<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/NCT03265769</url>
  </required_header>
  <id_info>
    <org_study_id>Atadek2017/13</org_study_id>
    <nct_id>NCT03265769</nct_id>
  </id_info>
  <brief_title>Femoral or Radial Approach in Coronary Chronic Total Occlusion</brief_title>
  <official_title>Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial (FORT CTO TRIAL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acibadem University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acibadem University</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>
      Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly&#xD;
      performed using bilateral transfemoral access and 8 French guiding catheters. However,&#xD;
      transfemoral approach (TFA) is associated with higher risk of vascular access complications.5&#xD;
      It has been reported that using transradial approach (TRA) reduces vascular complications and&#xD;
      may be associated with a better clinical outcome. Transradial access is also used in complex&#xD;
      PCI interventions.There is a growing body of evidence regarding the use of this approach also&#xD;
      in CTO procedures. In available literature, all studies comparing TRA vs. TFA in CTO&#xD;
      consisted of single center and single operator experience. Besides, none of them is&#xD;
      randomized. To fill in the gap, we sought to examine the technique and outcomes of&#xD;
      transradial vs. transfemoral CTO PCI in a contemporary multicenter randomized study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All consecutive patients referred for CTO PCI between August 2017 and July 2021 at Acibadem&#xD;
      University Kocaeli Acibadem Hospital, Kocaeli; Erciyes University Medical Faculty, Kayseri;&#xD;
      Istanbul University Cerrahpasa Medical Faculty, Haseki Cardiology Institute; Istanbul;&#xD;
      Memorial Bahcelievler Hospital, Istanbul were screened for enrollment in the study. The&#xD;
      exclusion criteria included: (a) any acute coronary syndrome within 3 months; (b) severe&#xD;
      heart failure issues; (c)severe renal failure (d) failure to provide written informed&#xD;
      consent.The radial access group consisted of patients with single or bi-radial approach. Any&#xD;
      femoral artery puncture was considered a femoral case. For example, a crossover from any&#xD;
      radial to femoral access was considered a femoral case. Procedures were performed by 4&#xD;
      interventional cardiologists, who are dedicated radial operators, at 4 different centers. The&#xD;
      protocol was approved by the institutional review board and all patients provided written&#xD;
      informed consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Actual">July 8, 2021</completion_date>
  <primary_completion_date type="Actual">July 8, 2021</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>Procedural success</measure>
    <time_frame>24 hours</time_frame>
    <description>Technical success without any in-hospital event</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major access site complications</measure>
    <time_frame>24 hours</time_frame>
    <description>Major bleeding, vascular complication requiring intervention and hematomas ≥ 10 cm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">610</enrollment>
  <condition>Chronic Coronary Occlusion</condition>
  <arm_group>
    <arm_group_label>Transradial approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>target vessel revascularization via radial access site is labeled as transradial approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transfemoral approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>target vessel revascularization via femoral access site is labeled as transfemoral approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>radial access site</intervention_name>
    <description>radial route</description>
    <arm_group_label>Transradial approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>femoral access site</intervention_name>
    <description>femoral route</description>
    <arm_group_label>Transfemoral approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient with coronary total occlusion &gt;3 months and indication for intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute coronary syndrome within 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sevket Gorgulu, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Acibadem University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Acibadem University</name>
      <address>
        <city>İstanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haseki Cradiology Institute</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erciyes University</name>
      <address>
        <city>Kayseri</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 10, 2021</last_update_submitted>
  <last_update_submitted_qc>September 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Femoral approach</keyword>
  <keyword>Radial approach</keyword>
  <keyword>Chronic total occlusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Occlusion</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/NCT03265769
org study id: Atadek2017/13
nct id: NCT03265769
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly
      performed using bilateral transfemoral access and 8 French guiding catheters. However,
      transfemoral approach (TFA) is associated with higher risk of vascular access complications.5
      It has been reported that using transradial approach (TRA) reduces vascular complications and
      may be associated with a better clinical outcome. Transradial access is also used in complex
      PCI interventions.There is a growing body of evidence regarding the use of this approach also
      in CTO procedures. In available literature, all studies comparing TRA vs. TFA in CTO
      consisted of single center and single operator experience. Besides, none of them is
      randomized. To fill in the gap, we sought to examine the technique and outcomes of
      transradial vs. transfemoral CTO PCI in a contemporary multicenter randomized study.
All consecutive patients referred for CTO PCI between August 2017 and July 2021 at Acibadem
      University Kocaeli Acibadem Hospital, Kocaeli; Erciyes University Medical Faculty, Kayseri;
      Istanbul University Cerrahpasa Medical Faculty, Haseki Cardiology Institute; Istanbul;
      Memorial Bahcelievler Hospital, Istanbul were screened for enrollment in the study. The
      exclusion criteria included: (a) any acute coronary syndrome within 3 months; (b) severe
      heart failure issues; (c)severe renal failure (d) failure to provide written informed
      consent.The radial access group consisted of patients with single or bi-radial approach. Any
      femoral artery puncture was considered a femoral case. For example, a crossover from any
      radial to femoral access was considered a femoral case. Procedures were performed by 4
      interventional cardiologists, who are dedicated radial operators, at 4 different centers. The
      protocol was approved by the institutional review board and all patients provided written
      informed consent.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Procedural success
time frame: 24 hours
description: Technical success without any in-hospital event
measure: Major access site complications
time frame: 24 hours
description: Major bleeding, vascular complication requiring intervention and hematomas ≥ 10 cm
arm group label: Transradial approach
arm group type: Active Comparator
description: target vessel revascularization via radial access site is labeled as transradial approach
arm group label: Transfemoral approach
arm group type: Active Comparator
description: target vessel revascularization via femoral access site is labeled as transfemoral approach
intervention type: Other
intervention name: radial access site
description: radial route
arm group label: Transradial approach
intervention type: Other
intervention name: femoral access site
description: femoral route
arm group label: Transfemoral approach
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sevket Gorgulu, MD
role: Study Chair
affiliation: Acibadem University
facility: 
facility: 
facility: 
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Coronary Occlusion