<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/NCT04461496</url>
  </required_header>
  <id_info>
    <org_study_id>FMJ</org_study_id>
    <nct_id>NCT04461496</nct_id>
  </id_info>
  <brief_title>Full Metall Jacket Multilevel Segment</brief_title>
  <acronym>FMJSFA</acronym>
  <official_title>The Pilot Clinical Trial Comparing the Efficacy of Single-stage Multilevel Revascularization of the Iliac-femoral-popliteal Segment Using the FULL METALL JACKET Technology in Comparison With the Hybrid Revascularization Procedure</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis: &quot;Total&quot; endovascular revascularization of a multistory lesion of the&#xD;
      iliac-femoral-popliteal segment is safer and a better quality of life is achieved in&#xD;
      comparison with hybrid intervention.&#xD;
&#xD;
      The lack of damage to the skin avoids complications in the postoperative and remote periods&#xD;
      of observation, thereby improving the quality of life&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mortality from cardiovascular disease occupies a leading position worldwide. Patients with&#xD;
      atherosclerotic lesions of the peripheral arteries account for 20% of the total number of&#xD;
      patients with cardiovascular diseases. Special attention should be paid to patients with&#xD;
      multilevel lesions artery since the maximum reduction in blood flow leads to the development&#xD;
      of critical limb ischemia (CLI) and a high risk of limb loss. Almost 25% of patients with CLI&#xD;
      require multistory revascularization of the arteries of the lower extremities. In this group&#xD;
      of patients, proximal revascularization of the only iliac segment is usually the initial&#xD;
      approach, but in some cases leads to disappointing relief of symptoms due to concomitant&#xD;
      severe lesions of the infra-anginal arteries. Whereas the combined implementation of&#xD;
      femoral-popliteal bypass surgery or endovascular revascularization of SFA can increase the&#xD;
      likelihood of ulcer healing and avoid multi-stage surgical interventions. In turn, an&#xD;
      adequate inflow to the revascularized segment is necessary for its long-term functioning.&#xD;
&#xD;
      Femoral-popliteal bypass surgery is still the procedure of choice for long occlusions of the&#xD;
      superficial femoral artery TASC C, D. The &quot;total&quot; endovascular correction (full metal jacket)&#xD;
      may become an alternative to hybrid technology since allows for less traumatic and fully&#xD;
      revascularization of the wall occlusal lesions of SFA. The salvation of the limb and the&#xD;
      achievement of compensation for the clinic of chronic lower limb ischemia in patients with&#xD;
      multi-vessel atherosclerotic lesions of the arteries of the lower extremities is possible&#xD;
      using both hybrid procedures and endovascular reconstruction. The main goal of stenting the&#xD;
      iliac arteries during hybrid procedures is not only to restore blood flow in the common and&#xD;
      deep femoral arteries but also to support the long-term functioning of the femoral-popliteal&#xD;
      shunt or stent in SFA.&#xD;
&#xD;
      Similar analogues of the comparative study of the two methods of revascularization in the&#xD;
      world literature the investigators have not seen.&#xD;
&#xD;
      In the first group, stenting of the iliac artery under x-ray control with the bypass of the&#xD;
      femoral-popliteal segment above the gap of the knee joint is performed. The first stage is&#xD;
      performed femoral-popliteal bypass surgery above the fissure of the knee joint according to&#xD;
      conventional technology. Conduit is at the discretion of the operating surgeon.&#xD;
      Intraoperatively bolus is administered heparin 5000 IU. The second step is the puncture of&#xD;
      the selected CFA with a retrograde installation of the introducer sheath. The iliac segment&#xD;
      is recanalized with angioplasty and stent implantation in the affected area. In the&#xD;
      postoperative period, clexane is administered at a prophylactic dosage of 3 days and&#xD;
      cardiomagnyl at a dosage of 75 mg per day. Next, the patient takes dual antiplatelet therapy&#xD;
      cardiomagnyl 75 mg + clopidogrel 75 mg for 6 months.&#xD;
&#xD;
      In the second group, stenting of the iliac artery and recanalization SFA with angioplasty and&#xD;
      stenting under X-ray control is performed. The first step is the puncture contralateral CFA&#xD;
      with a retrograde installation of the introducer. Intraoperatively bolus is administered&#xD;
      heparin 5000 IU. A conductor is placed in the contralateral iliac artery along the conductor.&#xD;
      A stent is implanted in the iliac artery lesion. The second stage is the recanalization of&#xD;
      the femoral-popliteal segment with angioplasty and stent implantation in the affected area.&#xD;
      In the postoperative period, a loading dose of clopidogrel 300 mg + cardiomagnyl 75 mg is&#xD;
      taken. Next, the patient takes dual antiplatelet therapy cardiomagnyl 75 mg + clopidogrel 75&#xD;
      mg for 6 months.&#xD;
&#xD;
      Statistical analysis: Data processing and comparison of variables will be carried out by&#xD;
      appropriate statistical methods with a preliminary check for compliance of the sign&#xD;
      variability with the normal distribution, which is evaluated by the Kolmogorov-Smirnov&#xD;
      criterion. Under the condition of the normal distribution, Student's criterion is used. A&#xD;
      comparative assessment of qualitative characteristics is carried out using the χ2 criterion.&#xD;
      The dynamics of the indicators in the group will be determined by the pairwise coupled option&#xD;
      using the Student criterion with a normal distribution of indicators and using the Wilcoxon&#xD;
      criterion - with a mismatch with the normal distribution. Comparison according to qualitative&#xD;
      characteristics (gender, degree of ischemia, and others) will be carried out using the&#xD;
      criteria of Pearson (Pearson) and Fisher (Fisher). In all cases, a 95% significance level is&#xD;
      used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">June 5, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 5, 2025</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>Efficacy of the procedure</measure>
    <time_frame>24 months</time_frame>
    <description>freedom from thrombosis was defined as the absence of occlusion by duplex ultrasonography or CT angiography of the treated segment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety of the procedure</measure>
    <time_frame>30 days</time_frame>
    <description>bleeding according to blood loss volume (millilitres) 1. intraoperative blood loss volume; 2.Postoperative blood loss volume by duplex ultrasonography and drainage losses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety of the procedure</measure>
    <time_frame>24 months</time_frame>
    <description>major adverse limb events according to clinical evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary patency</measure>
    <time_frame>24 months</time_frame>
    <description>Primary patency rate at 24 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary patency</measure>
    <time_frame>24 months</time_frame>
    <description>Secondary patency rate at 24 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the patients quality of life: questionnaire</measure>
    <time_frame>24 months</time_frame>
    <description>improving the quality of life in accordance with the questionnaire &quot;The Short Form-36&quot; for 24 months. The indicators of each scale are designed in such a way that the higher the value of the indicator (from 0 to 100), the better the score on the selected scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success of the procedure</measure>
    <time_frame>1 month</time_frame>
    <description>the number of successful attempts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in chronic lower limb ischemia at 24 months follow-up</measure>
    <time_frame>24 months</time_frame>
    <description>Number of cases of improvement of at least 1 category of Rutherford classification for claudicants</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Superficial Femoral Artery Stenosis</condition>
  <condition>Iliac Artery Occlusion</condition>
  <arm_group>
    <arm_group_label>Hybrid revascularization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 hybrid procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full metall jacket</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 total endovascular interventions</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hybrid revascularization</intervention_name>
    <description>The first stage is performed femoral-popliteal bypass surgery above the fissure of the knee joint according to conventional technology. Conduit is at the discretion of the operating surgeon. Intraoperatively bolus is administered sol. heparin 5000 IU. The second step is the puncture of the selected CFA with a retrograde installation of the introducer sheath. The iliac segment is recanalized with angioplasty and stent implantation in the affected area</description>
    <arm_group_label>Hybrid revascularization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Full metall Jacket</intervention_name>
    <description>The first step is the puncture contralateral CFA with a retrograde installation of the introducer. Intraoperatively bolus is administered sol. heparin 5000 IU. A conductor is placed in the contralateral iliac artery along the conductor. A stent is implanted in the iliac artery lesion. The second stage is the recanalization of the femoral-popliteal segment with angioplasty and stent implantation in the affected area.</description>
    <arm_group_label>Full metall jacket</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with multisegment lesions of the iliac-femoral-popliteal segment, with the&#xD;
             distal border of the lesion above the slit of the knee joint.&#xD;
&#xD;
          -  chronic ischemia 3-6 (according to Rutherford),&#xD;
&#xD;
          -  the satisfactory direction of the outflow.&#xD;
&#xD;
          -  Patients who gave consent to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic occlusion of the SFA at least 2cm&#xD;
&#xD;
          -  Heavy calcification of SFA • Infection in the area of the access artery&#xD;
&#xD;
          -  Expressed, more than 50% stenotic lesions of the infrarenal aorta&#xD;
&#xD;
          -  Prolonged loss (TASC D) iliac artery on the side of revascularization&#xD;
&#xD;
          -  aneurysmal widening of the infrarenal aorta and iliac arteries&#xD;
&#xD;
          -  Hemodynamically significant lesions DFA&#xD;
&#xD;
          -  Chronic heart failure III-IV functional class NYHA classification;&#xD;
&#xD;
          -  decompensated Chronic &quot;pulmonary&quot; heart; • Severe hepatic or renal insufficiency&#xD;
             (bilirubin &gt;35 mmol/l, glomerular filtration rate &lt;60 ml/min);&#xD;
&#xD;
          -  Polyvalent drug Allergy;&#xD;
&#xD;
          -  Malignant cancer in the terminal stage with a projected life span of 6 months;&#xD;
&#xD;
          -  Acute stroke;&#xD;
&#xD;
          -  a Pronounced calcification of the arteries of the lower limbs;&#xD;
&#xD;
          -  Patients with significant lesions of the common femoral artery&#xD;
&#xD;
          -  the Refusal of a patient 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_contact>
    <last_name>Andrey A Karpenko, PHD</last_name>
    <phone>89139504100</phone>
    <email>a_karpenko@meshalkin.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meshalkin Research Institute of Pathology of Circulation</name>
      <address>
        <city>Novosibirsk</city>
        <state>Novosibirskaya Obl</state>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrey A Karpenko, PHD</last_name>
      <phone>89134504100</phone>
      <email>a_karpenko@meshalkin.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hybrid revascularization</keyword>
  <keyword>atherosclerosis</keyword>
  <!-- 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/NCT04461496
org study id: FMJ
nct id: NCT04461496
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hypothesis: "Total" endovascular revascularization of a multistory lesion of the
      iliac-femoral-popliteal segment is safer and a better quality of life is achieved in
      comparison with hybrid intervention.

      The lack of damage to the skin avoids complications in the postoperative and remote periods
      of observation, thereby improving the quality of life
Mortality from cardiovascular disease occupies a leading position worldwide. Patients with
      atherosclerotic lesions of the peripheral arteries account for 20% of the total number of
      patients with cardiovascular diseases. Special attention should be paid to patients with
      multilevel lesions artery since the maximum reduction in blood flow leads to the development
      of critical limb ischemia (CLI) and a high risk of limb loss. Almost 25% of patients with CLI
      require multistory revascularization of the arteries of the lower extremities. In this group
      of patients, proximal revascularization of the only iliac segment is usually the initial
      approach, but in some cases leads to disappointing relief of symptoms due to concomitant
      severe lesions of the infra-anginal arteries. Whereas the combined implementation of
      femoral-popliteal bypass surgery or endovascular revascularization of SFA can increase the
      likelihood of ulcer healing and avoid multi-stage surgical interventions. In turn, an
      adequate inflow to the revascularized segment is necessary for its long-term functioning.

      Femoral-popliteal bypass surgery is still the procedure of choice for long occlusions of the
      superficial femoral artery TASC C, D. The "total" endovascular correction (full metal jacket)
      may become an alternative to hybrid technology since allows for less traumatic and fully
      revascularization of the wall occlusal lesions of SFA. The salvation of the limb and the
      achievement of compensation for the clinic of chronic lower limb ischemia in patients with
      multi-vessel atherosclerotic lesions of the arteries of the lower extremities is possible
      using both hybrid procedures and endovascular reconstruction. The main goal of stenting the
      iliac arteries during hybrid procedures is not only to restore blood flow in the common and
      deep femoral arteries but also to support the long-term functioning of the femoral-popliteal
      shunt or stent in SFA.

      Similar analogues of the comparative study of the two methods of revascularization in the
      world literature the investigators have not seen.

      In the first group, stenting of the iliac artery under x-ray control with the bypass of the
      femoral-popliteal segment above the gap of the knee joint is performed. The first stage is
      performed femoral-popliteal bypass surgery above the fissure of the knee joint according to
      conventional technology. Conduit is at the discretion of the operating surgeon.
      Intraoperatively bolus is administered heparin 5000 IU. The second step is the puncture of
      the selected CFA with a retrograde installation of the introducer sheath. The iliac segment
      is recanalized with angioplasty and stent implantation in the affected area. In the
      postoperative period, clexane is administered at a prophylactic dosage of 3 days and
      cardiomagnyl at a dosage of 75 mg per day. Next, the patient takes dual antiplatelet therapy
      cardiomagnyl 75 mg + clopidogrel 75 mg for 6 months.

      In the second group, stenting of the iliac artery and recanalization SFA with angioplasty and
      stenting under X-ray control is performed. The first step is the puncture contralateral CFA
      with a retrograde installation of the introducer. Intraoperatively bolus is administered
      heparin 5000 IU. A conductor is placed in the contralateral iliac artery along the conductor.
      A stent is implanted in the iliac artery lesion. The second stage is the recanalization of
      the femoral-popliteal segment with angioplasty and stent implantation in the affected area.
      In the postoperative period, a loading dose of clopidogrel 300 mg + cardiomagnyl 75 mg is
      taken. Next, the patient takes dual antiplatelet therapy cardiomagnyl 75 mg + clopidogrel 75
      mg for 6 months.

      Statistical analysis: Data processing and comparison of variables will be carried out by
      appropriate statistical methods with a preliminary check for compliance of the sign
      variability with the normal distribution, which is evaluated by the Kolmogorov-Smirnov
      criterion. Under the condition of the normal distribution, Student's criterion is used. A
      comparative assessment of qualitative characteristics is carried out using the χ2 criterion.
      The dynamics of the indicators in the group will be determined by the pairwise coupled option
      using the Student criterion with a normal distribution of indicators and using the Wilcoxon
      criterion - with a mismatch with the normal distribution. Comparison according to qualitative
      characteristics (gender, degree of ischemia, and others) will be carried out using the
      criteria of Pearson (Pearson) and Fisher (Fisher). In all cases, a 95% significance level is
      used.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of the procedure
time frame: 24 months
description: freedom from thrombosis was defined as the absence of occlusion by duplex ultrasonography or CT angiography of the treated segment
measure: Safety of the procedure
time frame: 30 days
description: bleeding according to blood loss volume (millilitres) 1. intraoperative blood loss volume; 2.Postoperative blood loss volume by duplex ultrasonography and drainage losses
measure: Safety of the procedure
time frame: 24 months
description: major adverse limb events according to clinical evaluation
measure: Primary patency
time frame: 24 months
description: Primary patency rate at 24 months follow-up
measure: Secondary patency
time frame: 24 months
description: Secondary patency rate at 24 months follow-up
measure: Changes in the patients quality of life: questionnaire
time frame: 24 months
description: improving the quality of life in accordance with the questionnaire "The Short Form-36" for 24 months. The indicators of each scale are designed in such a way that the higher the value of the indicator (from 0 to 100), the better the score on the selected scale
measure: Success of the procedure
time frame: 1 month
description: the number of successful attempts
measure: Changes in chronic lower limb ischemia at 24 months follow-up
time frame: 24 months
description: Number of cases of improvement of at least 1 category of Rutherford classification for claudicants
arm group label: Hybrid revascularization
arm group type: Active Comparator
description: 50 hybrid procedure
arm group label: Full metall jacket
arm group type: Experimental
description: 50 total endovascular interventions
intervention type: Procedure
intervention name: Hybrid revascularization
description: The first stage is performed femoral-popliteal bypass surgery above the fissure of the knee joint according to conventional technology. Conduit is at the discretion of the operating surgeon. Intraoperatively bolus is administered sol. heparin 5000 IU. The second step is the puncture of the selected CFA with a retrograde installation of the introducer sheath. The iliac segment is recanalized with angioplasty and stent implantation in the affected area
arm group label: Hybrid revascularization
intervention type: Procedure
intervention name: Full metall Jacket
description: The first step is the puncture contralateral CFA with a retrograde installation of the introducer. Intraoperatively bolus is administered sol. heparin 5000 IU. A conductor is placed in the contralateral iliac artery along the conductor. A stent is implanted in the iliac artery lesion. The second stage is the recanalization of the femoral-popliteal segment with angioplasty and stent implantation in the affected area.
arm group label: Full metall jacket
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Andrey A Karpenko, PHD
phone: 89139504100
email: a_karpenko@meshalkin.ru
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Sponsor