<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/NCT03033043</url>
  </required_header>
  <id_info>
    <org_study_id>IP-0017-16</org_study_id>
    <nct_id>NCT03033043</nct_id>
  </id_info>
  <brief_title>Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection</brief_title>
  <official_title>A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bolton Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bolton Medical</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>
      This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed&#xD;
      to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B&#xD;
      aortic dissection. The primary endpoint will measure all-cause mortality at 30 days&#xD;
      post-procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed&#xD;
      to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B&#xD;
      aortic dissection. The primary endpoint will measure all-cause mortality at 30 days&#xD;
      post-procedure.&#xD;
&#xD;
      Subjects will be enrolled on a first come, first serve basis; however, no single&#xD;
      investigational site may enroll more than 20% of the proposed sample size of up to 80&#xD;
      subjects. A subject is considered enrolled when arterial access is gained and an attempt is&#xD;
      made to introduce the RelayPro Thoracic Stent-Graft. Enrollment is expected to begin in&#xD;
      mid-2016 and complete by the end of 2020.&#xD;
&#xD;
      All subjects enrolled, as defined above, will be included in the patient population for the&#xD;
      primary safety analyses. All subjects implanted with the RelayPro Thoracic Stent-Graft will&#xD;
      be included in the patient population for the primary effectiveness analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 14, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">March 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality post-procedure</measure>
    <time_frame>30 days</time_frame>
    <description>All-cause mortality 30 days post-procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical Success at the time of the index procedure</measure>
    <time_frame>During deployment of the device</time_frame>
    <description>Successful delivery and deployment of the device, including withdrawal of the delivery system;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment success through 1 month</measure>
    <time_frame>1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite</time_frame>
    <description>Absence of Major adverse Event (MAE)&#xD;
Absence of relevant MAEs:&#xD;
Paraplegia;&#xD;
Paraparesis;&#xD;
New ischemia due to branch vessel compromise;&#xD;
Absence of unintentional rupture of the dissection septum;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dissection Treatment Success</measure>
    <time_frame>1, 6, and 12 month follow-up visits, and annually through 5 years.</time_frame>
    <description>• Dissection treatment success through 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Aortic Dissection Type B</condition>
  <arm_group>
    <arm_group_label>Experimental: Relay Pro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Relay Pro Stent-Graft</intervention_name>
    <description>Endovascular treatment of an aortic dissection</description>
    <arm_group_label>Experimental: Relay Pro</arm_group_label>
    <other_name>Relay Pro Stent Graft System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must have an acute (symptom onset to diagnosis within 2 weeks)or subacute,&#xD;
             complicated type B aortic dissection (entire dissection is distal to the left&#xD;
             subclavian artery (LSA)), confirmed by Computed Tomography Angiography (CTA) or&#xD;
             Magnetic Resonance Angiogram (MRA), with time from symptom onset to diagnosis ≤ 6&#xD;
             weeks, with at least one of the following:&#xD;
&#xD;
               -  Malperfusion of the viscera, kidneys, spinal cord, or lower extremities, measured&#xD;
                  by clinical or radiographic evidence;&#xD;
&#xD;
               -  Rupture;&#xD;
&#xD;
               -  Intractable pain.&#xD;
&#xD;
          -  Proximal and distal aortic neck with diameter between 19 mm and 42 mm.&#xD;
&#xD;
          -  Subject's anatomy must meet all of the following anatomical criteria:&#xD;
&#xD;
               1. Proximal attachment zone distal to the left common carotid and a distal&#xD;
                  attachment zone proximal to the origin of the celiac artery. (Dissection is&#xD;
                  permitted in the distal attachment zone but is not permitted in the proximal&#xD;
                  attachment zone.)&#xD;
&#xD;
               2. The length of the attachment zones will depend on the intended stent-graft&#xD;
                  diameter and type of graft selected.&#xD;
&#xD;
               3. The proximal attachment zone should be 15 mm for 22 - 28 mm RelayPro grafts with&#xD;
                  bare stent (20 mm for RelayPro grafts with non-bare stent), 20 mm for 30 - 46 mm&#xD;
                  RelayPro grafts with bare stent (25 mm for RelayPro grafts with non-bare stent),&#xD;
                  and proximal to non-dissected segment (healthy zone).&#xD;
&#xD;
               4. The distal attachment zone should be 20 mm for all RelayPro grafts.&#xD;
&#xD;
               5. Coverage of the left subclavian artery is permitted with mandatory&#xD;
                  revascularization if patent left internal mammary artery (LIMA) bypass or left&#xD;
                  upper extremity (LUE) arteriovenous graft or anomalous vertebral artery off the&#xD;
                  aorta. Revascularization must be performed prior to device placement, and may&#xD;
                  occur during implant procedure, provided it is before coverage of the LSA by the&#xD;
                  endograft.&#xD;
&#xD;
          -  Proximal attachment zone containing a straight segment (non-tapered,&#xD;
             non-reverse-tapered, defined by &lt;10% diameter change) with lengths equal to or greater&#xD;
             than the required attachment length for the intended device.&#xD;
&#xD;
          -  Vascular dimensions (e.g., aortic diameters, length from left subclavian to celiac&#xD;
             artery) must be in the range that can be safely treated with the RelayPro Thoracic&#xD;
             Stent-Grafts.&#xD;
&#xD;
          -  Adequate iliac or femoral artery access for introduction of the RelayPro Delivery&#xD;
             System. Alternative methods to gain proper access may be utilized (e.g., iliac&#xD;
             conduit).&#xD;
&#xD;
          -  Subject willing to comply with the follow-up evaluation schedule.&#xD;
&#xD;
          -  Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent&#xD;
             Form prior to treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of traumatic injury or transection of the descending thoracic aorta.&#xD;
&#xD;
          -  Significant stenosis, calcification, thrombus, or tortuosity of intended fixation&#xD;
             sites that would compromise fixation or seal of the device.&#xD;
&#xD;
          -  Planned coverage of left carotid or celiac arteries; or anatomic variants that would&#xD;
             compromise circulation to the carotid, vertebral, or innominate arteries after device&#xD;
             placement, which is not amenable to subclavian revascularization.&#xD;
&#xD;
          -  Prior endovascular or surgical repair in the descending thoracic aorta. The device may&#xD;
             not be placed within any prior endovascular or surgical graft.&#xD;
&#xD;
          -  Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta,&#xD;
             requiring repair. Dissection extension into the abdominal aorta is acceptable.&#xD;
&#xD;
          -  Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed&#xD;
             less than 6 months prior to the planned stent implant procedure.&#xD;
&#xD;
          -  Major surgical or medical procedure within 30 days prior to the planned procedure, or&#xD;
             is scheduled for a major surgical or medical procedure within 30 days post&#xD;
             implantation. This excludes any planned procedures for the prospective stent-graft&#xD;
             placement.&#xD;
&#xD;
          -  Untreatable allergy or sensitivity to contrast media or device components, including&#xD;
             metal stents.&#xD;
&#xD;
          -  Known or suspected connective tissue disorder.&#xD;
&#xD;
          -  Blood coagulation disorder or bleeding diathesis for which the treatment cannot be&#xD;
             suspended for one week pre- and/or post-repair.&#xD;
&#xD;
          -  Coronary artery disease with unstable angina.&#xD;
&#xD;
          -  Severe congestive heart failure (New York Heart Association functional class IV).&#xD;
&#xD;
          -  Stroke and/or Myocardial Infarction (MI) within 3 months of the planned treatment&#xD;
             date.&#xD;
&#xD;
          -  Pulmonary disease requiring the routine (daily or nightly) need for oxygen therapy&#xD;
             outside the hospital setting.&#xD;
&#xD;
          -  Acute renal failure or chronic renal insufficiency, and not receiving dialysis.&#xD;
&#xD;
          -  Hemodynamically unstable.&#xD;
&#xD;
          -  Active systemic infection and/or mycotic aneurysms.&#xD;
&#xD;
          -  Bowel necrosis.&#xD;
&#xD;
          -  Morbid obesity or other condition that may compromise or prevent the necessary imaging&#xD;
             requirements.&#xD;
&#xD;
          -  ASA risk classification = V (Moribund patient not expected to live 24 hours with or&#xD;
             without operation).&#xD;
&#xD;
          -  Less than two-year life expectancy.&#xD;
&#xD;
          -  Current or planned participation in an investigational drug or device study that has&#xD;
             not completed primary endpoint evaluation.&#xD;
&#xD;
          -  Currently pregnant or planning to become pregnant during the course of the study.&#xD;
&#xD;
          -  Medical, social, or psychological issues that Investigator believes may interfere with&#xD;
             treatment or follow-up.&#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_official>
    <last_name>Christian Shults, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medstar Washington Hospital Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Rossi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of WI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Long Beach Memorial Hospital</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC Department of Surgery</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California at Los Angeles (UCLA)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medstar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Heart Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospital and Clinic</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center (UMB)</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Health System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newark Beth Israel Med Ctr / Saint Barnabas Med Ctr</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buffalo General Medical Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atrium Health (Sanger Heart &amp; Vascular)</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Heart Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Medical Center / Penn Presbyterian</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Medical Center</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Central Heart</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CVA Heart Institute</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37664</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Cardiothoracic and Vascular Surgeons</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Houston- Memorial Hermann Texas Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Heart Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carilion Roanoke Memorial Hospital</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of WI, Vascular Surgery</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 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>aortic</keyword>
  <keyword>dissection</keyword>
  <keyword>type B</keyword>
  <keyword>thoracic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</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/NCT03033043
org study id: IP-0017-16
nct id: NCT03033043
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed
      to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B
      aortic dissection. The primary endpoint will measure all-cause mortality at 30 days
      post-procedure.
This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed
      to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B
      aortic dissection. The primary endpoint will measure all-cause mortality at 30 days
      post-procedure.

      Subjects will be enrolled on a first come, first serve basis; however, no single
      investigational site may enroll more than 20% of the proposed sample size of up to 80
      subjects. A subject is considered enrolled when arterial access is gained and an attempt is
      made to introduce the RelayPro Thoracic Stent-Graft. Enrollment is expected to begin in
      mid-2016 and complete by the end of 2020.

      All subjects enrolled, as defined above, will be included in the patient population for the
      primary safety analyses. All subjects implanted with the RelayPro Thoracic Stent-Graft will
      be included in the patient population for the primary effectiveness analyses.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause mortality post-procedure
time frame: 30 days
description: All-cause mortality 30 days post-procedure
measure: Technical Success at the time of the index procedure
time frame: During deployment of the device
description: Successful delivery and deployment of the device, including withdrawal of the delivery system;
measure: Treatment success through 1 month
time frame: 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite
description: Absence of Major adverse Event (MAE)
Absence of relevant MAEs:
Paraplegia;
Paraparesis;
New ischemia due to branch vessel compromise;
Absence of unintentional rupture of the dissection septum;
measure: Dissection Treatment Success
time frame: 1, 6, and 12 month follow-up visits, and annually through 5 years.
description: • Dissection treatment success through 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite
arm group label: Experimental: Relay Pro
arm group type: Experimental
description: The Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections.
intervention type: Device
intervention name: Relay Pro Stent-Graft
description: Endovascular treatment of an aortic dissection
arm group label: Experimental: Relay Pro
other name: Relay Pro Stent Graft System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Shults, MD
role: Principal Investigator
affiliation: Medstar Washington Hospital Center
last name: Peter Rossi, MD
role: Principal Investigator
affiliation: Medical College of WI
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country: United States
responsible party type: Sponsor
mesh term: Aortic Dissection
sharing ipd: No