<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/NCT02983721</url>
  </required_header>
  <id_info>
    <org_study_id>car003421</org_study_id>
    <secondary_id>PG thesis 003421</secondary_id>
    <nct_id>NCT02983721</nct_id>
  </id_info>
  <brief_title>Trans Radial Versus Transfemoral Route for Coronary Angiography</brief_title>
  <official_title>Comparison Between Transradial and Transfemoral Routes of Coronary Angiography and Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheri Kashmir Institute of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheri Kashmir Institute of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to assess and compare the feasibility, success and safety of&#xD;
      Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic&#xD;
      coronary angiography and coronary interventions, in terms of procedural time, access time,&#xD;
      fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital,&#xD;
      Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of&#xD;
      vessel, MACE, Stroke and others.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: PCI has been done traditionally through transfemoral route. But now transradial&#xD;
      and transbrachial routes are also coming up in practice. We compared transradial versus&#xD;
      transfemoral routes for ease of operability, time for procedure, complications, and failure&#xD;
      rates through a prospective study. Methods: 400 Patients admitted in department of cardiology&#xD;
      for percutaneous interventions were enrolled in the study. 200 patients were assigned to each&#xD;
      group randomly. A single team did all the procedures. Pre procedure, intra procedure and post&#xD;
      procedure data of all the patients was collected, tabulated and analysed properly.&#xD;
&#xD;
      The variables studied include Access time ,Fluoroscopy time and overall procedure time, post&#xD;
      procedure complications( ecchymosis ,Thrombophelibites, Hematoma, procedure access bleed),&#xD;
      Failure rates,post procedure myocardial infarction, stroke, acute renal failure and&#xD;
      infections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Access time</measure>
    <time_frame>4 years</time_frame>
    <description>Access time for the procedures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>4 years</time_frame>
    <description>measure of radiation exposure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procedure time</measure>
    <time_frame>4 years</time_frame>
    <description>time taken to do the full procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hospital stay</measure>
    <time_frame>4 years</time_frame>
    <description>time period the patient stayed in the hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hematoma</measure>
    <time_frame>4 years</time_frame>
    <description>hematoma development at the site of puncture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pseudoaneurysm</measure>
    <time_frame>4 years</time_frame>
    <description>local complication at the access site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bleeding</measure>
    <time_frame>4 years</time_frame>
    <description>at the access site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Access site failure</measure>
    <time_frame>4 years</time_frame>
    <description>failure to gain access for the procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Transfemoral</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>in case of transfemoral approach our preference was to use right femoral route. The groin was prepared and draped and the site was punctured for femoral access after anesthetizing the skin with 2-4 ml of 1% lignocaine. Once the femoral puncture was done 6F sheath of Cordis variety was introduced and 6F Judkins, catheter was introduced and it was guided under fluoroscopic guidance through the aortic route.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transradial</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Our preference was to use the right radial and right femoral routes as they are nearest to operator while facing cardiac monitors, in our hospital. For the radial approach, the wrist was sterilized and draped in usual fashion. Hyperextension over an arm board was done and skin over the puncture site was anesthetized with 2 - 3 ml of 1% lignocaine. A small scaled incision was performed 1 cm proximal to styloid process of radius where arterial pulse was best felt. The radial artery was punctured with a 21 G needle and 6 F sheath (Cardis, Terumo) were introduced into the artery, using Seldinger technique. All patients received verapamil (5mg) to reduce radial artery spasm. Heparin (weight adjusted) was used only in PCIs to prevent artery occlusion and not in elective diagnostic coronary studies. Long 0.038 Terumo guide wire was used under fluoroscopic guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transradial</intervention_name>
    <description>transradial route for coronary angiography and PCI</description>
    <arm_group_label>Transfemoral</arm_group_label>
    <arm_group_label>Transradial</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transfemoral</intervention_name>
    <description>transfemoral route for coronary angiography and PCI</description>
    <arm_group_label>Transfemoral</arm_group_label>
    <arm_group_label>Transradial</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnostic angiography of coronary vessels, PCI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with impaired renal function tests.&#xD;
&#xD;
               -  Lack of informed consent.&#xD;
&#xD;
               -  Severe infection.&#xD;
&#xD;
               -  Previous contrast allergy.&#xD;
&#xD;
               -  Severe intrinsic/iatrogenic caogulopathy INR&gt;2.&#xD;
&#xD;
               -  Abnormal modified Allen's test.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fayaz Bhat, MBBS, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Ministry of Health, Jammu and Kashmir, India.</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheri Kashmir Institute of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Khalid Changal</investigator_full_name>
    <investigator_title>Principal Investigator</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>Yes</sharing_ipd>
    <ipd_description>can be shared by email</ipd_description>
  </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/NCT02983721
org study id: car003421
secondary id: PG thesis 003421
nct id: NCT02983721
lead sponsor: 
has dmc: Yes
The purpose of this study was to assess and compare the feasibility, success and safety of
      Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic
      coronary angiography and coronary interventions, in terms of procedural time, access time,
      fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital,
      Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of
      vessel, MACE, Stroke and others.
Background: PCI has been done traditionally through transfemoral route. But now transradial
      and transbrachial routes are also coming up in practice. We compared transradial versus
      transfemoral routes for ease of operability, time for procedure, complications, and failure
      rates through a prospective study. Methods: 400 Patients admitted in department of cardiology
      for percutaneous interventions were enrolled in the study. 200 patients were assigned to each
      group randomly. A single team did all the procedures. Pre procedure, intra procedure and post
      procedure data of all the patients was collected, tabulated and analysed properly.

      The variables studied include Access time ,Fluoroscopy time and overall procedure time, post
      procedure complications( ecchymosis ,Thrombophelibites, Hematoma, procedure access bleed),
      Failure rates,post procedure myocardial infarction, stroke, acute renal failure and
      infections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Access time
time frame: 4 years
description: Access time for the procedures
measure: Fluoroscopy time
time frame: 4 years
description: measure of radiation exposure
measure: Procedure time
time frame: 4 years
description: time taken to do the full procedure
measure: hospital stay
time frame: 4 years
description: time period the patient stayed in the hospital
measure: hematoma
time frame: 4 years
description: hematoma development at the site of puncture
measure: pseudoaneurysm
time frame: 4 years
description: local complication at the access site
measure: bleeding
time frame: 4 years
description: at the access site
measure: Access site failure
time frame: 4 years
description: failure to gain access for the procedure
arm group label: Transfemoral
arm group type: Active Comparator
description: in case of transfemoral approach our preference was to use right femoral route. The groin was prepared and draped and the site was punctured for femoral access after anesthetizing the skin with 2-4 ml of 1% lignocaine. Once the femoral puncture was done 6F sheath of Cordis variety was introduced and 6F Judkins, catheter was introduced and it was guided under fluoroscopic guidance through the aortic route.
arm group label: Transradial
arm group type: Active Comparator
description: Our preference was to use the right radial and right femoral routes as they are nearest to operator while facing cardiac monitors, in our hospital. For the radial approach, the wrist was sterilized and draped in usual fashion. Hyperextension over an arm board was done and skin over the puncture site was anesthetized with 2 - 3 ml of 1% lignocaine. A small scaled incision was performed 1 cm proximal to styloid process of radius where arterial pulse was best felt. The radial artery was punctured with a 21 G needle and 6 F sheath (Cardis, Terumo) were introduced into the artery, using Seldinger technique. All patients received verapamil (5mg) to reduce radial artery spasm. Heparin (weight adjusted) was used only in PCIs to prevent artery occlusion and not in elective diagnostic coronary studies. Long 0.038 Terumo guide wire was used under fluoroscopic guidance.
intervention type: Procedure
intervention name: transradial
description: transradial route for coronary angiography and PCI
arm group label: Transfemoral
arm group label: Transradial
intervention type: Procedure
intervention name: Transfemoral
description: transfemoral route for coronary angiography and PCI
arm group label: Transfemoral
arm group label: Transradial
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Fayaz Bhat, MBBS, MD
role: Study Chair
affiliation: Ministry of Health, Jammu and Kashmir, India.
responsible party type: Principal Investigator
investigator affiliation: Sheri Kashmir Institute of Medical Sciences
investigator full name: Khalid Changal
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
sharing ipd: Yes
ipd description: can be shared by email