<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/NCT02255188</url>
  </required_header>
  <id_info>
    <org_study_id>16.01.2014 № 2</org_study_id>
    <nct_id>NCT02255188</nct_id>
  </id_info>
  <brief_title>Experimental Study of the Vascular Prosthesis Manufactured by Electrospinning</brief_title>
  <official_title>Evaluate Hemocompatibility Vascular Prosthesis to Prevent Its Thrombosis</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 purpose of this study is to determine whether the Vascular prosthesis manufactured by&#xD;
      Electrospinning is safe with respect to the development of thrombosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To test the influence of the prostheses to hemostasis blood will be pumped through the&#xD;
      vascular prosthesis or control silicone tube (both with identical inner diameter 1,7 mm)&#xD;
      during 20 minutes at a linear velocity 10 cm/sec (corresponding to 18 ml/min). The tested&#xD;
      prostheses (or control tubes) will be installed between two syringes with blood installed in&#xD;
      the UTPS-1 instrument providing synchronical movement of pistons of both syringes. Installing&#xD;
      UTPS-1 was designed and manufactured at the Institute of Chemical Biology and Fundamental&#xD;
      Medicine, Siberian Branch of the Russian Academy of Sciences consists of a mechanical&#xD;
      pushers, equipped with clamps for syringes and pistons, stepper motor, electronic control&#xD;
      unit and power supply.&#xD;
&#xD;
      UTPS-1 and polypropylene non-pyrogenic syringes filled with blood without any bulbs of air&#xD;
      provides absence of contacts with air, pyrogens and minimize lysis of blood cells. UTPS-1 has&#xD;
      no analogues, and does not require licensure, metrological control or obtaining of any other&#xD;
      permits.&#xD;
&#xD;
      After pumping the blood will be separated into plasma and cell fraction according to standard&#xD;
      laboratory methods. Primary blood (before any treatment), blood after pumping through silicon&#xD;
      tube (control), and vascular prosthesis will be tested for hemostatic parameters.&#xD;
&#xD;
      Notification of basic and additional parameters being studied, which will be&#xD;
&#xD;
      evaluated in the study:&#xD;
&#xD;
        1. The initial parameters of blood hemostasis will be evaluated (Platelet count; Platelet&#xD;
           aggregation; Prothrombin time, International Normalised Ratio [INR], activated partial&#xD;
           thromboplastin time (aPTT), prothrombin Quick, thrombin time, soluble fibrin monomer&#xD;
           complexes (SFMC), free hemoglobin and P- selectin concentrations).&#xD;
&#xD;
        2. To evaluate the influence of the prosthesis to circulating blood the same hemostasis&#xD;
           characteristics wiil be evaluated in blood after 20 min of circulation through&#xD;
           prosthesis and silicon tube (Platelet count; Platelet aggregation; Prothrombin time,&#xD;
           International Normalised Ratio [INR], activated partial thromboplastin time (aPTT),&#xD;
           prothrombin Quick, thrombin time, soluble fibrin monomer complexes (SFMC), the&#xD;
           measurement of free hemoglobin, P- selectin).&#xD;
&#xD;
        3. Microscopy: a study of adhesion of blood cells on the surface of the prosthesis&#xD;
&#xD;
      Description of Design of the Research: this will be prospective (are marked in section&#xD;
      Detailed Description)&#xD;
&#xD;
      Monocentred research&#xD;
&#xD;
      Defined indicators for each prosthesis&#xD;
&#xD;
      1. hemostasis characteristics listed hereinabove for untreated blood (control)&#xD;
&#xD;
      2 hemostasis characteristics listed hereinabove in blood after 20 min circulation through&#xD;
      silicone tube (control)&#xD;
&#xD;
      3 hemostasis characteristics listed hereinabove in blood after 20 min circulation through&#xD;
      After the interaction with the experimental vascular prosthesis&#xD;
&#xD;
      Will be studied 4 types of vascular prostheses made by electrospinning&#xD;
&#xD;
        -  polycaprolactone;&#xD;
&#xD;
        -  polycaprolactone / gelatin/poorly permeable layer;&#xD;
&#xD;
        -  polylactide-co-glycolide / polycaprolactone / gelatin/poorly permeable layer;&#xD;
&#xD;
        -  nylon 6&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Number of participants (blood samples) having a higher degree of aggregation of platelets after interaction with the prosthesis, as a sign of thrombosis. (with ristomycin, adrenaline, collagen, ADP)</measure>
    <time_frame>during the day</time_frame>
    <description>percentage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Platelet count</measure>
    <time_frame>during the day</time_frame>
    <description>cells / L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prothrombin time</measure>
    <time_frame>during the day</time_frame>
    <description>seconds</description>
  </secondary_outcome>
  <other_outcome>
    <measure>International Normalised Ratio</measure>
    <time_frame>during the day</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>activated partial thromboplastin time</measure>
    <time_frame>during the day</time_frame>
    <description>seconds</description>
  </other_outcome>
  <other_outcome>
    <measure>prothrombin Quick</measure>
    <time_frame>during the day</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>thrombin time</measure>
    <time_frame>during the day</time_frame>
    <description>seconds</description>
  </other_outcome>
  <other_outcome>
    <measure>soluble fibrin monomer complexes</measure>
    <time_frame>during the day</time_frame>
    <description>0-4mg/100ml</description>
  </other_outcome>
  <other_outcome>
    <measure>free hemoglobin</measure>
    <time_frame>during the day</time_frame>
    <description>g / l</description>
  </other_outcome>
  <other_outcome>
    <measure>P- selectin concentrations</measure>
    <time_frame>during the day</time_frame>
    <description>ng / ml</description>
  </other_outcome>
  <other_outcome>
    <measure>Adhesion of blood cells on the surface of the prosthesis</measure>
    <time_frame>during the day</time_frame>
    <description>microscopy</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>ARTERIAL OCCLUSIVE DISEASE</condition>
  <arm_group>
    <arm_group_label>Graft type - PCL</arm_group_label>
    <description>PCL - polycaprolactone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Graft type - PCL/ gelatin</arm_group_label>
    <description>polycaprolactone/ gelatin/poorly permeable layer;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Graft type - PLGA/PCL/gelatin</arm_group_label>
    <description>PLGA/PCL/gelatin - polylactide-co-glycolide / polycaprolactone / gelatin/poorly permeable layer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Graft type - nylon 6</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>blood sampling procedure</intervention_name>
    <description>30 ml of venous blood will be collected from all voluteers using a special vacuum tubes after informed consent. Blood sampling is carried out from an arm vein. All subsequent studies will be executed in the laboratory diagnostic division of Novosibirsk Research Institute of Circulation Pathology and the presence of the donors is unnecessary</description>
    <arm_group_label>Graft type - PCL</arm_group_label>
    <arm_group_label>Graft type - PCL/ gelatin</arm_group_label>
    <arm_group_label>Graft type - PLGA/PCL/gelatin</arm_group_label>
    <arm_group_label>Graft type - nylon 6</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        volunteers, donors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged from 18 to 50 years at the date of the informed consent signing;&#xD;
&#xD;
          -  Patients without atherosclerosis&#xD;
&#xD;
          -  Patients without blood pathology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient did not sign the informed consent.&#xD;
&#xD;
          -  Early postoperative period.&#xD;
&#xD;
          -  Concomitant diseases such as atherosclerosis, blood pathology, venous thrombosis,&#xD;
             malignancy, terminal cancer, infectious - inflammatory disease at the time of the&#xD;
             study.&#xD;
&#xD;
          -  Patients after implantation of a cardioverter-defibrillator; prior prosthetic heart&#xD;
             valves or other implants, which can lead to mechanical damage to the blood cells.&#xD;
&#xD;
          -  Receiving anticoagulants, antiplatelet, antibacterial drugs, NSAIDs.&#xD;
&#xD;
          -  Myocardial infarction less than 3 months ago.&#xD;
&#xD;
          -  Irreversible failure of major organs with an expected survival time of less than 1&#xD;
             year&#xD;
&#xD;
          -  Pregnancy, lactation.&#xD;
&#xD;
          -  Age above 50 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>popova Irina</name>
      <address>
        <city>Novosibirsk</city>
        <state>Novosibirskay obl.</state>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Haemostas, prosthesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arterial Occlusive Diseases</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/NCT02255188
org study id: 16.01.2014 № 2
nct id: NCT02255188
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether the Vascular prosthesis manufactured by
      Electrospinning is safe with respect to the development of thrombosis.
To test the influence of the prostheses to hemostasis blood will be pumped through the
      vascular prosthesis or control silicone tube (both with identical inner diameter 1,7 mm)
      during 20 minutes at a linear velocity 10 cm/sec (corresponding to 18 ml/min). The tested
      prostheses (or control tubes) will be installed between two syringes with blood installed in
      the UTPS-1 instrument providing synchronical movement of pistons of both syringes. Installing
      UTPS-1 was designed and manufactured at the Institute of Chemical Biology and Fundamental
      Medicine, Siberian Branch of the Russian Academy of Sciences consists of a mechanical
      pushers, equipped with clamps for syringes and pistons, stepper motor, electronic control
      unit and power supply.

      UTPS-1 and polypropylene non-pyrogenic syringes filled with blood without any bulbs of air
      provides absence of contacts with air, pyrogens and minimize lysis of blood cells. UTPS-1 has
      no analogues, and does not require licensure, metrological control or obtaining of any other
      permits.

      After pumping the blood will be separated into plasma and cell fraction according to standard
      laboratory methods. Primary blood (before any treatment), blood after pumping through silicon
      tube (control), and vascular prosthesis will be tested for hemostatic parameters.

      Notification of basic and additional parameters being studied, which will be

      evaluated in the study:

        1. The initial parameters of blood hemostasis will be evaluated (Platelet count; Platelet
           aggregation; Prothrombin time, International Normalised Ratio [INR], activated partial
           thromboplastin time (aPTT), prothrombin Quick, thrombin time, soluble fibrin monomer
           complexes (SFMC), free hemoglobin and P- selectin concentrations).

        2. To evaluate the influence of the prosthesis to circulating blood the same hemostasis
           characteristics wiil be evaluated in blood after 20 min of circulation through
           prosthesis and silicon tube (Platelet count; Platelet aggregation; Prothrombin time,
           International Normalised Ratio [INR], activated partial thromboplastin time (aPTT),
           prothrombin Quick, thrombin time, soluble fibrin monomer complexes (SFMC), the
           measurement of free hemoglobin, P- selectin).

        3. Microscopy: a study of adhesion of blood cells on the surface of the prosthesis

      Description of Design of the Research: this will be prospective (are marked in section
      Detailed Description)

      Monocentred research

      Defined indicators for each prosthesis

      1. hemostasis characteristics listed hereinabove for untreated blood (control)

      2 hemostasis characteristics listed hereinabove in blood after 20 min circulation through
      silicone tube (control)

      3 hemostasis characteristics listed hereinabove in blood after 20 min circulation through
      After the interaction with the experimental vascular prosthesis

      Will be studied 4 types of vascular prostheses made by electrospinning

        -  polycaprolactone;

        -  polycaprolactone / gelatin/poorly permeable layer;

        -  polylactide-co-glycolide / polycaprolactone / gelatin/poorly permeable layer;

        -  nylon 6
observational model: Cohort
time perspective: Prospective
measure: Number of participants (blood samples) having a higher degree of aggregation of platelets after interaction with the prosthesis, as a sign of thrombosis. (with ristomycin, adrenaline, collagen, ADP)
time frame: during the day
description: percentage
measure: Platelet count
time frame: during the day
description: cells / L
measure: Prothrombin time
time frame: during the day
description: seconds
measure: International Normalised Ratio
time frame: during the day
measure: activated partial thromboplastin time
time frame: during the day
description: seconds
measure: prothrombin Quick
time frame: during the day
measure: thrombin time
time frame: during the day
description: seconds
measure: soluble fibrin monomer complexes
time frame: during the day
description: 0-4mg/100ml
measure: free hemoglobin
time frame: during the day
description: g / l
measure: P- selectin concentrations
time frame: during the day
description: ng / ml
measure: Adhesion of blood cells on the surface of the prosthesis
time frame: during the day
description: microscopy
arm group label: Graft type - PCL
description: PCL - polycaprolactone
arm group label: Graft type - PCL/ gelatin
description: polycaprolactone/ gelatin/poorly permeable layer;
arm group label: Graft type - PLGA/PCL/gelatin
description: PLGA/PCL/gelatin - polylactide-co-glycolide / polycaprolactone / gelatin/poorly permeable layer
arm group label: Graft type - nylon 6
intervention type: Procedure
intervention name: blood sampling procedure
description: 30 ml of venous blood will be collected from all voluteers using a special vacuum tubes after informed consent. Blood sampling is carried out from an arm vein. All subsequent studies will be executed in the laboratory diagnostic division of Novosibirsk Research Institute of Circulation Pathology and the presence of the donors is unnecessary
arm group label: Graft type - PCL
arm group label: Graft type - PCL/ gelatin
arm group label: Graft type - PLGA/PCL/gelatin
arm group label: Graft type - nylon 6
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Arterial Occlusive Diseases