<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/NCT02209350</url>
  </required_header>
  <id_info>
    <org_study_id>TASC C,D</org_study_id>
    <nct_id>NCT02209350</nct_id>
  </id_info>
  <brief_title>Study of the AFB and Stenting of the Iliac Arteries</brief_title>
  <official_title>Prospective Randomized Clinical Study of the Aorto-femoral Bypass and the Iliac Arteries With Stenting Recanalization Effectiveness in Patients With the Iliac Segment Occlusive Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meshalkin Research Institute of Pathology of Circulation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meshalkin Research Institute of Pathology of Circulation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to compare effectiveness and long-term results of aorta-femoral&#xD;
      reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC&#xD;
      C,D).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 2, 2014</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Phase 1</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>The primary composite endpoint (efficacy): primary patency, secondary patency</measure>
    <time_frame>30 days</time_frame>
    <description>If a damage confirmed by duplex is detected, repeat intervention is performed on the side of the examined segment. The physiological parameter and questionnaire will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>success of the procedure</measure>
    <time_frame>30 days</time_frame>
    <description>Technical ability to perform the surgical intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>safeness: clinically significant bleeding, hematoma, infection of the prosthesis, infection of postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment, distal embolism</measure>
    <time_frame>30 days</time_frame>
    <description>Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire. Classification of bleeding will be used GUSTO (Severe or moderate)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality in the long-term postoperative period</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke in the remote postoperative period</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction in the remote postoperative period</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>preservation of limb in the long-term postoperative period</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Aorta-iliac Segment Lesion (C,D Type by TASC II)</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Operations technique on the abdominal aorta. Aorta-femoral bypass. Medication: after surgery all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard endovascular treatment (stenting) in patients with the iliac segment occlusive disease. Medication: after stenting all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Aorta-femoral bypass</intervention_name>
    <description>Access to the femoral artery is performed through a lateral incision from the inguinal ligament. Operations technique on the abdominal aorta.&#xD;
Aorta-femoral bypass. Proximal anastomosis between the prosthesis and aorta is applied in the sort of &quot;end-to-side&quot; in the reconstruction by shunting.&#xD;
After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. In a case of preserved antegrade blood flow the femoral artery anastomosis applied in the sort of &quot;end-to-side&quot;. If antegrade flow is absent, anastomosis is formed in the sort of &quot;end to end&quot;.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Recanalization and stenting of aorta-iliac segment</intervention_name>
    <description>Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized.&#xD;
Stenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often &quot;mixed&quot;) artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter).</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Therapy: aspirin and clopidogrel</intervention_name>
    <description>prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with occlusive lesions of C and D type iliac segment, and with chronic lower&#xD;
             limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford), age: 47-75 years&#xD;
             old.&#xD;
&#xD;
          -  Patients who consented to participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic heart failure of III-IV functional class by NYHA classification.&#xD;
&#xD;
          -  Decompensated chronic &quot;pulmonary&quot; heart&#xD;
&#xD;
          -  Severe hepatic or renal failure (bilirubin&gt; 35 mmol / l, glomerular filtration rate&#xD;
             &lt;60 mL / min);&#xD;
&#xD;
          -  Polyvalent drug allergy&#xD;
&#xD;
          -  Cancer in the terminal stage with a life expectancy less than 6 months;&#xD;
&#xD;
          -  Acute ischemic&#xD;
&#xD;
          -  Expressed aortic calcification tolerant to angioplasty&#xD;
&#xD;
          -  Patients with significant common femoral artery lesion&#xD;
&#xD;
          -  Patient refusal to participate or continue to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrey Karpenko, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Novosibirsk Research Institute of Circulation Pathology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novosibirsk Research Institute of Circulation Pathology</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Clopidogrel</mesh_term>
  </intervention_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/NCT02209350
org study id: TASC C,D
nct id: NCT02209350
lead sponsor: 
has dmc: Yes
The aim of the study is to compare effectiveness and long-term results of aorta-femoral
      reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC
      C,D).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary composite endpoint (efficacy): primary patency, secondary patency
time frame: 30 days
description: If a damage confirmed by duplex is detected, repeat intervention is performed on the side of the examined segment. The physiological parameter and questionnaire will be used.
measure: success of the procedure
time frame: 30 days
description: Technical ability to perform the surgical intervention
measure: safeness: clinically significant bleeding, hematoma, infection of the prosthesis, infection of postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment, distal embolism
time frame: 30 days
description: Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire. Classification of bleeding will be used GUSTO (Severe or moderate)
measure: mortality in the long-term postoperative period
time frame: 3 years
measure: stroke in the remote postoperative period
time frame: 3 years
measure: myocardial infarction in the remote postoperative period
time frame: 3 years
measure: preservation of limb in the long-term postoperative period
time frame: 3 years
arm group label: Group 1
arm group type: Active Comparator
description: Operations technique on the abdominal aorta. Aorta-femoral bypass. Medication: after surgery all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).
arm group label: Group 2
arm group type: Active Comparator
description: Standard endovascular treatment (stenting) in patients with the iliac segment occlusive disease. Medication: after stenting all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).
intervention type: Procedure
intervention name: Aorta-femoral bypass
description: Access to the femoral artery is performed through a lateral incision from the inguinal ligament. Operations technique on the abdominal aorta.
Aorta-femoral bypass. Proximal anastomosis between the prosthesis and aorta is applied in the sort of "end-to-side" in the reconstruction by shunting.
After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. In a case of preserved antegrade blood flow the femoral artery anastomosis applied in the sort of "end-to-side". If antegrade flow is absent, anastomosis is formed in the sort of "end to end".
arm group label: Group 1
intervention type: Procedure
intervention name: Recanalization and stenting of aorta-iliac segment
description: Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized.
Stenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often "mixed") artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter).
arm group label: Group 2
intervention type: Drug
intervention name: Therapy: aspirin and clopidogrel
description: prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Andrey Karpenko, MD, PhD
role: Principal Investigator
affiliation: Novosibirsk Research Institute of Circulation Pathology
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Aspirin
mesh term: Clopidogrel