xml: <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/NCT06029660</url>
    </required_header>
    <id_info>
      <org_study_id>CRD 1029</org_study_id>
      <nct_id>NCT06029660</nct_id>
    </id_info>
    <brief_title>AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion</brief_title>
    <official_title>AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shape Memory Medical, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>NAMSA</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shape Memory Medical, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage&#xD;
        of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to&#xD;
        on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects&#xD;
        considered candidates for elective EVAR.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">June 2030</completion_date>
    <primary_completion_date type="Anticipated">June 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A prospective, multicenter, randomized, open-label trial.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Subjects will be blinded to the treatment arm prior to the index procedure; after the procedure, they will be unblinded prior to discharge to prevent unintentional unblinding due to imaging</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Effectiveness Endpoint</measure>
      <time_frame>1 year</time_frame>
      <description>The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year, and no AAA-related intervention through 1 year.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Primary Safety Endpoint</measure>
      <time_frame>30 days</time_frame>
      <description>Freedom from the following through 30 days post-index procedure:&#xD;
  Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss &gt;1000 mL.&#xD;
  AAA-rupture or AAA-perforation&#xD;
  Conversion to Open Repair</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Aortic Aneurysm, Abdominal</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Control Arm: Subjects in the control arm will only have an EVAR device implanted.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>IMPEDE-FX RapidFill Implants</intervention_name>
      <description>Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>EndoVascular Aneurysm Repair</intervention_name>
      <description>Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Treatment</arm_group_label>
      <other_name>EVAR</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ≥18 years of age&#xD;
  &#xD;
            2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in&#xD;
               diameter in men and ≥5.0 cm in women;&#xD;
  &#xD;
            3. Thrombus burden (percentage of the AAA sac occupied by thrombus) &lt;50%, based on&#xD;
               pre-procedure CTA&#xD;
  &#xD;
            4. Maximum Lumen diameter within the AAA sac of ≥40mm.&#xD;
  &#xD;
            5. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          General&#xD;
  &#xD;
            1. An inability to provide informed consent.&#xD;
  &#xD;
            2. Enrolled in another clinical study that could interfere with the outcomes being&#xD;
               studied in this trial.&#xD;
  &#xD;
            3. Unable or unwilling to comply with study follow-up requirements.&#xD;
  &#xD;
            4. Prisoner or member of other vulnerable population&#xD;
  &#xD;
          Anatomical&#xD;
  &#xD;
            1. Concomitant iliac artery ectasia or aneurysm&#xD;
  &#xD;
            2. Vascular disease and/or anatomy that preclude the safe access and positioning of a&#xD;
               catheter to deliver the investigational product into the AAA sac.&#xD;
  &#xD;
            3. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.&#xD;
  &#xD;
            4. Connective tissue disorder (e.g., Marfan's syndrome)&#xD;
  &#xD;
            5. Aneurysmal disease of the descending thoracic aorta&#xD;
  &#xD;
            6. Excessive calcification at the aortic bifurcation to common/internal iliac&#xD;
               bifurcation, that might lead to access difficulties&#xD;
  &#xD;
          EVAR/Procedural&#xD;
  &#xD;
            1. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore&#xD;
               Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft,&#xD;
               Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to&#xD;
               treat the AAA&#xD;
  &#xD;
            2. Use of an aortic stent graft other than those specified1 for a particular site&#xD;
  &#xD;
            3. Planned use of the chosen stent graft outside its instructions for use (IFU)&#xD;
  &#xD;
            4. Use of fenestrated stent grafts or chimney techniques&#xD;
  &#xD;
            5. Use of the Heli-FX EndoAnchor system&#xD;
  &#xD;
            6. Use of embolic devices other than the investigational product to embolize the AAA sac&#xD;
  &#xD;
            7. Use of embolic products to prophylactically or concomitantly embolize the inferior&#xD;
               mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac&#xD;
               arteries&#xD;
  &#xD;
            8. Inability to land the distal-most portion of the EVAR stent graft limbs, including&#xD;
               extensions, above the internal iliac arteries&#xD;
  &#xD;
          Medical History/Conditions&#xD;
  &#xD;
            1. Coagulopathy or uncontrolled bleeding disorder&#xD;
  &#xD;
            2. Serum creatinine level &gt;2.5 mg/dL&#xD;
  &#xD;
            3. Cerebrovascular accident within 3 months prior to the procedure&#xD;
  &#xD;
            4. Myocardial infarction and/or major heart surgery within 3 months prior to the&#xD;
               procedure&#xD;
  &#xD;
            5. Atrial fibrillation that is not well rate controlled&#xD;
  &#xD;
            6. Life expectancy of &lt;2 years post-procedure&#xD;
  &#xD;
            7. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.&#xD;
  &#xD;
            8. Have active infection at the time of the index procedure documented by pain, fever,&#xD;
               drainage, positive culture, or leukocytosis (WBC &gt;11,000/mm3)&#xD;
  &#xD;
            9. A condition that inhibits radiographic visualization during the implantation procedure&#xD;
  &#xD;
           10. History of allergy to contrast medium that cannot be managed medically, or subject is&#xD;
               unable to have a CT with contrast for any reason.&#xD;
  &#xD;
           11. Uncontrolled co-morbid medical condition, including mental health issues, that would&#xD;
               adversely affect participation in the trial&#xD;
  &#xD;
           12. Pregnant or lactating female: for females of child-bearing potential, based on a&#xD;
               positive pregnancy test within 7 days prior to the procedure or refusal to use a&#xD;
               medically accepted method of birth control for the duration of the trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Irene Kuhn</last_name>
      <phone>646-369-1591</phone>
      <email>ikuhn@namsa.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Peter Miller</last_name>
      <email>p.miller@shapemem.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029660
  org study id: CRD 1029
  nct id: NCT06029660
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage
        of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to
        on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects
        considered candidates for elective EVAR.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A prospective, multicenter, randomized, open-label trial.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Subjects will be blinded to the treatment arm prior to the index procedure; after the procedure, they will be unblinded prior to discharge to prevent unintentional unblinding due to imaging
  measure: Primary Effectiveness Endpoint
  time frame: 1 year
  description: The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year, and no AAA-related intervention through 1 year.
  measure: Primary Safety Endpoint
  time frame: 30 days
  description: Freedom from the following through 30 days post-index procedure:
  Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1000 mL.
  AAA-rupture or AAA-perforation
  Conversion to Open Repair
  arm group label: Treatment
  arm group type: Experimental
  description: Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted.
  arm group label: Control
  arm group type: Active Comparator
  description: Control Arm: Subjects in the control arm will only have an EVAR device implanted.
  intervention type: Device
  intervention name: IMPEDE-FX RapidFill Implants
  description: Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants
  arm group label: Treatment
  intervention type: Procedure
  intervention name: EndoVascular Aneurysm Repair
  description: Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.
  arm group label: Control
  arm group label: Treatment
  other name: EVAR
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Irene Kuhn
  phone: 646-369-1591
  email: ikuhn@namsa.com
  last name: Peter Miller
  email: p.miller@shapemem.com
  responsible party type: Sponsor
  mesh term: Aneurysm
  mesh term: Aortic Aneurysm
  mesh term: Aortic Aneurysm, Abdominal
  sharing ipd: No