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/NCT06001918</url>
    </required_header>
    <id_info>
      <org_study_id>EAST002</org_study_id>
      <nct_id>NCT06001918</nct_id>
    </id_info>
    <brief_title>Nectero EAST System Clinical Study</brief_title>
    <acronym>stAAAble</acronym>
    <official_title>Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nectero Medical, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nectero Medical, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this randomized clinical trial is to treat patients with small to mid-sized&#xD;
        abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally&#xD;
        delivered, single-dose endovascular treatment. The main question the study aims to answer is&#xD;
        to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The&#xD;
        study will compare the treatment group to the typical standard of care for these patients,&#xD;
        surveillance. All subjects will be followed at designated intervals at 6, 12, 18 and 24&#xD;
        months with continued follow-up annually for up to 5 years.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
    <phase>Phase 2/Phase 3</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>Prospective, randomized, controlled trial comparing the efficacy of the treatment arm to the control arm.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>For this trial, neither the patient nor investigator will be blinded to the study group assignment. However, members of the Sponsor, the CT core laboratory and the various committees reviewing subject data, such as the Clinical Events Committee (CEC), will be blinded to the randomization and assignment arm for an individual subject under review.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Endpoint</measure>
      <time_frame>24 months</time_frame>
      <description>The primary endpoint is the number of participants experiencing AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Growth</measure>
      <time_frame>24 months</time_frame>
      <description>The growth over time in aneurysm diameter based on CT core laboratory readings.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Abdominal Aortic Aneurysm</condition>
    <arm_group>
      <arm_group_label>Treatment Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants assigned to the treatment arm will undergo an endovascular procedure using the Nectero EAST System to deliver the Stabilizer Infusion Solution directly inside the aneurysm. This is a one-time local delivery of the product. Following treatment, surveillance of their AAA will be conducted using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.&#xD;
  Intervention: Drug: Stabilizer</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants assigned to the control arm will undergo surveillance of their AAA using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nectero EAST System</intervention_name>
      <description>Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.</description>
      <arm_group_label>Treatment Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males and females ≥21 years of age. Females must be of non-childbearing potential&#xD;
               (menopause or sterilization).&#xD;
  &#xD;
            2. Subject understands the purpose of the trial, agrees to voluntarily participate in the&#xD;
               trial, signs the informed consent and is willing to complete the follow-up according&#xD;
               to the requirements of the protocol.&#xD;
  &#xD;
            3. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm&#xD;
               (male) and 3.5 cm to 4.5 cm (female).&#xD;
  &#xD;
            4. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.&#xD;
  &#xD;
            5. Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm)&#xD;
               not to exceed 130 mm.&#xD;
  &#xD;
            6. Iliac and femoral artery access, vessel size and morphology allow endovascular access&#xD;
               of 14F (or larger) introducer sheaths and catheters, including severe infrarenal neck&#xD;
               angulation.&#xD;
  &#xD;
            7. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria,&#xD;
               inclusive.&#xD;
  &#xD;
            8. Subject has &gt; two-year life expectancy.&#xD;
  &#xD;
            9. Subject is able and willing to comply with all required follow-up clinic visits&#xD;
               including CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5&#xD;
               years).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.&#xD;
  &#xD;
            2. Subject has a symptomatic infrarenal abdominal aortic aneurysm.&#xD;
  &#xD;
            3. Subject has a mycotic or infected aneurysm.&#xD;
  &#xD;
            4. Subject has current vascular injury due to trauma.&#xD;
  &#xD;
            5. Subject's aneurysm is thoracic, suprarenal or juxtarenal.&#xD;
  &#xD;
            6. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.&#xD;
  &#xD;
            7. Subject has anatomy of diffuse, ulcerated, or extensive (shaggy) thrombus in the neck&#xD;
               of the AAA, that in the opinion of the vascular surgeon/investigator, could result in&#xD;
               embolization of the thrombus.&#xD;
  &#xD;
            8. Subject has anatomy of calcification, and/or plaque within the ilio-femoral arteries&#xD;
               that may compromise or does not allow delivery of the Introducer Sheath or the&#xD;
               delivery catheter of the Nectero EAST System.&#xD;
  &#xD;
            9. Subject has had a myocardial infarction within six (6) months prior to enrollment or&#xD;
               elevated CK enzymes or troponin prior to procedure.&#xD;
  &#xD;
           10. Subject has current angina, unstable angina, or other active cardiac condition such as&#xD;
               congestive heart failure III and IV, untreated or worsening atrial arrhythmia,&#xD;
               ventricular arrhythmia, or valvular disease.&#xD;
  &#xD;
           11. Subject has undergone other major surgery within the 30 days prior to enrollment.&#xD;
  &#xD;
           12. Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months.&#xD;
  &#xD;
           13. Known allergy to contrast material, delivery system materials (i.e., nylon,&#xD;
               polyurethane) and/or Pentagalloyl Glucose (PGG).&#xD;
  &#xD;
           14. Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray&#xD;
               visualization of the aorta.&#xD;
  &#xD;
           15. Subject has connective tissue/collagen disorder (e.g., Marfan syndrome, vascular&#xD;
               Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease,&#xD;
               etc.).&#xD;
  &#xD;
           16. Known contraindication to undergoing angiography or receiving systemic&#xD;
               anticoagulation.&#xD;
  &#xD;
           17. Subject has active systemic infection.&#xD;
  &#xD;
           18. Subject is participating in another research trial that could interfere with the&#xD;
               results of the trial (e.g., drug trial).&#xD;
  &#xD;
           19. Subject has other medical, social, or psychological problems that, in the opinion of&#xD;
               the investigator, preclude them from participation in the trial and to undergo the&#xD;
               procedures and evaluations pre- and post-treatment.&#xD;
  &#xD;
           20. Subject has dialysis dependent renal failure or baseline serum creatinine level&#xD;
               &gt;2.5mg/dL or eGFR &lt; 45 mL/min/1.73m2.&#xD;
  &#xD;
           21. Subjects with liver dysfunction: alanine transaminase (ALT) or aspartate transaminase&#xD;
               (AST) which is 3 times higher than the normal upper limit; serum total bilirubin (STB)&#xD;
               that is 1.5 times higher than the normal upper limit or has clinical evidence of&#xD;
               jaundice.&#xD;
  &#xD;
           22. Subjects that may not tolerate the lowering of their systolic blood pressure to&#xD;
               approximately 100mmHg, should not be considered for this study or treated using the&#xD;
               Nectero EAST System.&#xD;
  &#xD;
           23. Subjects that may not be able to tolerate transient occlusion of the aorta should not&#xD;
               be considered for this study.&#xD;
  &#xD;
           24. Subjects with saccular AAA.&#xD;
  &#xD;
           25. Subjects with rapidly expanding AAA (previous diameter increases of ≥0.5 cm in&#xD;
               6-months or ≥1 cm in 1 year) as these should be evaluated for immediate repair.&#xD;
  &#xD;
           26. Subjects who are not suitable for the Nectero EAST System treatment, as determined by&#xD;
               the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel Clair, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Vanderbilt University Medical Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Grace Wang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pennsylvania</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Charlene Knape</last_name>
      <phone>866-755-4744</phone>
      <email>cknape@necteromedical.com</email>
    </overall_contact>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/37330148/</url>
      <description>J Vasc Surg. Pilot Study</description>
    </link>
    <reference>
      <citation>Cheng SWK, Eagleton M, Echeverri S, Munoz JG, Holden AH, Hill AA, Krievins D, Ramaiah V. A pilot study to evaluate a novel localized treatment to stabilize small- to medium-sized infrarenal abdominal aortic aneurysms. J Vasc Surg. 2023 Jun 15:S0741-5214(23)01313-7. doi: 10.1016/j.jvs.2023.05.056. Online ahead of print.</citation>
      <PMID>37330148</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>
    <!-- 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/NCT06001918
  org study id: EAST002
  nct id: NCT06001918
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this randomized clinical trial is to treat patients with small to mid-sized
        abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally
        delivered, single-dose endovascular treatment. The main question the study aims to answer is
        to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The
        study will compare the treatment group to the typical standard of care for these patients,
        surveillance. All subjects will be followed at designated intervals at 6, 12, 18 and 24
        months with continued follow-up annually for up to 5 years.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, randomized, controlled trial comparing the efficacy of the treatment arm to the control arm.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: For this trial, neither the patient nor investigator will be blinded to the study group assignment. However, members of the Sponsor, the CT core laboratory and the various committees reviewing subject data, such as the Clinical Events Committee (CEC), will be blinded to the randomization and assignment arm for an individual subject under review.
  measure: Primary Endpoint
  time frame: 24 months
  description: The primary endpoint is the number of participants experiencing AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm).
  measure: Growth
  time frame: 24 months
  description: The growth over time in aneurysm diameter based on CT core laboratory readings.
  arm group label: Treatment Arm
  arm group type: Experimental
  description: Participants assigned to the treatment arm will undergo an endovascular procedure using the Nectero EAST System to deliver the Stabilizer Infusion Solution directly inside the aneurysm. This is a one-time local delivery of the product. Following treatment, surveillance of their AAA will be conducted using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.
  Intervention: Drug: Stabilizer
  arm group label: Control Arm
  arm group type: No Intervention
  description: Participants assigned to the control arm will undergo surveillance of their AAA using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.
  intervention type: Drug
  intervention name: Nectero EAST System
  description: Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.
  arm group label: Treatment Arm
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Daniel Clair, MD
  role: Principal Investigator
  affiliation: Vanderbilt University Medical Center
  last name: Grace Wang, MD
  role: Principal Investigator
  affiliation: University of Pennsylvania
  last name: Charlene Knape
  phone: 866-755-4744
  email: cknape@necteromedical.com
  url: https://pubmed.ncbi.nlm.nih.gov/37330148/
  description: J Vasc Surg. Pilot Study
  citation: Cheng SWK, Eagleton M, Echeverri S, Munoz JG, Holden AH, Hill AA, Krievins D, Ramaiah V. A pilot study to evaluate a novel localized treatment to stabilize small- to medium-sized infrarenal abdominal aortic aneurysms. J Vasc Surg. 2023 Jun 15:S0741-5214(23)01313-7. doi: 10.1016/j.jvs.2023.05.056. Online ahead of print.
  PMID: 37330148
  responsible party type: Sponsor
  mesh term: Aneurysm
  mesh term: Aortic Aneurysm
  mesh term: Aortic Aneurysm, Abdominal