xml: <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/NCT06014047</url>
    </required_header>
    <id_info>
      <org_study_id>2023-2109</org_study_id>
      <nct_id>NCT06014047</nct_id>
    </id_info>
    <brief_title>Radial Artery Versus No-touch Vein Graft</brief_title>
    <official_title>Multicenter Randomized Trial to Compare the Graft Patency Between Radial Artery and No-touch Vein in Coronary Artery Bypass Graft Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China National Center for Cardiovascular Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China National Center for Cardiovascular Diseases</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study evaluates the short-term and long-term patency of the radial artery and the&#xD;
        No-touch vein in patients undergoing isolated on-pump/off-pump coronary artery bypass graft&#xD;
        (CABG) surgery. A total of at least 774 patients undergoing isolated on-pump/off-pump CABG&#xD;
        will be consecutively recruited from Fuwai Hospital and randomly assigned to receive radial&#xD;
        artery or No-touch saphenous vein as their second graft. All participants will be invited for&#xD;
        clinical follow-up and 64-slice multislice computed tomography angiography (MSCTA) analysis&#xD;
        at 3 months and 12 months post-operatively.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        CABG is still the treatment of choice for ischemic heart disease. However, restenosis or&#xD;
        occlusion may occur to graft vessels, leading to postoperative myocardial ischemia and&#xD;
        subsequent clinical events. Long-term angiographic follow-up demonstrated that vein graft&#xD;
        restenosis and occlusion are common among those receiving CABG, with a vein graft patency of&#xD;
        less than 50% at 15 years postoperatively.&#xD;
  &#xD;
        A novel approach to harvesting the vein is called &quot;No-touch&quot; technique (NT), which can avoid&#xD;
        mechanical damage to the vein wall. Previous studies showed that No-touch saphenous vein&#xD;
        grafts (NT-SVG) has a 96.3% postoperative graft patency rate at 12 months, compared to 93.5%&#xD;
        of conventional saphenous vein grafts (con-SVGs). Thus, the No-touch technique can&#xD;
        significantly reduce postoperative graft occlusion. Radial artery as an arterial material for&#xD;
        CABG surgery has a better long-term patency than con-SVG, up to 83% at 10 years. Using radial&#xD;
        artery as the second graft for CABG may provide additional clinical benefit. However, the&#xD;
        risk of perioperative vasospasm and graft occlusion due to competitive blood flow limit the&#xD;
        using of radial artery. Therefore, only the No-touch vein and the radial artery can improve&#xD;
        the graft patency. Only one RCT compared the RA and NT-vein, and this study is limited by&#xD;
        irregular post-operative management and small sample size from single center.&#xD;
  &#xD;
        This prospective single-center study aims to compare the short-term and long-term graft&#xD;
        patency between the No-touch vein and the radial artery. This study will consecutively enroll&#xD;
        at least 774 patients undergoing isolated on-pump/off-pump CABG. After obtaining informed&#xD;
        written consent, participants will be randomly allocated to either the No-touch or the radial&#xD;
        artery group. At baseline, participants will be interviewed to collect detailed information&#xD;
        about on demographics, socioeconomic status, cardiovascular risk factors, clinical&#xD;
        characteristics, treatments, in-hospital outcomes, general and disease-specific quality of&#xD;
        life, function and mental status. During the follow-ups, the investigators will collect&#xD;
        information about clinical outcomes events, long-term treatments, function, quality of life,&#xD;
        symptoms, and medical care during the recovery period. All participants will be invited for&#xD;
        64-slice multi-slice computed tomography angiography (MSCTA) analysis at 3 months and 12&#xD;
        months post-operatively for graft patency evaluation.&#xD;
  &#xD;
        The data adjudicators and CT reviewers will be blinded to the study. Due to the nature of&#xD;
        this study, the operating surgeons, anesthetists and other operative room staff will not be&#xD;
        blind in this study. Owing to the use of radial artery need approved by the participant, so&#xD;
        participants will also not be blind in this study,&#xD;
  &#xD;
        By comparing the short-term and long-term graft patency between the No-touch vein and radial&#xD;
        artery groups, this study will contribute major evidence of the possible superiority between&#xD;
        two different grafts, so as to improve patient outcomes after CABG surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2030</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2026</primary_completion_date>
    <phase>N/A</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>Prevalence of graft patency</measure>
      <time_frame>12 months after procedure</time_frame>
      <description>All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Prevalence of graft patency</measure>
      <time_frame>3 months, 3 years and 5 years after procedure</time_frame>
      <description>All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall major adverse cardiac or cerebrovascular events (MACCE) rate</measure>
      <time_frame>3 months, 12 months, 3 years and 5 years after procedure</time_frame>
      <description>MACCE includes death, myocardial infarction, stroke and/or repeat revascularization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac death</measure>
      <time_frame>3 months, 12 months, 3 years and 5 years after procedure</time_frame>
      <description>Death from any heart disease</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Documented non-lethal myocardial infarction</measure>
      <time_frame>3 months, 12 months, 3 years and 5 years after procedure</time_frame>
      <description>Myocardial infarction is defined according to the most recent guideline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke</measure>
      <time_frame>3 months, 12 months, 3 years and 5 years after procedure</time_frame>
      <description>An acute symptomatic episode of focal or global neurological dysfunction caused by brain, spinal, or retinal vascular injury as a result of hemorrhage or infarction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Target lesion revascularization</measure>
      <time_frame>3 months, 12 months, 3 years and 5 years after procedure</time_frame>
      <description>CABG or percutaneous coronary intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recurrence of Angina</measure>
      <time_frame>3 months, 12 months, 3 years and 5 years after procedure</time_frame>
      <description>Recurrence of Angina</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">774</enrollment>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>No-Touch vein</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>No-touch vein group has two No-touch saphenous vein grafts, anastomose to the right coronary or left coronary system. All patients also acquired LITA-LAD anastomosis to complete the revascularization.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Radial artery</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Radial artery group has one radial artery graft and one conventional saphenous vein graft, anastomose to the right coronary or left coronary system basing on surgeons' decision. All patients also acquired LITA-LAD anastomosis to complete the revascularization.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>No-touch vein graft</intervention_name>
      <description>Two No-touch saphenous vein grafts anastomose to the right coronary and left coronary system. All participants also acquired Left intrathoracic artery(LITA)-left anterior decending artery(LAD) anastomosis to complete the revascularization.</description>
      <arm_group_label>No-Touch vein</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Radial artery graft</intervention_name>
      <description>One radial artery graft and one conventional saphenous vein graft anastomose to the right coronary or left coronary system basing on surgeons' decision. All participants also acquired Left intrathoracic artery(LITA)-left anterior decending artery(LAD) anastomosis to complete the revascularization.</description>
      <arm_group_label>Radial artery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age more than 18 years old&#xD;
  &#xD;
            -  First time undergo isolated CABG surgery&#xD;
  &#xD;
            -  Severe three-vessel disease (LAD, LCX, RCA lesion with more than 75% stenosis)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Urgent or Redo CABG surgery&#xD;
  &#xD;
            -  Concomitant cardiac or vascular procedures (i.e. valve repair or replacement, Morrow&#xD;
               procedure)&#xD;
  &#xD;
            -  A positive Allen test, radial artery plaque on ultrasound or a history of vasculitis&#xD;
               or Raynaud's syndrome&#xD;
  &#xD;
            -  Varicose great saphenous vein or venous tortuosity and judged as can not be used in&#xD;
               operation by surgeons&#xD;
  &#xD;
            -  Known allergy to radiographic contrast media&#xD;
  &#xD;
            -  Planed endarterectomy of coronary artery before surgery&#xD;
  &#xD;
            -  Malignant tumor or other severe systemic diseases&#xD;
  &#xD;
            -  Combined with other irreversible organ failures&#xD;
  &#xD;
            -  Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer&#xD;
  &#xD;
            -  Participant of other ongoing clinical trials in 30 days.&#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_contact>
      <last_name>Shengshou Hu, M.D.</last_name>
      <phone>+86-10-88398359</phone>
      <email>shengshouhu@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Meice Tian, M.D.</last_name>
      <phone>+8613718863077</phone>
      <email>tianmeice@fuwaihospital.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100037</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Tian M, Wang X, Sun H, Feng W, Song Y, Lu F, Wang L, Wang Y, Xu B, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Yang Y, Guo S, Lu B, Sun Z, Liu K, Zhang C, Wu Y, Xu H, Zhao W, Han C, Zhou X, Wang E, Huo X, Hu S. No-Touch Versus Conventional Vein Harvesting Techniques at 12 Months After Coronary Artery Bypass Grafting Surgery: Multicenter Randomized, Controlled Trial. Circulation. 2021 Oct 5;144(14):1120-1129. doi: 10.1161/CIRCULATIONAHA.121.055525. Epub 2021 Sep 13.</citation>
      <PMID>34510911</PMID>
    </results_reference>
    <results_reference>
      <citation>Nappi F, Bellomo F, Nappi P, Chello C, Iervolino A, Chello M, Acar C. The Use of Radial Artery for CABG: An Update. Biomed Res Int. 2021 Apr 7;2021:5528006. doi: 10.1155/2021/5528006. eCollection 2021.</citation>
      <PMID>33928147</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>coronary artery disease</keyword>
    <keyword>coronary artery bypass grafting</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014047
  org study id: 2023-2109
  nct id: NCT06014047
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study evaluates the short-term and long-term patency of the radial artery and the
        No-touch vein in patients undergoing isolated on-pump/off-pump coronary artery bypass graft
        (CABG) surgery. A total of at least 774 patients undergoing isolated on-pump/off-pump CABG
        will be consecutively recruited from Fuwai Hospital and randomly assigned to receive radial
        artery or No-touch saphenous vein as their second graft. All participants will be invited for
        clinical follow-up and 64-slice multislice computed tomography angiography (MSCTA) analysis
        at 3 months and 12 months post-operatively.
  CABG is still the treatment of choice for ischemic heart disease. However, restenosis or
        occlusion may occur to graft vessels, leading to postoperative myocardial ischemia and
        subsequent clinical events. Long-term angiographic follow-up demonstrated that vein graft
        restenosis and occlusion are common among those receiving CABG, with a vein graft patency of
        less than 50% at 15 years postoperatively.
  
        A novel approach to harvesting the vein is called "No-touch" technique (NT), which can avoid
        mechanical damage to the vein wall. Previous studies showed that No-touch saphenous vein
        grafts (NT-SVG) has a 96.3% postoperative graft patency rate at 12 months, compared to 93.5%
        of conventional saphenous vein grafts (con-SVGs). Thus, the No-touch technique can
        significantly reduce postoperative graft occlusion. Radial artery as an arterial material for
        CABG surgery has a better long-term patency than con-SVG, up to 83% at 10 years. Using radial
        artery as the second graft for CABG may provide additional clinical benefit. However, the
        risk of perioperative vasospasm and graft occlusion due to competitive blood flow limit the
        using of radial artery. Therefore, only the No-touch vein and the radial artery can improve
        the graft patency. Only one RCT compared the RA and NT-vein, and this study is limited by
        irregular post-operative management and small sample size from single center.
  
        This prospective single-center study aims to compare the short-term and long-term graft
        patency between the No-touch vein and the radial artery. This study will consecutively enroll
        at least 774 patients undergoing isolated on-pump/off-pump CABG. After obtaining informed
        written consent, participants will be randomly allocated to either the No-touch or the radial
        artery group. At baseline, participants will be interviewed to collect detailed information
        about on demographics, socioeconomic status, cardiovascular risk factors, clinical
        characteristics, treatments, in-hospital outcomes, general and disease-specific quality of
        life, function and mental status. During the follow-ups, the investigators will collect
        information about clinical outcomes events, long-term treatments, function, quality of life,
        symptoms, and medical care during the recovery period. All participants will be invited for
        64-slice multi-slice computed tomography angiography (MSCTA) analysis at 3 months and 12
        months post-operatively for graft patency evaluation.
  
        The data adjudicators and CT reviewers will be blinded to the study. Due to the nature of
        this study, the operating surgeons, anesthetists and other operative room staff will not be
        blind in this study. Owing to the use of radial artery need approved by the participant, so
        participants will also not be blind in this study,
  
        By comparing the short-term and long-term graft patency between the No-touch vein and radial
        artery groups, this study will contribute major evidence of the possible superiority between
        two different grafts, so as to improve patient outcomes after CABG surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Prevalence of graft patency
  time frame: 12 months after procedure
  description: All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.
  measure: Prevalence of graft patency
  time frame: 3 months, 3 years and 5 years after procedure
  description: All participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.
  measure: Overall major adverse cardiac or cerebrovascular events (MACCE) rate
  time frame: 3 months, 12 months, 3 years and 5 years after procedure
  description: MACCE includes death, myocardial infarction, stroke and/or repeat revascularization
  measure: Cardiac death
  time frame: 3 months, 12 months, 3 years and 5 years after procedure
  description: Death from any heart disease
  measure: Documented non-lethal myocardial infarction
  time frame: 3 months, 12 months, 3 years and 5 years after procedure
  description: Myocardial infarction is defined according to the most recent guideline
  measure: Stroke
  time frame: 3 months, 12 months, 3 years and 5 years after procedure
  description: An acute symptomatic episode of focal or global neurological dysfunction caused by brain, spinal, or retinal vascular injury as a result of hemorrhage or infarction
  measure: Target lesion revascularization
  time frame: 3 months, 12 months, 3 years and 5 years after procedure
  description: CABG or percutaneous coronary intervention
  measure: Recurrence of Angina
  time frame: 3 months, 12 months, 3 years and 5 years after procedure
  description: Recurrence of Angina
  arm group label: No-Touch vein
  arm group type: Experimental
  description: No-touch vein group has two No-touch saphenous vein grafts, anastomose to the right coronary or left coronary system. All patients also acquired LITA-LAD anastomosis to complete the revascularization.
  arm group label: Radial artery
  arm group type: Active Comparator
  description: Radial artery group has one radial artery graft and one conventional saphenous vein graft, anastomose to the right coronary or left coronary system basing on surgeons' decision. All patients also acquired LITA-LAD anastomosis to complete the revascularization.
  intervention type: Procedure
  intervention name: No-touch vein graft
  description: Two No-touch saphenous vein grafts anastomose to the right coronary and left coronary system. All participants also acquired Left intrathoracic artery(LITA)-left anterior decending artery(LAD) anastomosis to complete the revascularization.
  arm group label: No-Touch vein
  intervention type: Procedure
  intervention name: Radial artery graft
  description: One radial artery graft and one conventional saphenous vein graft anastomose to the right coronary or left coronary system basing on surgeons' decision. All participants also acquired Left intrathoracic artery(LITA)-left anterior decending artery(LAD) anastomosis to complete the revascularization.
  arm group label: Radial artery
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shengshou Hu, M.D.
  phone: +86-10-88398359
  email: shengshouhu@yahoo.com
  last name: Meice Tian, M.D.
  phone: +8613718863077
  email: tianmeice@fuwaihospital.org
  facility: 
  country: China
  citation: Tian M, Wang X, Sun H, Feng W, Song Y, Lu F, Wang L, Wang Y, Xu B, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Yang Y, Guo S, Lu B, Sun Z, Liu K, Zhang C, Wu Y, Xu H, Zhao W, Han C, Zhou X, Wang E, Huo X, Hu S. No-Touch Versus Conventional Vein Harvesting Techniques at 12 Months After Coronary Artery Bypass Grafting Surgery: Multicenter Randomized, Controlled Trial. Circulation. 2021 Oct 5;144(14):1120-1129. doi: 10.1161/CIRCULATIONAHA.121.055525. Epub 2021 Sep 13.
  PMID: 34510911
  citation: Nappi F, Bellomo F, Nappi P, Chello C, Iervolino A, Chello M, Acar C. The Use of Radial Artery for CABG: An Update. Biomed Res Int. 2021 Apr 7;2021:5528006. doi: 10.1155/2021/5528006. eCollection 2021.
  PMID: 33928147
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  sharing ipd: No