<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/NCT03005418</url>
  </required_header>
  <id_info>
    <org_study_id>CLN-PRO-V005</org_study_id>
    <nct_id>NCT03005418</nct_id>
  </id_info>
  <brief_title>Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma</brief_title>
  <official_title>A Phase 2 Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients With Life or Limb-threatening Vascular Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Humacyte, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Atlantic Research Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>U.S. Army Medical Research and Development Command</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Humacyte, 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>
      This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular&#xD;
      trauma below the neck who are undergoing vascular reconstructive surgery. There will be a&#xD;
      torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition&#xD;
      vessel or bypass using standard vascular surgical techniques. There is no control arm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, multi cohort, non-randomized phase 2 study in up to 40&#xD;
      adult patients with life or limb threatening vascular trauma which requires surgical repair.&#xD;
      There will be a limb cohort and a torso cohort. The limb cohort will include patients who&#xD;
      require repair of a vessel contained to the upper or lower extremity. The torso cohort&#xD;
      includes patients who require repair of vessels within the thorax (excluding the heart),&#xD;
      abdomen, and retroperitoneum. Subjects will be implanted with a Humacyte Human Acellular&#xD;
      Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical&#xD;
      techniques. There is no control arm.&#xD;
&#xD;
      The active study duration for each study participant will be 36 months from HAV implantation&#xD;
      or until HAV failure/ removal/ death if earlier. Follow up after month 12 will involve the&#xD;
      capture of information on assessments performed at &quot;standard of care&quot; routine clinic visits&#xD;
      or by telephone follow up with the patient or his/her physician with physical exam and&#xD;
      ultrasound at month 24 and month 36&#xD;
&#xD;
      The total expected duration of the clinical study is 61 months (24 months of enrollment and&#xD;
      36 months of follow up).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">February 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HAV primary patency</measure>
    <time_frame>30 days</time_frame>
    <description>Primary patency is defined as 'the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency', i.e., patent without interventions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency and Severity of Adverse Events</measure>
    <time_frame>36 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Limb viability (avoidance of amputation; limb cohort only)</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAV primary patency</measure>
    <time_frame>36 months</time_frame>
    <description>Primary patency is defined as 'the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency', i.e., patent without interventions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAV primary assisted patency</measure>
    <time_frame>36 months</time_frame>
    <description>Primary assisted patency is defined as 'the interval from the time of access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of patent access' i.e., patent without an intervention to clear a thrombus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAV secondary patency</measure>
    <time_frame>36 months</time_frame>
    <description>Secondary patency is defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of HAV interventions</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient survival</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAV remodeling as shown by histopathology of any clinical explants</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of anastomotic bleeding or spontaneous rupture</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of HAV infection</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of HAV thrombosis</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of HAV pseudoaneursym formation</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of HAV aneursym formation</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of HAV of hemodynamically significant stenosis (&gt;70% by duplex ultrasound criteria)</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of HAV removal</measure>
    <time_frame>36 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Trauma</condition>
  <condition>Vascular System Injury</condition>
  <arm_group>
    <arm_group_label>Human Acellular Vessel (HAV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, will be implanted with the Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Human Acellular Vessel (HAV)</intervention_name>
    <description>The investigational medicinal product (IMP) - the Human Acellular Vessel (HAV) is a sterile acellular tubular graft composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin which can be used for arterial bypass or reconstruction in patients with life or limb threatening vascular trauma. The vessel is 6 mm in diameter and approximately 42 cm in length. The product is supplied on a silicone mandrel immersed in sterile phosphate buffered saline in a sealed and labeled plastic container. The Humacyte HAV is implanted using standard vascular surgical techniques similar to placement of predicate peripheral vascular prostheses.</description>
    <arm_group_label>Human Acellular Vessel (HAV)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with life or limb threatening traumatic injury to an arterial vessel in the&#xD;
             limb or torso, other than the heart, which requires replacement or reconstruction&#xD;
&#xD;
          2. Preoperative imaging or clinical examination indicates the damaged vessel has a defect&#xD;
             length of ≤ 38cm and is appropriately size matched to the 6mm Human Acellular Vessel&#xD;
             (HAV) per the judgment of the treating surgeon taking into account vasoconstriction&#xD;
             and situational inflow and outflow considerations.&#xD;
&#xD;
          3. Autologous vein graft is either not feasible in the judgment of the treating surgeon&#xD;
             (e.g. because of lack of availability of suitable conduit, presence of severe venous&#xD;
             insufficiency) or is not desirable because of the urgency of revascularization&#xD;
&#xD;
          4. Aged 18 to 85 years old, inclusive&#xD;
&#xD;
          5. Able to communicate meaningfully with investigative staff, and able to comply with&#xD;
             entire study procedures. If the patient is unconscious, then information from a&#xD;
             reliable witness indicates that the patient would normally be able to comply with&#xD;
             study procedures&#xD;
&#xD;
          6. Patient or relative is able, willing and competent to give informed consent&#xD;
&#xD;
          7. Life expectancy of at least 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mangled Extremity Severity Score (MESS) of ≥ 7&#xD;
&#xD;
          2. Limb at high risk of amputation despite vascular reconstruction (e.g., because of&#xD;
             crush injury)&#xD;
&#xD;
          3. Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS)&#xD;
             &gt; 5 or Injury Severity Score (ISS) &gt;60)&#xD;
&#xD;
          4. HAV may not be used for coronary artery repair&#xD;
&#xD;
          5. Known pregnant women&#xD;
&#xD;
          6. Known medical condition which would preclude long term antiplatelet therapy after&#xD;
             resolution of acute injuries&#xD;
&#xD;
          7. Any other condition which in the judgment of the investigator would preclude adequate&#xD;
             evaluation of the safety and efficacy of the HAV&#xD;
&#xD;
          8. Previous exposure to HAV&#xD;
&#xD;
          9. Known participation in any investigational study within the last 30 days&#xD;
&#xD;
         10. Employees of the sponsor or patients who are employees or relatives of the&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shamik Parikh, MD</last_name>
    <role>Study Director</role>
    <affiliation>Humacyte, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elizabeth Taylor</last_name>
    <phone>919-313-9633</phone>
    <phone_ext>185</phone_ext>
    <email>etaylor@humacyte.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mark Tulchinskiy, MD</last_name>
    <phone>919-313-9633</phone>
    <email>mtulchinskiy@humacyte.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jacob Medical Center at UC San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Keck Hospital of University of Southern California (USC)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Cener</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCI Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University California, Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California San Diego (UCSD) Medical Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ernest E Moore Shock Trauma Center at Denver Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UF Health Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jackson South Medical Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ryder Trauma Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>R Adams Cowley Baltimore Shock Trauma</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saint Louis University (SLU)</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cooper University Hospital</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rutgers New Jersey Medical School</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Duke University Hospital</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Atrium Health Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wake Forest School of Medicine</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justin Hurie, MD</last_name>
      <email>jhurie@wakehealth.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Penn Presbyterian Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The University of Texas - Dell Medical School</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center - Vascular Surgery Department</name>
      <address>
        <city>Be'er Sheva</city>
        <zip>8410101</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus - Vascular Surgery Department</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center - Vascular Surgery Department</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</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>Vascular System Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03005418
org study id: CLN-PRO-V005
nct id: NCT03005418
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates the use of the Human Acellular Vessel (HAV) in adults with vascular
      trauma below the neck who are undergoing vascular reconstructive surgery. There will be a
      torso cohort and a limb cohort. All subjects will be implanted with a HAV as an interposition
      vessel or bypass using standard vascular surgical techniques. There is no control arm.
This is a prospective, multicenter, multi cohort, non-randomized phase 2 study in up to 40
      adult patients with life or limb threatening vascular trauma which requires surgical repair.
      There will be a limb cohort and a torso cohort. The limb cohort will include patients who
      require repair of a vessel contained to the upper or lower extremity. The torso cohort
      includes patients who require repair of vessels within the thorax (excluding the heart),
      abdomen, and retroperitoneum. Subjects will be implanted with a Humacyte Human Acellular
      Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical
      techniques. There is no control arm.

      The active study duration for each study participant will be 36 months from HAV implantation
      or until HAV failure/ removal/ death if earlier. Follow up after month 12 will involve the
      capture of information on assessments performed at "standard of care" routine clinic visits
      or by telephone follow up with the patient or his/her physician with physical exam and
      ultrasound at month 24 and month 36

      The total expected duration of the clinical study is 61 months (24 months of enrollment and
      36 months of follow up).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: HAV primary patency
time frame: 30 days
description: Primary patency is defined as 'the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency', i.e., patent without interventions
measure: Frequency and Severity of Adverse Events
time frame: 36 months
measure: Limb viability (avoidance of amputation; limb cohort only)
time frame: 36 months
measure: HAV primary patency
time frame: 36 months
description: Primary patency is defined as 'the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency', i.e., patent without interventions
measure: HAV primary assisted patency
time frame: 36 months
description: Primary assisted patency is defined as 'the interval from the time of access placement until access thrombosis or the time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of patent access' i.e., patent without an intervention to clear a thrombus
measure: HAV secondary patency
time frame: 36 months
description: Secondary patency is defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions
measure: Rate of HAV interventions
time frame: 36 months
measure: Patient survival
time frame: 36 months
measure: HAV remodeling as shown by histopathology of any clinical explants
time frame: 36 months
measure: Frequency of anastomotic bleeding or spontaneous rupture
time frame: 36 months
measure: Frequency of HAV infection
time frame: 36 months
measure: Frequency of HAV thrombosis
time frame: 36 months
measure: Frequency of HAV pseudoaneursym formation
time frame: 36 months
measure: Frequency of HAV aneursym formation
time frame: 36 months
measure: Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria)
time frame: 36 months
measure: Frequency of HAV removal
time frame: 36 months
arm group label: Human Acellular Vessel (HAV)
arm group type: Experimental
description: Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, will be implanted with the Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques.
intervention type: Biological
intervention name: Human Acellular Vessel (HAV)
description: The investigational medicinal product (IMP) - the Human Acellular Vessel (HAV) is a sterile acellular tubular graft composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin which can be used for arterial bypass or reconstruction in patients with life or limb threatening vascular trauma. The vessel is 6 mm in diameter and approximately 42 cm in length. The product is supplied on a silicone mandrel immersed in sterile phosphate buffered saline in a sealed and labeled plastic container. The Humacyte HAV is implanted using standard vascular surgical techniques similar to placement of predicate peripheral vascular prostheses.
arm group label: Human Acellular Vessel (HAV)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Shamik Parikh, MD
role: Study Director
affiliation: Humacyte, Inc.
last name: Elizabeth Taylor
phone: 919-313-9633
phone ext: 185
email: etaylor@humacyte.com
last name: Mark Tulchinskiy, MD
phone: 919-313-9633
email: mtulchinskiy@humacyte.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Israel
country: United States
responsible party type: Sponsor
mesh term: Vascular System Injuries
mesh term: Wounds and Injuries
sharing ipd: No