<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/NCT03292367</url>
  </required_header>
  <id_info>
    <org_study_id>LeDRA</org_study_id>
    <nct_id>NCT03292367</nct_id>
  </id_info>
  <brief_title>The Procedural Success and Complication Rate of the Left Distal Radial Approach</brief_title>
  <official_title>The Procedural Success and Complication Rate of the Left Distal Radial Approach for Coronary Angiography and Percutaneous Coronary Intervention. Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wonju Severance Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Samjin Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Wonju Severance Christian Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Left distal transradial approach (ldTRA) can be an attractive alternative route for left&#xD;
      radial and right radial artery. Recently, Ferdinand Kiemeneij reported the feasibility and&#xD;
      safety of the use of ldTRA. But, there is few studies focused on this issue. Therefore, the&#xD;
      purpose of this prospective observational study is to assess the feasibility and safety of&#xD;
      the ldTRA for CAG and PCI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Femoral artery has been traditionally used as a standard route for coronary angiography (CAG)&#xD;
      and percutaneous coronary intervention (PCI). Recently, the frequency of use of transradial&#xD;
      approach (TRA) is increasing. TRA has several advantages in terms of more comfortable&#xD;
      feeling, immediate ambulation, less bleeding complication and decreased mortality rate&#xD;
      compared to transfemoral approach (TFA). 2015 ESC guidelines recommend to use of radial&#xD;
      artery in order to reduce bleeding complication and mortality. But, most operators tend to&#xD;
      prefer right radial approach (RRA) for the access route, because they are usually&#xD;
      right-handed and feel more comfortable in the use of right radial artery. Particularly when&#xD;
      the patient is obese or the operator's height is short or has a herniated disc on neck or&#xD;
      waist, the discomfort may become greater.&#xD;
&#xD;
      In other hand, left radial approach (LRA) have several advantages. Left brachial artery or&#xD;
      subclavian artery is less tortuous than right side. The manipulation of catheter is similar&#xD;
      with femoral approach. Also, since most patients are right-handed, compression after LRA&#xD;
      leads to greater comfort for the patient.&#xD;
&#xD;
      In comparison to the convenience of the patient and procedure, comparative studies on&#xD;
      clinical outcomes showed similar results for both RRA and LRA. But LRA may be more at risk&#xD;
      for radiation. This is because the operator has to lean more toward the patient for the&#xD;
      procedure, which can result in increased radiation exposure.&#xD;
&#xD;
      Recently, the left distal radial artery approach (ldTRA) has been introduced as an&#xD;
      alternative to feasibility and safety while satisfying both patient and operator convenience.&#xD;
      The left palm is positioned facing the floor at the left groin. Left distal radial artery is&#xD;
      punctured at the level of anatomical snuffbox. Ferdinand Kiemeneij reported that CAG and PCI&#xD;
      were successfully performed in 70 patients.&#xD;
&#xD;
      There are no nerve and vein in the anatomical snuffbox. And distal radial artery is located&#xD;
      at superficial area. So, there may be potential advantage to reduce bleeding complication and&#xD;
      nerve injury. Moreover, ldTRA can be an alternative method for the patient requiring&#xD;
      arteriovenous fistula and for the patient preparing coronary artery bypass graft because&#xD;
      there is no injury of left radial artery.&#xD;
&#xD;
      The patients have potential bleeding risk because dual antiplatelet agents (aspirin 300mg and&#xD;
      clopidogrel 300mg) and more than 3,000 units of unfractionated heparin should be loaded for&#xD;
      CAG and PCI. The effective hemostasis method has not yet been established after ldTRA.&#xD;
      Therefore, it is important to establish effective hemostasis method and timing. However, like&#xD;
      TRA, ldTRA requires a learning curve to be mastered, and it cannot be performed if the pulse&#xD;
      is not palpable. There are few studies related to ldTRA. The purpose of this prospective&#xD;
      observational study is to assess the feasibility and safety of the ldTRA for CAG and PCI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Actual">February 24, 2018</completion_date>
  <primary_completion_date type="Actual">February 19, 2018</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>Success rate of coronary angiography</measure>
    <time_frame>1 year</time_frame>
    <description>The frequency of success rate of coronary angiography (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Success rate of percutaneous coronary intervention</measure>
    <time_frame>1 year</time_frame>
    <description>The frequency of success rate of percutaneous coronary intervention (%)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success rate of puncture of left distal radial artery</measure>
    <time_frame>1 year</time_frame>
    <description>The frequency rate of successful puncture of left distal radial artery (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diameter of left distal radial artery</measure>
    <time_frame>1 year</time_frame>
    <description>Measured by ultrasonography before procedure (mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemostasis duration at the puncture site</measure>
    <time_frame>1 year</time_frame>
    <description>Hemostasis duration after procedure (minute)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications at the puncture site</measure>
    <time_frame>1 year</time_frame>
    <description>The frequency rate of complications at the puncture site (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>1 year</time_frame>
    <description>Procedure time including coronary angiograph and percutaneous coronary intervention, if performed (minute)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exposure time of radiation</measure>
    <time_frame>1 year</time_frame>
    <description>Total exposure time of radiation during procedure (minute)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose of radiation</measure>
    <time_frame>1 year</time_frame>
    <description>Dose of radiation during procedure (Gy-cm2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The degree of patient's satisfaction</measure>
    <time_frame>1 year</time_frame>
    <description>Questionnaire using visual analogue scale for the pain and satisfaction of overall procedure especially focused on the left distal radial approach (Maximum 10 score, Minimum 0 score)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Radial Artery Injury at Wrist and Hand Level</condition>
  <arm_group>
    <arm_group_label>ldTRA</arm_group_label>
    <description>Patients who are planned to perform coronary angiography will be enrolled via left distal radial artery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ldTRA</intervention_name>
    <description>After puncture of left distal radial artery, coronary angiography and percutaneous coronary intervention, if needed, will be performed.</description>
    <arm_group_label>ldTRA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        During 1 year, more than 200 patients who are needed to perform coronary angiography or&#xD;
        percutaneous coronary intervention will be prospectively enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 20 years old requiring coronary angiography&#xD;
&#xD;
          -  Patients who are palpable left distal radial artery&#xD;
&#xD;
          -  Patients who agreed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not palpable left distal radial artery&#xD;
&#xD;
          -  Patients who are positive in Modified Allen's test (suspicious of occlusion of ulnar&#xD;
             artery)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients who are not appropriate for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seung-Hwan Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital</name>
      <address>
        <city>Wonju</city>
        <state>Gangwon-do</state>
        <zip>26426</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.</citation>
    <PMID>28506941</PMID>
  </results_reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wonju Severance Christian Hospital</investigator_affiliation>
    <investigator_full_name>Seung Hwan Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery 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>


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/NCT03292367
org study id: LeDRA
nct id: NCT03292367
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Left distal transradial approach (ldTRA) can be an attractive alternative route for left
      radial and right radial artery. Recently, Ferdinand Kiemeneij reported the feasibility and
      safety of the use of ldTRA. But, there is few studies focused on this issue. Therefore, the
      purpose of this prospective observational study is to assess the feasibility and safety of
      the ldTRA for CAG and PCI.
Femoral artery has been traditionally used as a standard route for coronary angiography (CAG)
      and percutaneous coronary intervention (PCI). Recently, the frequency of use of transradial
      approach (TRA) is increasing. TRA has several advantages in terms of more comfortable
      feeling, immediate ambulation, less bleeding complication and decreased mortality rate
      compared to transfemoral approach (TFA). 2015 ESC guidelines recommend to use of radial
      artery in order to reduce bleeding complication and mortality. But, most operators tend to
      prefer right radial approach (RRA) for the access route, because they are usually
      right-handed and feel more comfortable in the use of right radial artery. Particularly when
      the patient is obese or the operator's height is short or has a herniated disc on neck or
      waist, the discomfort may become greater.

      In other hand, left radial approach (LRA) have several advantages. Left brachial artery or
      subclavian artery is less tortuous than right side. The manipulation of catheter is similar
      with femoral approach. Also, since most patients are right-handed, compression after LRA
      leads to greater comfort for the patient.

      In comparison to the convenience of the patient and procedure, comparative studies on
      clinical outcomes showed similar results for both RRA and LRA. But LRA may be more at risk
      for radiation. This is because the operator has to lean more toward the patient for the
      procedure, which can result in increased radiation exposure.

      Recently, the left distal radial artery approach (ldTRA) has been introduced as an
      alternative to feasibility and safety while satisfying both patient and operator convenience.
      The left palm is positioned facing the floor at the left groin. Left distal radial artery is
      punctured at the level of anatomical snuffbox. Ferdinand Kiemeneij reported that CAG and PCI
      were successfully performed in 70 patients.

      There are no nerve and vein in the anatomical snuffbox. And distal radial artery is located
      at superficial area. So, there may be potential advantage to reduce bleeding complication and
      nerve injury. Moreover, ldTRA can be an alternative method for the patient requiring
      arteriovenous fistula and for the patient preparing coronary artery bypass graft because
      there is no injury of left radial artery.

      The patients have potential bleeding risk because dual antiplatelet agents (aspirin 300mg and
      clopidogrel 300mg) and more than 3,000 units of unfractionated heparin should be loaded for
      CAG and PCI. The effective hemostasis method has not yet been established after ldTRA.
      Therefore, it is important to establish effective hemostasis method and timing. However, like
      TRA, ldTRA requires a learning curve to be mastered, and it cannot be performed if the pulse
      is not palpable. There are few studies related to ldTRA. The purpose of this prospective
      observational study is to assess the feasibility and safety of the ldTRA for CAG and PCI.
observational model: Cohort
time perspective: Prospective
measure: Success rate of coronary angiography
time frame: 1 year
description: The frequency of success rate of coronary angiography (%)
measure: Success rate of percutaneous coronary intervention
time frame: 1 year
description: The frequency of success rate of percutaneous coronary intervention (%)
measure: Success rate of puncture of left distal radial artery
time frame: 1 year
description: The frequency rate of successful puncture of left distal radial artery (%)
measure: Diameter of left distal radial artery
time frame: 1 year
description: Measured by ultrasonography before procedure (mm)
measure: Hemostasis duration at the puncture site
time frame: 1 year
description: Hemostasis duration after procedure (minute)
measure: Complications at the puncture site
time frame: 1 year
description: The frequency rate of complications at the puncture site (%)
measure: Procedure time
time frame: 1 year
description: Procedure time including coronary angiograph and percutaneous coronary intervention, if performed (minute)
measure: Exposure time of radiation
time frame: 1 year
description: Total exposure time of radiation during procedure (minute)
measure: Dose of radiation
time frame: 1 year
description: Dose of radiation during procedure (Gy-cm2)
measure: The degree of patient's satisfaction
time frame: 1 year
description: Questionnaire using visual analogue scale for the pain and satisfaction of overall procedure especially focused on the left distal radial approach (Maximum 10 score, Minimum 0 score)
arm group label: ldTRA
description: Patients who are planned to perform coronary angiography will be enrolled via left distal radial artery
intervention type: Procedure
intervention name: ldTRA
description: After puncture of left distal radial artery, coronary angiography and percutaneous coronary intervention, if needed, will be performed.
arm group label: ldTRA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Seung-Hwan Lee, MD, PhD
role: Principal Investigator
affiliation: Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine
facility: 
country: Korea, Republic of
citation: Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.
PMID: 28506941
responsible party type: Principal Investigator
investigator affiliation: Wonju Severance Christian Hospital
investigator full name: Seung Hwan Lee
investigator title: Professor
mesh term: Coronary Artery Disease
sharing ipd: No