<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/NCT01664078</url>
  </required_header>
  <id_info>
    <org_study_id>P11-4601</org_study_id>
    <nct_id>NCT01664078</nct_id>
  </id_info>
  <brief_title>A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)</brief_title>
  <acronym>INSPIRATION</acronym>
  <official_title>A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cordis Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carelon Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Quintiles, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cordis Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects&#xD;
      with abdominal aortic aneurysms requiring endovascular repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the US, abdominal aortic aneurysms (AAA) are found in 4-8% of older men and 0.5-1.5% of&#xD;
      older women, resulting in 30,000-40,000 elective procedures and 1,400 peri-operative deaths.&#xD;
      The most significant complication of AAA is an aneurysm sac rupture from which more than&#xD;
      15,000 patients die annually and is the 15th leading cause of death in elderly between 60 to&#xD;
      85 years of age . In Japan, it is estimated that approximately 14,000 endovascular aneurysm&#xD;
      repair (EVAR) and open surgical repair cases were performed in the year 2010 .&#xD;
&#xD;
      Abdominal aortic aneurysms can be treated three ways: (1) Medical management; (2) Open&#xD;
      surgical repair; and (3) Endovascular aneurysm repair (EVAR). EVAR has emerged as an&#xD;
      alternative treatment of AAA for most patients. It is less invasive than open repair and&#xD;
      carries lower rates of early mortality and morbidity . It has also extended treatment options&#xD;
      to patients who cannot undergo conventional surgical procedures due to a high operative risk.&#xD;
      As EVAR technology evolves, it allows treatment of AAA with increasing complexity of the&#xD;
      aortic neck and access vessels.&#xD;
&#xD;
      The InCraft® AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs&#xD;
      with complex aortic anatomies. This stent-graft system utilizes nitinol stent and polyester&#xD;
      graft technology in an ultra-low profile delivery system, which assists the physician in&#xD;
      deploying the device in a controlled, consistent, and precise manner within the aortic neck&#xD;
      and iliac arteries. By isolating the aneurysmal sac, the system provides an alternative blood&#xD;
      flow path to relieve pressure on the arterial vessel walls and minimize aneurysm growth and&#xD;
      the potential for aneurysm sac rupture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">October 10, 2018</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</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>Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate</measure>
    <time_frame>30 days post-procedure</time_frame>
    <description>defined as a composite of:&#xD;
Death&#xD;
Stroke&#xD;
Myocardial Infarction&#xD;
New Onset Renal Failure (requiring dialysis)&#xD;
Respiratory Failure (requires mechanical ventilation)&#xD;
Paralysis/paraparesis&#xD;
Bowel ischemia (requiring surgical intervention)&#xD;
Procedural blood loss ≥1,000 cc</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Successful Aneurysm Treatment</measure>
    <time_frame>Up to 1 year post-procedure</time_frame>
    <description>Successful aneurysm treatment which is a composite endpoint of the following:&#xD;
Technical Success at the conclusion of the index procedure, defined as successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location. The endovascular graft must be patent, with absence of types I or III endoleaks or aneurysm sac rupture, at the time of procedure completion as confirmed by angiography or other imaging modality;&#xD;
Absence of post-operative aneurysm enlargement (growth &gt; 5 mm) or stent graft migration (&gt; 10mm) compared to the one month size measurement at anytime up to 1-year;&#xD;
Absence of post-operative conversion to open surgery, sac rupture, endoleak Type I / III, or graft occlusion (including unilateral or bilateral limb occlusion) at any time up to 1-year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure-related Complications</measure>
    <time_frame>Through 1 month, 180-days, 360-days and annually to 5-years post-procedure</time_frame>
    <description>Adverse events that are a result of the procedure itself.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm-related Mortality</measure>
    <time_frame>At 30-days, 180-days, 360-days and annually to 5-years post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Secondary Interventions</measure>
    <time_frame>through 5 years</time_frame>
    <description>The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth &gt; 5 mm), stent graft migration (&gt; 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Events (MAEs) and Individual Components of the MAEs</measure>
    <time_frame>At 180-days, 360-days and annually to 5-years post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device-related Events</measure>
    <time_frame>At 1 month, 6 months, 1 year and annually to 5-years post-procedure</time_frame>
    <description>Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft &gt;10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter &gt; 5mm compared to the 1-month measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical Success Confirmed by CT or Other Imaging Modality</measure>
    <time_frame>At 30-days</time_frame>
    <description>The study evaluated technical success at 30-days as one of the secondary effectiveness endpoints. The definition of technical success is defined as patency of the endovascular graft, with the absence of Type I or III endoleaks or aneurysm sac rupture, up to 30-days post-procedure completion as confirmed by CT or other imaging modality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay (Days) Post Index Procedure</measure>
    <time_frame>up to 17 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure</measure>
    <time_frame>up to 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of the Index Procedure (Minutes)</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain Post-Operatively</measure>
    <time_frame>Baseline, 1 month, 6 months and 1 year post-procedure</time_frame>
    <description>Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical Functioning Post-operatively</measure>
    <time_frame>Screening, 1 month, 6 months and 1 year post-procedure</time_frame>
    <description>Physical Functioning (PF) Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">190</enrollment>
  <condition>Abdominal Aortic Aneurysm</condition>
  <arm_group>
    <arm_group_label>InCraft® - AAA stent graft system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Endovascular AAA repair using the InCraft device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endovascular AAA repair with InCraft®</intervention_name>
    <arm_group_label>InCraft® - AAA stent graft system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must meet ALL of the following inclusion criteria to be enrolled in the study:&#xD;
&#xD;
               1. Male or Female age 20 years or older;&#xD;
&#xD;
               2. Proximal aortic neck is 17-31mm in diameter;&#xD;
&#xD;
               3. Supra-renal aorta, at 20mm above the anticipated landing location, is smaller&#xD;
                  than the nominal diameter of the aortic bifurcate prosthesis to be used;&#xD;
&#xD;
               4. Infra-renal aortic neck is ≥10mm in length with supra-renal and infra-renal&#xD;
                  angulations ≤60°;&#xD;
&#xD;
               5. Subject has at least one of the following:&#xD;
&#xD;
                    1. AAA size &gt; 5.0 cm;&#xD;
&#xD;
                    2. Increase of the AAA diameter of &gt; 0.5 cm over the last 6 months;&#xD;
&#xD;
               6. Abdominal treatment length (lowest renal artery origin to the aortic bifurcation)&#xD;
                  ≥ 9.4cm;&#xD;
&#xD;
               7. Aortic bifurcation &gt;18mm in diameter;&#xD;
&#xD;
               8. Iliac landing zone ≥15mm in length;&#xD;
&#xD;
               9. Iliac landing zone 7-22mm in diameter;&#xD;
&#xD;
              10. Minimum access vessel size of ≥ 5mm;&#xD;
&#xD;
              11. Minimum overall AAA treatment length (from lowest renal artery to distal landing&#xD;
                  zone) of 128 mm;&#xD;
&#xD;
              12. Women of child bearing potential must be non-pregnant, non-lactating, and not&#xD;
                  planning to become pregnant during the course of the trial; and have a negative&#xD;
                  urine or serum pregnancy test within 7 days prior to index procedure;&#xD;
&#xD;
              13. Provide written informed consent and as applicable written HIPAA authorization&#xD;
                  (For US sites only) prior to initiation of study procedures;&#xD;
&#xD;
              14. Willing to comply with the specified follow-up evaluation schedule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will be excluded if ANY of the following exclusion criteria apply:&#xD;
&#xD;
               1. Vascular anatomy in which the placement of the stent-graft will cause occlusion&#xD;
                  of both internal iliac arteries or necessitates surgical occlusion of both&#xD;
                  internal iliac arteries;&#xD;
&#xD;
               2. Subject has one of the following:&#xD;
&#xD;
                    1. Aneurysm sac rupture or leaking abdominal aortic aneurysm;&#xD;
&#xD;
                    2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm;&#xD;
&#xD;
                    3. Clinically significant acute vascular injury due to trauma;&#xD;
&#xD;
               3. Significant aortic or iliac mural thrombus, plaque or calcification that would&#xD;
                  compromise fixation and seal of the device;&#xD;
&#xD;
               4. A conical aortic neck defined as &gt;3mm distal increase over a 10mm length in the&#xD;
                  planned seal zone;&#xD;
&#xD;
               5. Thoracic aortic aneurysm ≥45mm;&#xD;
&#xD;
               6. Any aortic dissection;&#xD;
&#xD;
               7. Morbid obesity (BMI &gt;40.0 kg.m2) or other clinical conditions that limit required&#xD;
                  imaging studies or visualization of the aorta;&#xD;
&#xD;
               8. Renal insufficiency (Creatinine &gt; 2.0mg/dL) or subject on renal dialysis;&#xD;
&#xD;
               9. Known allergy or intolerance to nickel titanium (nitinol) , Polyethylene&#xD;
                  terephthalate (PET), or polytetrafluoroethylene (PTFE);&#xD;
&#xD;
              10. Known contraindication to undergoing angiography or anticoagulation (e.g.&#xD;
                  contrast allergies which cannot be treated);&#xD;
&#xD;
              11. Connective tissue disorder (such as Marfan's Syndrome or Ehlers-Danlos Syndrome);&#xD;
&#xD;
              12. Coagulopathy, bleeding disorder, or other hypercoagulable state;&#xD;
&#xD;
              13. Organ transplant recipient or subject requiring systemic immunosuppressant&#xD;
                  therapy;&#xD;
&#xD;
              14. Cerebral vascular accident (CVA), MI, or intracranial bleeding within 3 months&#xD;
                  prior to the procedure;&#xD;
&#xD;
              15. Active infection or chronic systemic illness at the time of index procedure that&#xD;
                  may interfere with the study objectives;&#xD;
&#xD;
              16. Major surgical procedure within 1 month prior to the index procedure or&#xD;
                  pre-planned within 1 month afterwards;&#xD;
&#xD;
              17. Co-existing condition with a life expectancy of less than 2 years at time of&#xD;
                  procedure;&#xD;
&#xD;
              18. Current or planned participation in any other investigational drug or medical&#xD;
                  device clinical study that has not completed primary endpoint(s) evaluation;&#xD;
&#xD;
              19. Existing AAA surgical graft and/or a AAA stent-graft system;&#xD;
&#xD;
              20. Other medical, social, or psychological issues that in the opinion of the&#xD;
                  investigator preclude the subjects from receiving this treatment, and the&#xD;
                  procedures and evaluations pre- and posttreatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michel S Makaroun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Takao Ohki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jikei University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Michel S. Makaroun, MD</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takao Ohki, MD</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <zip>105-8461</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>April 18, 2019</results_first_submitted>
  <results_first_submitted_qc>August 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 10, 2020</results_first_posted>
  <disposition_first_submitted>June 8, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>June 30, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 5, 2017</disposition_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Abdominal Aortic 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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>InCraft® - AAA Stent Graft System</title>
          <description>Intervention: Endovascular AAA repair using the InCraft device&#xD;
Endovascular AAA repair with InCraft®</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="190"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="121"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>missed 5 year visit</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>InCraft® - AAA Stent Graft System</title>
          <description>Intervention: Endovascular AAA repair using the InCraft device&#xD;
Endovascular AAA repair with InCraft®</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="190"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Analysis was split between male and female measurements.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.6" spread="7.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.3" spread="7.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate</title>
        <description>defined as a composite of:&#xD;
Death&#xD;
Stroke&#xD;
Myocardial Infarction&#xD;
New Onset Renal Failure (requiring dialysis)&#xD;
Respiratory Failure (requires mechanical ventilation)&#xD;
Paralysis/paraparesis&#xD;
Bowel ischemia (requiring surgical intervention)&#xD;
Procedural blood loss ≥1,000 cc</description>
        <time_frame>30 days post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>InCraft® - AAA Stent Graft System</title>
            <description>Intervention: Endovascular AAA repair using the InCraft device&#xD;
Endovascular AAA repair with InCraft®</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate</title>
          <description>defined as a composite of:&#xD;
Death&#xD;
Stroke&#xD;
Myocardial Infarction&#xD;
New Onset Renal Failure (requiring dialysis)&#xD;
Respiratory Failure (requires mechanical ventilation)&#xD;
Paralysis/paraparesis&#xD;
Bowel ischemia (requiring surgical intervention)&#xD;
Procedural blood loss ≥1,000 cc</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The Intent-to-Treat (ITT) analysis set includes all subjects who had the aortic bifurcate device introduced into the body. This ITT analysis set will be used for all safety and clinical assessment endpoints.</non_inferiority_desc>
            <p_value>0.47</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Successful Aneurysm Treatment</title>
        <description>Successful aneurysm treatment which is a composite endpoint of the following:&#xD;
Technical Success at the conclusion of the index procedure, defined as successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location. The endovascular graft must be patent, with absence of types I or III endoleaks or aneurysm sac rupture, at the time of procedure completion as confirmed by angiography or other imaging modality;&#xD;
Absence of post-operative aneurysm enlargement (growth &gt; 5 mm) or stent graft migration (&gt; 10mm) compared to the one month size measurement at anytime up to 1-year;&#xD;
Absence of post-operative conversion to open surgery, sac rupture, endoleak Type I / III, or graft occlusion (including unilateral or bilateral limb occlusion) at any time up to 1-year.</description>
        <time_frame>Up to 1 year post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>InCraft® - AAA Stent Graft System</title>
            <description>Intervention: Endovascular AAA repair using the InCraft device&#xD;
Endovascular AAA repair with InCraft®</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Successful Aneurysm Treatment</title>
          <description>Successful aneurysm treatment which is a composite endpoint of the following:&#xD;
Technical Success at the conclusion of the index procedure, defined as successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location. The endovascular graft must be patent, with absence of types I or III endoleaks or aneurysm sac rupture, at the time of procedure completion as confirmed by angiography or other imaging modality;&#xD;
Absence of post-operative aneurysm enlargement (growth &gt; 5 mm) or stent graft migration (&gt; 10mm) compared to the one month size measurement at anytime up to 1-year;&#xD;
Absence of post-operative conversion to open surgery, sac rupture, endoleak Type I / III, or graft occlusion (including unilateral or bilateral limb occlusion) at any time up to 1-year.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure-related Complications</title>
        <description>Adverse events that are a result of the procedure itself.</description>
        <time_frame>Through 1 month, 180-days, 360-days and annually to 5-years post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Site-reported Procedure-related AEs Through 1 Month</title>
            <description>procedure-related complications were tabulated as secondary safety endpoints</description>
          </group>
          <group group_id="O2">
            <title>Site-reported Procedure-related AEs Through 180 Days</title>
            <description>procedure-related complications were tabulated as secondary safety endpoints</description>
          </group>
          <group group_id="O3">
            <title>Site-reported Procedure-related AEs Through 360 Days</title>
            <description>procedure-related complications were tabulated as secondary safety endpoints</description>
          </group>
          <group group_id="O4">
            <title>Site-reported Procedure-related AEs Through 2 Years</title>
            <description>procedure-related complications were tabulated as secondary safety endpoints</description>
          </group>
          <group group_id="O5">
            <title>Site-reported Procedure-related AEs Through 3 Years</title>
            <description>procedure-related complications were tabulated as secondary safety endpoints</description>
          </group>
          <group group_id="O6">
            <title>Site-reported Procedure-related AEs Through 4 Years</title>
            <description>procedure-related complications were tabulated as secondary safety endpoints</description>
          </group>
          <group group_id="O7">
            <title>Site-reported Procedure-related AEs Through 5 Years</title>
            <description>procedure-related complications were tabulated as secondary safety endpoints</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure-related Complications</title>
          <description>Adverse events that are a result of the procedure itself.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
                <count group_id="O2" value="189"/>
                <count group_id="O3" value="188"/>
                <count group_id="O4" value="186"/>
                <count group_id="O5" value="185"/>
                <count group_id="O6" value="185"/>
                <count group_id="O7" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="104"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="109"/>
                    <measurement group_id="O6" value="112"/>
                    <measurement group_id="O7" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aneurysm-related Mortality</title>
        <time_frame>At 30-days, 180-days, 360-days and annually to 5-years post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Aneurysm-related Morality Through 1 Month</title>
            <description>Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.</description>
          </group>
          <group group_id="O2">
            <title>Aneurysm-related Morality Through 180 Days</title>
            <description>Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.</description>
          </group>
          <group group_id="O3">
            <title>Aneurysm-related Morality Through 360 Days</title>
            <description>Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.</description>
          </group>
          <group group_id="O4">
            <title>Aneurysm-related Morality Through 2 Years</title>
            <description>Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.</description>
          </group>
          <group group_id="O5">
            <title>Aneurysm-related Morality Through 3 Years</title>
            <description>Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.</description>
          </group>
          <group group_id="O6">
            <title>Aneurysm-related Morality Through 4 Years</title>
            <description>Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.</description>
          </group>
          <group group_id="O7">
            <title>Aneurysm-related Morality Through 5 Years</title>
            <description>Aneurysm-related mortality is defined as death from AAA rupture, or death within 30 days of open aortic surgical or endovascular repair, or death from any subsequent procedure required to treat the same aneurysm.</description>
          </group>
        </group_list>
        <measure>
          <title>Aneurysm-related Mortality</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
                <count group_id="O2" value="187"/>
                <count group_id="O3" value="183"/>
                <count group_id="O4" value="176"/>
                <count group_id="O5" value="172"/>
                <count group_id="O6" value="168"/>
                <count group_id="O7" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Secondary Interventions</title>
        <description>The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth &gt; 5 mm), stent graft migration (&gt; 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.</description>
        <time_frame>through 5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Secondary Intervention Through 1 Month</title>
            <description>The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth &gt; 5 mm), stent graft migration (&gt; 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.</description>
          </group>
          <group group_id="O2">
            <title>Secondary Intervention Through 180 Days</title>
            <description>The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth &gt; 5 mm), stent graft migration (&gt; 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.</description>
          </group>
          <group group_id="O3">
            <title>Secondary Intervention Through 360 Days</title>
            <description>The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth &gt; 5 mm), stent graft migration (&gt; 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.</description>
          </group>
          <group group_id="O4">
            <title>Secondary Intervention Through 2 Years</title>
            <description>The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth &gt; 5 mm), stent graft migration (&gt; 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.</description>
          </group>
          <group group_id="O5">
            <title>Secondary Intervention Through 3 Years</title>
            <description>The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth &gt; 5 mm), stent graft migration (&gt; 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.</description>
          </group>
          <group group_id="O6">
            <title>Secondary Intervention Through 4 Years</title>
            <description>The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth &gt; 5 mm), stent graft migration (&gt; 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.</description>
          </group>
          <group group_id="O7">
            <title>Secondary Intervention Through 5 Years</title>
            <description>The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth &gt; 5 mm), stent graft migration (&gt; 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Secondary Interventions</title>
          <description>The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth &gt; 5 mm), stent graft migration (&gt; 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="189"/>
                <count group_id="O2" value="183"/>
                <count group_id="O3" value="176"/>
                <count group_id="O4" value="162"/>
                <count group_id="O5" value="149"/>
                <count group_id="O6" value="132"/>
                <count group_id="O7" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="12"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Adverse Events (MAEs) and Individual Components of the MAEs</title>
        <time_frame>At 180-days, 360-days and annually to 5-years post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MAEs Through 180 Days</title>
            <description>All MAEs are site-reported then adjudicated by the CEC.</description>
          </group>
          <group group_id="O2">
            <title>MAEs Through 360 Days</title>
            <description>All MAEs are site-reported then adjudicated by the CEC.</description>
          </group>
          <group group_id="O3">
            <title>MAEs Through 2 Years</title>
            <description>All MAEs are site-reported then adjudicated by the CEC.</description>
          </group>
          <group group_id="O4">
            <title>MAEs Through 3 Years</title>
            <description>All MAEs are site-reported then adjudicated by the CEC.</description>
          </group>
          <group group_id="O5">
            <title>MAEs Through 4 Years</title>
            <description>All MAEs are site-reported then adjudicated by the CEC.</description>
          </group>
          <group group_id="O6">
            <title>MAEs Through 5 Years</title>
            <description>All MAEs are site-reported then adjudicated by the CEC.</description>
          </group>
        </group_list>
        <measure>
          <title>Major Adverse Events (MAEs) and Individual Components of the MAEs</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="187"/>
                <count group_id="O2" value="183"/>
                <count group_id="O3" value="176"/>
                <count group_id="O4" value="172"/>
                <count group_id="O5" value="168"/>
                <count group_id="O6" value="165"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="22"/>
                    <measurement group_id="O5" value="35"/>
                    <measurement group_id="O6" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myocardial infarction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="12"/>
                    <measurement group_id="O6" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New onset renal failure (requiring dialysis)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory failure (requiring mechanical ventilat</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paralysis / paraparesis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bowel ischemia (requiring surgical intervention)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Procedural blood loss (≥1,000 cc)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Device-related Events</title>
        <description>Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft &gt;10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter &gt; 5mm compared to the 1-month measurement.</description>
        <time_frame>At 1 month, 6 months, 1 year and annually to 5-years post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Device-related Events Through 1 Month</title>
            <description>Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft &gt;10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter &gt; 5mm compared to the 1-month measurement.</description>
          </group>
          <group group_id="O2">
            <title>Device-related Events Through 180 Days</title>
            <description>Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft &gt;10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter &gt; 5mm compared to the 1-month measurement.</description>
          </group>
          <group group_id="O3">
            <title>Device-related Events Through 360 Days</title>
            <description>Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft &gt;10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter &gt; 5mm compared to the 1-month measurement.</description>
          </group>
          <group group_id="O4">
            <title>Device-related Events Through 2 Years</title>
            <description>Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft &gt;10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter &gt; 5mm compared to the 1-month measurement.</description>
          </group>
          <group group_id="O5">
            <title>Device-related Events Through 3 Years</title>
            <description>Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft &gt;10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter &gt; 5mm compared to the 1-month measurement.</description>
          </group>
          <group group_id="O6">
            <title>Device-related Events Through 4 Years</title>
            <description>Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft &gt;10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter &gt; 5mm compared to the 1-month measurement.</description>
          </group>
          <group group_id="O7">
            <title>Device-related Events Through 5 Years</title>
            <description>Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft &gt;10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter &gt; 5mm compared to the 1-month measurement.</description>
          </group>
        </group_list>
        <measure>
          <title>Device-related Events</title>
          <description>Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft &gt;10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter &gt; 5mm compared to the 1-month measurement.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="181"/>
                <count group_id="O2" value="167"/>
                <count group_id="O3" value="159"/>
                <count group_id="O4" value="141"/>
                <count group_id="O5" value="131"/>
                <count group_id="O6" value="115"/>
                <count group_id="O7" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="24"/>
                    <measurement group_id="O5" value="40"/>
                    <measurement group_id="O6" value="42"/>
                    <measurement group_id="O7" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Technical Success Confirmed by CT or Other Imaging Modality</title>
        <description>The study evaluated technical success at 30-days as one of the secondary effectiveness endpoints. The definition of technical success is defined as patency of the endovascular graft, with the absence of Type I or III endoleaks or aneurysm sac rupture, up to 30-days post-procedure completion as confirmed by CT or other imaging modality.</description>
        <time_frame>At 30-days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Technical Success</title>
            <description>Technical success confirmed by CT or other imaging modality</description>
          </group>
        </group_list>
        <measure>
          <title>Technical Success Confirmed by CT or Other Imaging Modality</title>
          <description>The study evaluated technical success at 30-days as one of the secondary effectiveness endpoints. The definition of technical success is defined as patency of the endovascular graft, with the absence of Type I or III endoleaks or aneurysm sac rupture, up to 30-days post-procedure completion as confirmed by CT or other imaging modality.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay (Days) Post Index Procedure</title>
        <time_frame>up to 17 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Length of Hospital Stay (Days) Post Index Procedure</title>
            <description>Length of hospital stay (days) post index procedure as part of the clinical utility measure</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay (Days) Post Index Procedure</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="2.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure</title>
        <time_frame>up to 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Length of Intensive Care Unit (ICU) Stay (Hours) Post Index pr</title>
            <description>Length of Intensive Care Unit (ICU) stay (hours) post index pr as part of the clinical utility measure</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure</title>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="0" upper_limit="18.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of the Index Procedure (Minutes)</title>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Length of the Index Procedure (Minutes)</title>
            <description>Length of the Index Procedure (Minutes) as part of the clinical utility measure</description>
          </group>
        </group_list>
        <measure>
          <title>Length of the Index Procedure (Minutes)</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.7" lower_limit="58.83" upper_limit="146.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pain Post-Operatively</title>
        <description>Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.</description>
        <time_frame>Baseline, 1 month, 6 months and 1 year post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pain Post-Operatively at Baseline</title>
            <description>Pain post-operatively as measured by the SF36v2 (bodily pain BP) at screening, 1-month, 6-months, and 1-year follow-up</description>
          </group>
          <group group_id="O2">
            <title>Pain Post-Operatively at 1-Month</title>
            <description>Pain post-operatively were compared to baseline values, as measured by the SF36v2 (bodily pain BP) at screening, 1-month, 6-months, and 1-year follow-up</description>
          </group>
          <group group_id="O3">
            <title>Pain Post-Operatively at 6-Months</title>
            <description>Pain post-operatively were compared to baseline values, as measured by the SF36v2 (bodily pain BP) at screening, 1-month, 6-months, and 1-year follow-up</description>
          </group>
          <group group_id="O4">
            <title>Pain Post-Operatively at 1-Year</title>
            <description>Pain post-operatively were compared to baseline values, as measured by the SF36v2 (bodily pain BP) at screening, 1-month, 6-months, and 1-year follow-up</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Post-Operatively</title>
          <description>Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.</description>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="187"/>
                <count group_id="O2" value="188"/>
                <count group_id="O3" value="179"/>
                <count group_id="O4" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.4" lower_limit="45.18" upper_limit="97.62"/>
                    <measurement group_id="O2" value="70.2" lower_limit="44.7" upper_limit="95.7"/>
                    <measurement group_id="O3" value="71.5" lower_limit="43.9" upper_limit="99.1"/>
                    <measurement group_id="O4" value="73.1" lower_limit="47.68" upper_limit="98.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Physical Functioning Post-operatively</title>
        <description>Physical Functioning (PF) Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.</description>
        <time_frame>Screening, 1 month, 6 months and 1 year post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Physical Functioning Post-operatively at Baseline</title>
            <description>Physical functioning post-operatively as measured by the SF36v2 [physical component summary (PCS), physical functioning (PF) and role physical (RP) domains] at screening, 1-month, 6-months, and 1-year follow up</description>
          </group>
          <group group_id="O2">
            <title>Physical Functioning Post-operatively at 1 Month</title>
            <description>Physical functioning post-operatively as measured by the SF36v2 [physical component summary (PCS), physical functioning (PF) and role physical (RP) domains] at screening, 1-month, 6-months, and 1-year follow up</description>
          </group>
          <group group_id="O3">
            <title>Physical Functioning Post-operatively at 6 Month</title>
            <description>Physical functioning post-operatively as measured by the SF36v2 [physical component summary (PCS), physical functioning (PF) and role physical (RP) domains] at screening, 1-month, 6-months, and 1-year follow up</description>
          </group>
          <group group_id="O4">
            <title>Physical Functioning Post-operatively at 1 Year</title>
            <description>Physical functioning post-operatively as measured by the SF36v2 [physical component summary (PCS), physical functioning (PF) and role physical (RP) domains] at screening, 1-month, 6-months, and 1-year follow up</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Functioning Post-operatively</title>
          <description>Physical Functioning (PF) Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.</description>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="188"/>
                <count group_id="O2" value="188"/>
                <count group_id="O3" value="179"/>
                <count group_id="O4" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2" lower_limit="42.96" upper_limit="95.44"/>
                    <measurement group_id="O2" value="66.5" lower_limit="38.93" upper_limit="94.07"/>
                    <measurement group_id="O3" value="68.6" lower_limit="41.43" upper_limit="95.77"/>
                    <measurement group_id="O4" value="68.2" lower_limit="41.49" upper_limit="94.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from index procedure until completion of study or early termination.</time_frame>
      <desc>All-Cause Mortality, Serious Adverse Events, Other (Not Including Serious) Adverse Events.</desc>
      <group_list>
        <group group_id="E1">
          <title>InCraft</title>
          <description>Infrarenal Abdominal Aortic Aneurysm Stent Graft System</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="188"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Blood and Lymphatic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac disorders</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Congenital disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General disorders and administration site conditions</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury, poisoning and procedural complications2</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Investigations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolisms and Nutrition Disorders</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified (including cysts and polyps)</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system disorders</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal and urinary disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgical and medical procedures</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular disorders</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="93" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General disorders and administration site conditions</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury, poisoning and procedural complications1</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorders</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system disorders</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal and urinary disorders</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular disorders4</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="188"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Number of participants at risk my vary depending on varying windows used for analysis, imaging availability, visits completed and will therefore not be consistent throughout report.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Brandy Maschhaupt</name_or_title>
      <organization>Cordis, a Cardinal Health Company</organization>
      <phone>847 887 5744</phone>
      <email>brandy.maschhaupt@cardinalhealth.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01664078
org study id: P11-4601
nct id: NCT01664078
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects
      with abdominal aortic aneurysms requiring endovascular repair.
In the US, abdominal aortic aneurysms (AAA) are found in 4-8% of older men and 0.5-1.5% of
      older women, resulting in 30,000-40,000 elective procedures and 1,400 peri-operative deaths.
      The most significant complication of AAA is an aneurysm sac rupture from which more than
      15,000 patients die annually and is the 15th leading cause of death in elderly between 60 to
      85 years of age . In Japan, it is estimated that approximately 14,000 endovascular aneurysm
      repair (EVAR) and open surgical repair cases were performed in the year 2010 .

      Abdominal aortic aneurysms can be treated three ways: (1) Medical management; (2) Open
      surgical repair; and (3) Endovascular aneurysm repair (EVAR). EVAR has emerged as an
      alternative treatment of AAA for most patients. It is less invasive than open repair and
      carries lower rates of early mortality and morbidity . It has also extended treatment options
      to patients who cannot undergo conventional surgical procedures due to a high operative risk.
      As EVAR technology evolves, it allows treatment of AAA with increasing complexity of the
      aortic neck and access vessels.

      The InCraft® AAA Stent Graft System is designed for endovascular repair of infrarenal AAAs
      with complex aortic anatomies. This stent-graft system utilizes nitinol stent and polyester
      graft technology in an ultra-low profile delivery system, which assists the physician in
      deploying the device in a controlled, consistent, and precise manner within the aortic neck
      and iliac arteries. By isolating the aneurysmal sac, the system provides an alternative blood
      flow path to relieve pressure on the arterial vessel walls and minimize aneurysm growth and
      the potential for aneurysm sac rupture.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Incidence of MAE (Major Adverse Events) Based Upon a Composite MAE Rate
time frame: 30 days post-procedure
description: defined as a composite of:
Death
Stroke
Myocardial Infarction
New Onset Renal Failure (requiring dialysis)
Respiratory Failure (requires mechanical ventilation)
Paralysis/paraparesis
Bowel ischemia (requiring surgical intervention)
Procedural blood loss ≥1,000 cc
measure: Number of Participants With Successful Aneurysm Treatment
time frame: Up to 1 year post-procedure
description: Successful aneurysm treatment which is a composite endpoint of the following:
Technical Success at the conclusion of the index procedure, defined as successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location. The endovascular graft must be patent, with absence of types I or III endoleaks or aneurysm sac rupture, at the time of procedure completion as confirmed by angiography or other imaging modality;
Absence of post-operative aneurysm enlargement (growth > 5 mm) or stent graft migration (> 10mm) compared to the one month size measurement at anytime up to 1-year;
Absence of post-operative conversion to open surgery, sac rupture, endoleak Type I / III, or graft occlusion (including unilateral or bilateral limb occlusion) at any time up to 1-year.
measure: Procedure-related Complications
time frame: Through 1 month, 180-days, 360-days and annually to 5-years post-procedure
description: Adverse events that are a result of the procedure itself.
measure: Aneurysm-related Mortality
time frame: At 30-days, 180-days, 360-days and annually to 5-years post-procedure
measure: Incidence of Secondary Interventions
time frame: through 5 years
description: The incidence of secondary interventions within 1 year post-procedure, needed to prevent the occurrence of a significant event. Significant event being defined as: aneurysm enlargement (growth > 5 mm), stent graft migration (> 10mm) compared to the one month size, endoleak type I / III, graft occlusion, sac rupture.
measure: Major Adverse Events (MAEs) and Individual Components of the MAEs
time frame: At 180-days, 360-days and annually to 5-years post-procedure
measure: Device-related Events
time frame: At 1 month, 6 months, 1 year and annually to 5-years post-procedure
description: Endoleak(s), Aneurysm sac rupture, Fracture(s, Delivery System Malfunction, Device Malfunction, Stent Graft Migration - evidence of proximal or distal movement of the stent graft >10mm relative to fixed anatomic landmarks compared with 1 month, Graft Occlusion (including unilateral or bilateral limb occlusion, Conversion to open surgery, and Aneurysm Enlargement - defined as an increase in maximum aneurysm cross sectional diameter > 5mm compared to the 1-month measurement.
measure: Technical Success Confirmed by CT or Other Imaging Modality
time frame: At 30-days
description: The study evaluated technical success at 30-days as one of the secondary effectiveness endpoints. The definition of technical success is defined as patency of the endovascular graft, with the absence of Type I or III endoleaks or aneurysm sac rupture, up to 30-days post-procedure completion as confirmed by CT or other imaging modality.
measure: Length of Hospital Stay (Days) Post Index Procedure
time frame: up to 17 days
measure: Length of Intensive Care Unit (ICU) Stay (Hours) Post Index Procedure
time frame: up to 48 hours
measure: Length of the Index Procedure (Minutes)
time frame: 1 day
measure: Pain Post-Operatively
time frame: Baseline, 1 month, 6 months and 1 year post-procedure
description: Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
measure: Physical Functioning Post-operatively
time frame: Screening, 1 month, 6 months and 1 year post-procedure
description: Physical Functioning (PF) Outcome measured by the SF36v2 Health Status Survey where all items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
arm group label: InCraft® - AAA stent graft system
arm group type: Experimental
description: Intervention: Endovascular AAA repair using the InCraft device
intervention type: Device
intervention name: Endovascular AAA repair with InCraft®
arm group label: InCraft® - AAA stent graft system
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Michel S Makaroun, MD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: Takao Ohki, MD
role: Principal Investigator
affiliation: Jikei University School of Medicine
facility: 
facility: 
country: Japan
country: United States
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Number of participants at risk my vary depending on varying windows used for analysis, imaging availability, visits completed and will therefore not be consistent throughout report.
point of contact: 