<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/NCT03035643</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00066039_AME3</org_study_id>
    <nct_id>NCT03035643</nct_id>
  </id_info>
  <brief_title>DARTS I Feasibility Study</brief_title>
  <acronym>DARTS I</acronym>
  <official_title>Dissected Aorta Repair Through Stent Implantation (DARTS): A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ascyrus Medical LLC.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Artivion Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Artivion Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the feasibility and clinical benefits of the&#xD;
      AMDS to treat patients with acute DeBakey type I dissections and/or intramural hematomas&#xD;
      (IMH) involving the ascending aorta and aortic arch through open surgical repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AMDS is designed to complement the replacement of the ascending aorta with conventional&#xD;
      surgical technique utilizing a conventional polyester graft. AMDS is constructed of an&#xD;
      uncovered Nitinol wire braided stent attached proximally to a polytetrafluoroethylene (PTFE)&#xD;
      felt graft component. The PFTE felt graft component excludes the FL at the distal aortic&#xD;
      anastomosis and the wire stent re-expands the dissection flap within the arch and descending&#xD;
      aorta, which aims to treat malperfusion and promote positive remodeling of the aorta.&#xD;
&#xD;
      The DARTS I Feasibility study is a prospective, non-randomized, non-blinded, single-arm,&#xD;
      multi-institutional Canadian study evaluating the feasibility and safety of the AMDS graft. A&#xD;
      goal of 40 subjects will be enrolled at approximately 5 sites in Canada.&#xD;
&#xD;
      The enrollment period will span a minimum of 12 months from Institutional Review Board (IRB)&#xD;
      approval and site activation. Candidates for this study are adults who require repair of an&#xD;
      acute DeBakey type I aorta dissection and/or intramural hematoma (IMH). Patients will be&#xD;
      consented pre-operatively and enrolled patients will be followed for approximately 5 years&#xD;
      after their AMDS implantation date. Data will be collected at 10 time points: baseline&#xD;
      (pre-operatively), discharge, 1 month post-operatively, 3 months post-operatively, and 6&#xD;
      months post-operatively, 1 year post-operatively and thereafter, annually, for a total of 5&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 5, 2017</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of AMDS</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with device-related mortality</measure>
    <time_frame>Early (within 30 days)</time_frame>
    <description>The number of patients with mortality related to the treatment device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with device-related mortality</measure>
    <time_frame>Intermediate (3 months)</time_frame>
    <description>The number of patients with mortality related to the treatment device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with device-related mortality</measure>
    <time_frame>Late (6 months)</time_frame>
    <description>The number of patients with mortality related to the treatment device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with neurological complications (TIA, stroke)</measure>
    <time_frame>Early (within 30 days)</time_frame>
    <description>The number of patients with neurological complications related to the treatment device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with neurological complications (TIA, stroke)</measure>
    <time_frame>Intermediate (3 months)</time_frame>
    <description>The number of patients with neurological complications related to the treatment device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with neurological complications (TIA, stroke)</measure>
    <time_frame>Late (6 months)</time_frame>
    <description>The number of patients with neurological complications related to the treatment device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thrombosis of the false lumen within the confines of the device</measure>
    <time_frame>Annually, through study completion, an average of 5 years</time_frame>
    <description>Efficacy outcome: Number of participants with false lumen exclusion within the treatment area confined by the treatment device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess need for stent removal</measure>
    <time_frame>Annually, through study completion, an average of 5 years</time_frame>
    <description>Stent placement and retention. The number of patients requiring removal of the stent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful reattachment of the intimal flap within the arch</measure>
    <time_frame>Annually, through study completion, an average of 5 years</time_frame>
    <description>The number of patients that has successful reattachment of the intimal flap within the arch following the implantation of AMDS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device</measure>
    <time_frame>Annually, through study completion, an average of 5 years</time_frame>
    <description>The number of patients which has successful AMDS deployment and which also had radiographic evidence of false lumen exclusion within the confines of AMDS</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Aortic injury associated with the implantation of the device</measure>
    <time_frame>Annually, through study completion, an average of 5 years</time_frame>
    <description>The number of patients which has any aortic injury(ies) associated with the implantation of AMDS</description>
  </other_outcome>
  <other_outcome>
    <measure>Aortic arch branch vessel patency</measure>
    <time_frame>Annually, through study completion, an average of 5 years</time_frame>
    <description>An evaluation of the patency of aortic arch branch vessels for patients which have had AMDS implantation. Aortic arch branch vessel patency will be evaluated by CTA with a Core Imaging Lab.</description>
  </other_outcome>
  <other_outcome>
    <measure>AMDS related re-interventions after the dissection repair</measure>
    <time_frame>Annually, through study completion, an average of 5 years</time_frame>
    <description>The number of patients which have required re-interventions related to the AMDS implantation following the index procedure for aortic dissection repair.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Aortic Dissection</condition>
  <condition>Intramural Hematoma</condition>
  <arm_group>
    <arm_group_label>AMDS Implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AMDS</intervention_name>
    <description>The device will be implanted during an already planned surgical intervention for aortic dissection repair. The participant will be observed and data gathered during the surgery and routine standard of care follow up visits.</description>
    <arm_group_label>AMDS Implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subject must have one of the following diagnosed, based on CT angiography, within 0-14&#xD;
        days:&#xD;
&#xD;
          1. Acute DeBakey type I dissection or&#xD;
&#xD;
          2. Acute DeBakey type I intramural hematoma (IMH)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General Exclusion Criteria&#xD;
&#xD;
        Patients must be excluded from the study if any of the following conditions are true:&#xD;
&#xD;
          1. Less than 18 years of age or over 80 years of age&#xD;
&#xD;
          2. Life expectancy less than 2 years&#xD;
&#xD;
          3. Pregnant or breastfeeding or planning on becoming pregnant within 60 months&#xD;
&#xD;
          4. Unwilling to comply with the follow-up schedule&#xD;
&#xD;
          5. Refusal to give informed consent&#xD;
&#xD;
        Medical Exclusion Criteria&#xD;
&#xD;
        Patients must be excluded from the study if any of the following conditions are true:&#xD;
&#xD;
          1. Uncontrolled systemic infection&#xD;
&#xD;
          2. Uncontrollable anaphylaxis to iodinated contrast&#xD;
&#xD;
          3. Known allergy(ies) to Nitinol and/or PTFE&#xD;
&#xD;
          4. Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation&#xD;
             (CPR)&#xD;
&#xD;
          5. Inability to obtain CT angiograms for follow-up&#xD;
&#xD;
          6. Previously diagnosed with Marfan syndrome, Loeys- Dietz syndrome or Ehlers- Danlos&#xD;
             syndrome with confirmed laboratory genetic testing on a date prior to the diagnosis of&#xD;
             the dissection&#xD;
&#xD;
        Anatomical Exclusion Criteria&#xD;
&#xD;
          1. Any pathology of mycotic origin&#xD;
&#xD;
          2. Subacute or chronic dissection of the ascending aorta and aortic arch (&gt;14 days after&#xD;
             the index event)&#xD;
&#xD;
          3. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)&#xD;
&#xD;
          4. Extensive thrombus or calcifications in the aortic arch as defined by CT angiography&#xD;
&#xD;
          5. Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography&#xD;
&#xD;
          6. Descending thoracic aneurysm involving the proximal third (1/3) of the descending&#xD;
             aorta and measuring &gt; 45mm in diameter.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica Forcillo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier de I'Universite de Montreal</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maral Ouzounian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network - Toronto General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Chu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Science Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philippe Demers</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montreal Heart Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Moon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mazankowski Alberta Heart Institute, University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Center- University Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network - Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Institute</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>HIT 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de I'Universite de Montreal (CHUM)</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Moon MC. Midterm Outcomes of the Dissected Aorta Repair Through Stent Implantation Trial. Ann Thorac Surg. 2021 Feb;111(2):463-470. doi: 10.1016/j.athoracsur.2020.05.090. Epub 2020 Jul 13.</citation>
    <PMID>32673661</PMID>
  </reference>
  <reference>
    <citation>Bozso SJ, Nagendran J, MacArthur RGG, Chu MWA, Kiaii B, El-Hamamsy I, Cartier R, Shahriari A, Moon MC. Dissected Aorta Repair Through Stent Implantation trial: Canadian results. J Thorac Cardiovasc Surg. 2019 May;157(5):1763-1771. doi: 10.1016/j.jtcvs.2018.09.120. Epub 2018 Oct 26.</citation>
    <PMID>30501947</PMID>
  </reference>
  <reference>
    <citation>Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Shahriari A, Moon MC. Single-Stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft. Ann Thorac Surg. 2019 Dec;108(6):1768-1775. doi: 10.1016/j.athoracsur.2019.04.121. Epub 2019 Jun 27.</citation>
    <PMID>31254509</PMID>
  </reference>
  <reference>
    <citation>Montagner M, Kofler M, Heck R, Buz S, Starck C, Kurz S, Falk V, Kempfert J. Initial experience with the new type A arch dissection stent: restoration of supra-aortic vessel perfusion. Interact Cardiovasc Thorac Surg. 2021 Jul 26;33(2):276-283. doi: 10.1093/icvts/ivab085.</citation>
    <PMID>34010408</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>February 25, 2022</last_update_submitted>
  <last_update_submitted_qc>February 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03035643
org study id: Pro00066039_AME3
nct id: NCT03035643
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to investigate the feasibility and clinical benefits of the
      AMDS to treat patients with acute DeBakey type I dissections and/or intramural hematomas
      (IMH) involving the ascending aorta and aortic arch through open surgical repair.
AMDS is designed to complement the replacement of the ascending aorta with conventional
      surgical technique utilizing a conventional polyester graft. AMDS is constructed of an
      uncovered Nitinol wire braided stent attached proximally to a polytetrafluoroethylene (PTFE)
      felt graft component. The PFTE felt graft component excludes the FL at the distal aortic
      anastomosis and the wire stent re-expands the dissection flap within the arch and descending
      aorta, which aims to treat malperfusion and promote positive remodeling of the aorta.

      The DARTS I Feasibility study is a prospective, non-randomized, non-blinded, single-arm,
      multi-institutional Canadian study evaluating the feasibility and safety of the AMDS graft. A
      goal of 40 subjects will be enrolled at approximately 5 sites in Canada.

      The enrollment period will span a minimum of 12 months from Institutional Review Board (IRB)
      approval and site activation. Candidates for this study are adults who require repair of an
      acute DeBakey type I aorta dissection and/or intramural hematoma (IMH). Patients will be
      consented pre-operatively and enrolled patients will be followed for approximately 5 years
      after their AMDS implantation date. Data will be collected at 10 time points: baseline
      (pre-operatively), discharge, 1 month post-operatively, 3 months post-operatively, and 6
      months post-operatively, 1 year post-operatively and thereafter, annually, for a total of 5
      years.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, non-randomized, non-blinded, single-arm study evaluating the feasibility and safety of AMDS
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with device-related mortality
time frame: Early (within 30 days)
description: The number of patients with mortality related to the treatment device
measure: Number of participants with device-related mortality
time frame: Intermediate (3 months)
description: The number of patients with mortality related to the treatment device
measure: Number of participants with device-related mortality
time frame: Late (6 months)
description: The number of patients with mortality related to the treatment device
measure: Number of participants with neurological complications (TIA, stroke)
time frame: Early (within 30 days)
description: The number of patients with neurological complications related to the treatment device
measure: Number of participants with neurological complications (TIA, stroke)
time frame: Intermediate (3 months)
description: The number of patients with neurological complications related to the treatment device
measure: Number of participants with neurological complications (TIA, stroke)
time frame: Late (6 months)
description: The number of patients with neurological complications related to the treatment device
measure: Thrombosis of the false lumen within the confines of the device
time frame: Annually, through study completion, an average of 5 years
description: Efficacy outcome: Number of participants with false lumen exclusion within the treatment area confined by the treatment device.
measure: Assess need for stent removal
time frame: Annually, through study completion, an average of 5 years
description: Stent placement and retention. The number of patients requiring removal of the stent.
measure: Successful reattachment of the intimal flap within the arch
time frame: Annually, through study completion, an average of 5 years
description: The number of patients that has successful reattachment of the intimal flap within the arch following the implantation of AMDS
measure: Successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device
time frame: Annually, through study completion, an average of 5 years
description: The number of patients which has successful AMDS deployment and which also had radiographic evidence of false lumen exclusion within the confines of AMDS
measure: Aortic injury associated with the implantation of the device
time frame: Annually, through study completion, an average of 5 years
description: The number of patients which has any aortic injury(ies) associated with the implantation of AMDS
measure: Aortic arch branch vessel patency
time frame: Annually, through study completion, an average of 5 years
description: An evaluation of the patency of aortic arch branch vessels for patients which have had AMDS implantation. Aortic arch branch vessel patency will be evaluated by CTA with a Core Imaging Lab.
measure: AMDS related re-interventions after the dissection repair
time frame: Annually, through study completion, an average of 5 years
description: The number of patients which have required re-interventions related to the AMDS implantation following the index procedure for aortic dissection repair.
arm group label: AMDS Implantation
arm group type: Experimental
description: AMDS implantation is performed during an open chest procedure for intervention of aortic dissection repair.
intervention type: Device
intervention name: AMDS
description: The device will be implanted during an already planned surgical intervention for aortic dissection repair. The participant will be observed and data gathered during the surgery and routine standard of care follow up visits.
arm group label: AMDS Implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jessica Forcillo, MD
role: Principal Investigator
affiliation: Centre Hospitalier de I'Universite de Montreal
last name: Maral Ouzounian, MD
role: Principal Investigator
affiliation: University Health Network - Toronto General Hospital
last name: Michael Chu, MD
role: Principal Investigator
affiliation: London Health Science Center
last name: Philippe Demers
role: Principal Investigator
affiliation: Montreal Heart Institute
last name: Michael Moon, MD
role: Principal Investigator
affiliation: University of Alberta
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
citation: Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Moon MC. Midterm Outcomes of the Dissected Aorta Repair Through Stent Implantation Trial. Ann Thorac Surg. 2021 Feb;111(2):463-470. doi: 10.1016/j.athoracsur.2020.05.090. Epub 2020 Jul 13.
PMID: 32673661
citation: Bozso SJ, Nagendran J, MacArthur RGG, Chu MWA, Kiaii B, El-Hamamsy I, Cartier R, Shahriari A, Moon MC. Dissected Aorta Repair Through Stent Implantation trial: Canadian results. J Thorac Cardiovasc Surg. 2019 May;157(5):1763-1771. doi: 10.1016/j.jtcvs.2018.09.120. Epub 2018 Oct 26.
PMID: 30501947
citation: Bozso SJ, Nagendran J, Chu MWA, Kiaii B, El-Hamamsy I, Ouzounian M, Kempfert J, Starck C, Shahriari A, Moon MC. Single-Stage Management of Dynamic Malperfusion Using a Novel Arch Remodeling Hybrid Graft. Ann Thorac Surg. 2019 Dec;108(6):1768-1775. doi: 10.1016/j.athoracsur.2019.04.121. Epub 2019 Jun 27.
PMID: 31254509
citation: Montagner M, Kofler M, Heck R, Buz S, Starck C, Kurz S, Falk V, Kempfert J. Initial experience with the new type A arch dissection stent: restoration of supra-aortic vessel perfusion. Interact Cardiovasc Thorac Surg. 2021 Jul 26;33(2):276-283. doi: 10.1093/icvts/ivab085.
PMID: 34010408
responsible party type: Sponsor
mesh term: Aortic Dissection
mesh term: Hematoma
sharing ipd: No