<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/NCT01676376</url>
  </required_header>
  <id_info>
    <org_study_id>11016</org_study_id>
    <nct_id>NCT01676376</nct_id>
  </id_info>
  <brief_title>The eMESH 1 Feasibility Study</brief_title>
  <acronym>eMESH 1</acronym>
  <official_title>A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kips Bay Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kips Bay Medical, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate&#xD;
      feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an&#xD;
      external vein support device for use over saphenous vein grafts during coronary artery bypass&#xD;
      surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh&#xD;
      (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study&#xD;
      subject will receive one SVG with the eSVS Mesh.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MACE</measure>
    <time_frame>30 days</time_frame>
    <description>The rate of major adverse coronary events (MACE) defined as the rate of the composite of total mortality, MI (Q wave and non Q wave), and/or coronary target vessel revascularization (percutaneous coronary intervention or CABG).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SVG patency determined by angiography</measure>
    <time_frame>6 months</time_frame>
    <description>Angiographic patency rate of the enrolled grafts defined as &lt; 50% stenosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Technical success implanting eSVS Mesh</measure>
    <time_frame>intra-operative</time_frame>
    <description>Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MACCE and mediastinitis</measure>
    <time_frame>5 years</time_frame>
    <description>MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SVG patency determined by angiography</measure>
    <time_frame>6 months</time_frame>
    <description>Angiographic patency rate of the enrolled grafts defined as &lt; 75%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque burden</measure>
    <time_frame>6 months</time_frame>
    <description>Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)</condition>
  <arm_group>
    <arm_group_label>eSVS Mesh treated saphenous vein graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control saphenous vein graft</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Vessel Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>eSVS Mesh treated saphenous vein graft</intervention_name>
    <description>During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.</description>
    <arm_group_label>Single Vessel Treatment</arm_group_label>
    <arm_group_label>eSVS Mesh treated saphenous vein graft</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control saphenous vein graft</intervention_name>
    <description>During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.</description>
    <arm_group_label>Control saphenous vein graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Randomized Cohort: Requires CABG surgery with a SVG to the right coronary artery (RCA)&#xD;
             system AND the left circumflex artery (LCX) system with a ≥ 70% stenosis in each of&#xD;
             the two systems.&#xD;
&#xD;
          -  Single Vessel Cohort: Requires CABG surgery with a SVG to the RCA system or the LCX&#xD;
             system with a &gt; 70% stenosis in the system.&#xD;
&#xD;
          -  Medial sternotomy with cardiopulmonary bypass (CPB) during surgery.&#xD;
&#xD;
          -  Both saphenous vein graft length are adequate for planned intervention, vein outer&#xD;
             diameter is between 3.6 mm and 7.0 mm and double wall thickness less than 1.4 mm.&#xD;
&#xD;
          -  Agreement to post-procedure follow-up contact and testing (including follow-up&#xD;
             coronary angiogram).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant non-CABG cardiac procedure.&#xD;
&#xD;
          -  Prior cardiac surgery (does not include percutaneous procedures).&#xD;
&#xD;
          -  Cerebrovascular or transient ischemia attack within 30 days of the CABG procedure.&#xD;
&#xD;
          -  Age &gt; 85 years.&#xD;
&#xD;
          -  Left ventricular ejection fraction ≤ 35%.&#xD;
&#xD;
          -  Creatinine &gt; 133 μmol/L (1.5 mg/dL) prior to CABG procedure or on chronic dialysis.&#xD;
&#xD;
          -  STEMI within 7 days or total CK &gt; 2 times the upper limit of normal prior to the CABG&#xD;
             procedure.&#xD;
&#xD;
          -  Both enrolled grafts will feed non-viable myocardial territory.&#xD;
&#xD;
          -  Diffuse atherosclerotic disease (&gt; 70%) distal to either of the enrolled target&#xD;
             coronary arteries.&#xD;
&#xD;
          -  Randomized Cohort: By visual estimate, the target coronary artery diameter of both the&#xD;
             right coronary system and left circumflex system must be within 1.5mm of each other.&#xD;
&#xD;
          -  Planned endarterectomy of the target coronary artery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars Englberger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bern</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Puskas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rebecca Wetterling</last_name>
    <phone>763-235-3540</phone>
    <email>clinical@kipsbaymedical.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Omar Lattouf, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Heart Center</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alan Wolfe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic / St. Mary's Hospital</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Lyle Joyce, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Valley Hospital</name>
      <address>
        <city>Ridgewood</city>
        <state>New Jersey</state>
        <zip>07450</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kimberly Michel, RN</last_name>
      <phone>201-447-8000</phone>
      <phone_ext>2745</phone_ext>
    </contact>
    <investigator>
      <last_name>Juan Grau, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nirav Patel, MD</last_name>
    </contact>
    <investigator>
      <last_name>Nirav Patel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>General University Hospital</name>
      <address>
        <city>Prague</city>
        <country>Czech Republic</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jaroslav Lindner, MD</last_name>
      <phone>+420 224 962 709</phone>
    </contact>
    <investigator>
      <last_name>Jaroslav Lindner, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital na Homolce</name>
      <address>
        <city>Prague</city>
        <country>Czech Republic</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ivo Skalsky, MD</last_name>
      <phone>+420257273209</phone>
    </contact>
    <investigator>
      <last_name>Ivo Skalsky, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital Kralovske Vinohrady</name>
      <address>
        <city>Prague</city>
        <country>Czech Republic</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>C.H.U. Dupuytren</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Marc Laskar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bordeaux University Hospital</name>
      <address>
        <city>Pessac</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Louis Labrousse, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lancisi Hospital</name>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Rescigno, MD</last_name>
    </contact>
    <investigator>
      <last_name>Giuseppe Rescigno, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Heart Hospital - G. Monasterio Tuscany Foundation for Health &amp; Research</name>
      <address>
        <city>Massa</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Marco Solinas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michele Murzi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Erwin Tan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital of Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Lars Englberger, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Brompton Hospital</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Anthony DeSouza, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Czech Republic</country>
    <country>France</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>February 17, 2015</last_update_submitted>
  <last_update_submitted_qc>February 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CABG</keyword>
  <keyword>SVG</keyword>
  <keyword>nitinol mesh</keyword>
  <keyword>external saphenous vein graft support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 5, 2015</submitted>
    <returned>October 26, 2015</returned>
    <submitted>June 28, 2016</submitted>
    <returned>August 9, 2016</returned>
  </pending_results>
  <!-- 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/NCT01676376
org study id: 11016
nct id: NCT01676376
lead sponsor: 
has dmc: Yes
Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate
      feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an
      external vein support device for use over saphenous vein grafts during coronary artery bypass
      surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh
      (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study
      subject will receive one SVG with the eSVS Mesh.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MACE
time frame: 30 days
description: The rate of major adverse coronary events (MACE) defined as the rate of the composite of total mortality, MI (Q wave and non Q wave), and/or coronary target vessel revascularization (percutaneous coronary intervention or CABG).
measure: SVG patency determined by angiography
time frame: 6 months
description: Angiographic patency rate of the enrolled grafts defined as < 50% stenosis.
measure: Technical success implanting eSVS Mesh
time frame: intra-operative
description: Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG.
measure: MACCE and mediastinitis
time frame: 5 years
description: MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months.
measure: SVG patency determined by angiography
time frame: 6 months
description: Angiographic patency rate of the enrolled grafts defined as < 75%.
measure: Plaque burden
time frame: 6 months
description: Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study).
arm group label: eSVS Mesh treated saphenous vein graft
arm group type: Active Comparator
description: Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.
arm group label: Control saphenous vein graft
arm group type: Sham Comparator
description: Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.
arm group label: Single Vessel Treatment
arm group type: Active Comparator
description: Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.
intervention type: Device
intervention name: eSVS Mesh treated saphenous vein graft
description: During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.
arm group label: Single Vessel Treatment
arm group label: eSVS Mesh treated saphenous vein graft
intervention type: Other
intervention name: Control saphenous vein graft
description: During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.
arm group label: Control saphenous vein graft
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
last name: Lars Englberger, MD
role: Principal Investigator
affiliation: University of Bern
last name: John Puskas, MD
role: Principal Investigator
affiliation: Emory University
last name: Rebecca Wetterling
phone: 763-235-3540
email: clinical@kipsbaymedical.com
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: Czech Republic
country: France
country: Italy
country: Netherlands
country: Switzerland
country: United Kingdom
country: United States
country: Germany
responsible party type: Sponsor
mesh term: Atherosclerosis
submitted: October 5, 2015
returned: October 26, 2015
submitted: June 28, 2016
returned: August 9, 2016