<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/NCT01697176</url>
  </required_header>
  <id_info>
    <org_study_id>OPTION</org_study_id>
    <nct_id>NCT01697176</nct_id>
  </id_info>
  <brief_title>Optimal Improvement of Vein Graft Patency Long Term by the Implementation Of Novel Endoscopic Harvesting Techniques</brief_title>
  <acronym>OPTION</acronym>
  <official_title>A 1-year Prospective, Multicenter, Non-Randomized, Observational, Study to Evaluate Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiopulmonary Research Science and Technology Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maquet Cardiovascular</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardiopulmonary Research Science and Technology Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study of lone Coronary Artery Bypass Grafting procedures with&#xD;
      endoscopic vein graft harvesting using best harvesting practices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, non-randomized, observational study of 100 patients who&#xD;
      will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone&#xD;
      Coronary Artery Bypass Graft (CABG) procedures with endoscopic vein harvesting using best&#xD;
      harvesting practices, defined as: systemic heparinization prior to vein manipulation,&#xD;
      standardization of vein graft harvesting techniques, pressure limiting syringe and 3 month&#xD;
      use of dual anti-platelet therapy. Patients will undergo a CT angiography at 30 days and 12&#xD;
      months to assess vein graft patency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques</measure>
    <time_frame>12 months</time_frame>
    <description>To demonstrate improved vein graft patency rates at 12 months for endoscopically harvest saphenous vein grafts by employment of modifications to existing techniques in vein graft handling during harvests. Vein graft patency will be measured at 30 days post CABG and at one year post CABG as evaluated by cardiac CT angiography or cardiac catheterization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OPTION</measure>
    <time_frame>12 months</time_frame>
    <description>To develop a standardized approach for harvesting, handling and preparing vein grafts in the endoscopic approach. By capturing the following:&#xD;
Incidence of vein graft failure at the time of initial CABG as evaluated by transit time graft flow measurements&#xD;
Incidence of vein graft failure at post-operative day 30 as evaluated by cardiac CT angiography or cardiac catheterization&#xD;
Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by:&#xD;
Harvested vessel&#xD;
vein graft destinations&#xD;
vein graft quality</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Coronary Artery Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Isolated CABG&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18 and able to provide consent&#xD;
&#xD;
          -  Eligible for endoscopic vein harvesting&#xD;
&#xD;
          -  Minimum of two non sequential vein grafts&#xD;
&#xD;
          -  Willing to comply with requirements of protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous CABG&#xD;
&#xD;
          -  Previous or concomitant valve surgery&#xD;
&#xD;
          -  Any other concomitant cardiac procedure other than surgical ablation or incidental PFO&#xD;
             repair&#xD;
&#xD;
          -  Intolerance to Iodine or IV contrast that cannot be controlled with pre-medication&#xD;
&#xD;
          -  Renal insufficiency with GFR measurement ≤ 40, unless dialysis dependent&#xD;
&#xD;
          -  Abnormal platelet level defined as Plt Count &gt;400,000&#xD;
&#xD;
          -  Abnormal platelet function (hypercoagulable state) as evidenced by TEG testing&#xD;
&#xD;
          -  Allergy to or presence of a condition that the investigator feels may prevent safe&#xD;
             administration of ASA or Plavix post-operatively.&#xD;
&#xD;
          -  Patient has a co-morbid condition that in the opinion of the investigator poses undue&#xD;
             risk for successful endovascular harvesting of the vein&#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>David Moore, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Heart Hospital Baylor Plano</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael J Mack, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiopulmonary Research Science and Technology Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRSTI/Medical City Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Hospital Baylor Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>February 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>October 21, 2014</last_update_submitted>
  <last_update_submitted_qc>October 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 22, 2014</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>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01697176
org study id: OPTION
nct id: NCT01697176
lead sponsor: 
collaborator: 
has dmc: No
This is an observational study of lone Coronary Artery Bypass Grafting procedures with
      endoscopic vein graft harvesting using best harvesting practices.
This is a prospective, multi-center, non-randomized, observational study of 100 patients who
      will undergo routine coronary artery bypass grafting. Eligible candidates will undergo lone
      Coronary Artery Bypass Graft (CABG) procedures with endoscopic vein harvesting using best
      harvesting practices, defined as: systemic heparinization prior to vein manipulation,
      standardization of vein graft harvesting techniques, pressure limiting syringe and 3 month
      use of dual anti-platelet therapy. Patients will undergo a CT angiography at 30 days and 12
      months to assess vein graft patency.
observational model: Cohort
time perspective: Prospective
measure: Optimal Improvement of Vein Graft Patency Long Term by the Implementation of Novel Endoscopic Harvesting Techniques
time frame: 12 months
description: To demonstrate improved vein graft patency rates at 12 months for endoscopically harvest saphenous vein grafts by employment of modifications to existing techniques in vein graft handling during harvests. Vein graft patency will be measured at 30 days post CABG and at one year post CABG as evaluated by cardiac CT angiography or cardiac catheterization.
measure: OPTION
time frame: 12 months
description: To develop a standardized approach for harvesting, handling and preparing vein grafts in the endoscopic approach. By capturing the following:
Incidence of vein graft failure at the time of initial CABG as evaluated by transit time graft flow measurements
Incidence of vein graft failure at post-operative day 30 as evaluated by cardiac CT angiography or cardiac catheterization
Incidence of vein graft failure at each interval (30 day and 12 month) as categorized by:
Harvested vessel
vein graft destinations
vein graft quality
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Moore, MD
role: Principal Investigator
affiliation: The Heart Hospital Baylor Plano
last name: Michael J Mack, MD
role: Principal Investigator
affiliation: Cardiopulmonary Research Science and Technology Institute
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease