard P-EVAR Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zvonimir Krajcer, MD
role: Principal Investigator
affiliation: CHI St. Luke's Health, Texas
last name: Venkatesh Ramaiah, MD
role: Principal Investigator
affiliation: Arizona Heart Institute
facility: 
facility: 
country: United States
url: http://www.endologix.com
description: Related Info
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal