xml: <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/NCT06034691</url>
    </required_header>
    <id_info>
      <org_study_id>LY2023-113-A</org_study_id>
      <nct_id>NCT06034691</nct_id>
    </id_info>
    <brief_title>Exploratory Research of PCSK9 Inhibitor on Patency of aAVF After PTA With PCB</brief_title>
    <official_title>Exploratory Research of PCSK9 Inhibitor on Patency of Autogenous Arteriovenous Fistula After Percutaneous Transluminal Angioplasty With Paclitaxel Releasing Balloon</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Autologous arteriovenous fistula (AVF) is the preferred vascular pathway type for maintenance&#xD;
        hemodialysis (MHD) patients. The K/DOQI guidelines suggest that the use of percutaneous&#xD;
        transluminal angioplasty (PTA) as the primary treatment for AVF stenosis is reasonable.&#xD;
        However, the durability of PTA is limited. In order to reduce the risk of dysfunction&#xD;
        recurrence after the intervention, there have been reports in recent years that drug-coated&#xD;
        balloons (DCB) are used in the treatment of vascular stenosis in hemodialysis. Multiple&#xD;
        factors have limited the efficacy of DCB. Previous studies on the related factors of&#xD;
        hemodialysis access stenosis showed that Dyslipidemia was significantly related to the short&#xD;
        initial patency rate, and Dyslipidemia was an important predictor of secondary patency loss.&#xD;
        Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a new type of&#xD;
        lipid-lowering drug that can prevent vascular calcification. Previous studies have shown that&#xD;
        PCSK9 inhibitors have good lipid-lowering effects in both MHD patients and nondialysis&#xD;
        patients, and the use of PSK9 inhibitors at the same dose as nondialysis patients is safe in&#xD;
        MHD patients. There are currently few studies on the use of paclitaxel-releasing balloon&#xD;
        dilation combined with PCSK9 inhibitors to improve autologous internal fistula. Therefore,&#xD;
        the investigators applied a prospective, randomized, and controlled study method to&#xD;
        preliminarily explore the effect of paclitaxel releasing balloon combined with PCSK9&#xD;
        inhibitor on improving the postoperative patency rate of AVF and the safety of the combined&#xD;
        application.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 6, 2024</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Value of vessel diameter</measure>
      <time_frame>24 week, 48 week</time_frame>
      <description>ultrasonic measurement</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Value of volume of blood flow</measure>
      <time_frame>24 week, 48 week</time_frame>
      <description>ultrasonic measurement</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Value of peak systolic velocity ratio（PSVR）</measure>
      <time_frame>24 week, 48 week</time_frame>
      <description>ultrasonic measurement</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Re intervention of fistula</measure>
      <time_frame>48 week</time_frame>
      <description>Event recording</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Endometrium</measure>
      <time_frame>24 week, 48 week</time_frame>
      <description>Ultrasonic measurement of changes in thickness of vascular intima , expressed in millimeters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>RA</measure>
      <time_frame>24 week, 48 week</time_frame>
      <description>Arteriovenous fistula recirculation rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BTM</measure>
      <time_frame>24 week, 48 week</time_frame>
      <description>Blood temperature monitoring, testing of specific modules of the hemodialysis machine. Expressed as a percentage.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adequacy of dialysis</measure>
      <time_frame>24 week, 48 week</time_frame>
      <description>spKT/V</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood routine</measure>
      <time_frame>12 week, 24 week, 48 week</time_frame>
      <description>Concentration of hemoglobin, white blood cell count, platelet</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>liver function</measure>
      <time_frame>12 week, 24 week, 48 week</time_frame>
      <description>Concentration of GPT, GOT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of blood sugar</measure>
      <time_frame>12 week, 24 week, 48 week</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of CRP</measure>
      <time_frame>12 week, 24 week, 48 week</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>blood lipids</measure>
      <time_frame>12 week, 24 week, 48 week</time_frame>
      <description>Concentration of cholesterol, triglyceride, LDL-c, HDL</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Hemodialysis Access Failure</condition>
    <arm_group>
      <arm_group_label>PCSK9i group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>treatment group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>control group</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>pcsk9 inhibitor</intervention_name>
      <description>The treatment group received postoperative use of 140 mg of Ribavirin, administered every two weeks, with 140 mg administered subcutaneously for a total of 48 weeks. There was no additional intervention with lipid-lowering drugs in the control group.</description>
      <arm_group_label>PCSK9i group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Agree to join this study and sign an informed consent form&#xD;
  &#xD;
            2. Age ≥ 18 years old and ≤ 75 years old, regardless of gender&#xD;
  &#xD;
            3. Maintenance hemodialysis patients using autologous arteriovenous fistula (AVF), with a&#xD;
               dialysis frequency of three times a week&#xD;
  &#xD;
            4. AVF venous stenosis: The local stenosis rate exceeds 50% of the normal diameter of&#xD;
               nearby blood vessels and is accompanied by at least one of the following conditions:&#xD;
  &#xD;
                 1. The natural blood flow of the internal fistula is less than 500ml/min or has&#xD;
                    decreased by more than 25% compared to the previous examination result&#xD;
  &#xD;
                 2. Unable to meet the required blood flow for dialysis prescription (blood&#xD;
                    flow&lt;200ml/min, and cannot be corrected after adjusting the puncture needle&#xD;
                    position)&#xD;
  &#xD;
                 3. Decreased arterial pressure or increased venous pressure during dialysis&#xD;
                    (monitoring arterial pressure&lt;-120mmHg for more than 2 consecutive times or&#xD;
                    monitoring venous pressure&gt;120mmHg while maintaining 200ml/min blood flow)&#xD;
  &#xD;
                 4. Difficulty in puncture: A qualified nurse who has difficulty puncturing for 3&#xD;
                    consecutive days of hemodialysis (blood can only be drawn out after more than two&#xD;
                    punctures)&#xD;
  &#xD;
                 5. Decreased dialysis adequacy [arteriovenous fistula recirculation rate (RA)&gt;10%,&#xD;
                    or an increase of more than 25% compared to the previous examination result]&#xD;
                    [RA=(SA-A)/(SA-V) * 100, dialysis to 1 hour: SA=blood flow adjusted to 20ml/min,&#xD;
                    ultrafiltration and dialysate flow stopped, after 2 minutes, artery Blood urea&#xD;
                    nitrogen concentration A=artery Blood urea nitrogen concentration V=vein Blood&#xD;
                    urea nitrogen concentration]&#xD;
  &#xD;
                 6. Abnormal signs of fistula.&#xD;
  &#xD;
            5. Patients with primary Hypercholesterolemia [LDL-C ≥ 130 mg/dl (≥ 3.4 mmol/L), and/or&#xD;
               non-HDL-C≥ 160 mg/dl (≥ 4.1 mmol/L)] or combine cardiovascular disease or assess&#xD;
               patients with a high risk of cardiovascular disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. MHD with AVG&#xD;
  &#xD;
            2. Breastfeeding or Pregnant Women&#xD;
  &#xD;
            3. Patients with central venous reflux obstruction&#xD;
  &#xD;
            4. Patients with AVF feeding artery disease&#xD;
  &#xD;
            5. Patients with severe Hypotension (systolic blood pressure&lt;90mmHg or diastolic blood&#xD;
               pressure&lt;60mmHg, at least three times within one month before signing the informed&#xD;
               consent)&#xD;
  &#xD;
            6. Left ventricular Ejection fraction less than 30% or hemodynamic instability&#xD;
  &#xD;
            7. Patients receiving immunotherapy or suspected/confirmed Vasculitis&#xD;
  &#xD;
            8. Patients with coagulation dysfunction or a history of Thrombocytopenic purpura&#xD;
  &#xD;
            9. Patients with vascular access infections or systemic active infections&#xD;
  &#xD;
           10. Patients who are known to be allergic to PCSK9 inhibitors or paclitaxel&#xD;
  &#xD;
           11. Patient's life expectancy is less than 12 months&#xD;
  &#xD;
           12. Patients who are planning kidney transplantation or switching to Peritoneal dialysis&#xD;
  &#xD;
           13. Patients participating in other intervention studies&#xD;
  &#xD;
           14. The researcher judged that the subject's condition was not suitable for participation&#xD;
               in this study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>17 Years</minimum_age>
      <maximum_age>76 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Yuanyuan Xie</name>
        <address>
          <city>Shanghai</city>
          <state>Pudong</state>
          <zip>200127</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuanyuan Xie</last_name>
        <phone>+86 13601852981</phone>
        <email>xieyuanyuan@renji.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>PCSK9 Inhibitors</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034691
  org study id: LY2023-113-A
  nct id: NCT06034691
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Autologous arteriovenous fistula (AVF) is the preferred vascular pathway type for maintenance
        hemodialysis (MHD) patients. The K/DOQI guidelines suggest that the use of percutaneous
        transluminal angioplasty (PTA) as the primary treatment for AVF stenosis is reasonable.
        However, the durability of PTA is limited. In order to reduce the risk of dysfunction
        recurrence after the intervention, there have been reports in recent years that drug-coated
        balloons (DCB) are used in the treatment of vascular stenosis in hemodialysis. Multiple
        factors have limited the efficacy of DCB. Previous studies on the related factors of
        hemodialysis access stenosis showed that Dyslipidemia was significantly related to the short
        initial patency rate, and Dyslipidemia was an important predictor of secondary patency loss.
        Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are a new type of
        lipid-lowering drug that can prevent vascular calcification. Previous studies have shown that
        PCSK9 inhibitors have good lipid-lowering effects in both MHD patients and nondialysis
        patients, and the use of PSK9 inhibitors at the same dose as nondialysis patients is safe in
        MHD patients. There are currently few studies on the use of paclitaxel-releasing balloon
        dilation combined with PCSK9 inhibitors to improve autologous internal fistula. Therefore,
        the investigators applied a prospective, randomized, and controlled study method to
        preliminarily explore the effect of paclitaxel releasing balloon combined with PCSK9
        inhibitor on improving the postoperative patency rate of AVF and the safety of the combined
        application.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Value of vessel diameter
  time frame: 24 week, 48 week
  description: ultrasonic measurement
  measure: Value of volume of blood flow
  time frame: 24 week, 48 week
  description: ultrasonic measurement
  measure: Value of peak systolic velocity ratio（PSVR）
  time frame: 24 week, 48 week
  description: ultrasonic measurement
  measure: Incidence of Re intervention of fistula
  time frame: 48 week
  description: Event recording
  measure: Endometrium
  time frame: 24 week, 48 week
  description: Ultrasonic measurement of changes in thickness of vascular intima , expressed in millimeters
  measure: RA
  time frame: 24 week, 48 week
  description: Arteriovenous fistula recirculation rate
  measure: BTM
  time frame: 24 week, 48 week
  description: Blood temperature monitoring, testing of specific modules of the hemodialysis machine. Expressed as a percentage.
  measure: Adequacy of dialysis
  time frame: 24 week, 48 week
  description: spKT/V
  measure: Blood routine
  time frame: 12 week, 24 week, 48 week
  description: Concentration of hemoglobin, white blood cell count, platelet
  measure: liver function
  time frame: 12 week, 24 week, 48 week
  description: Concentration of GPT, GOT
  measure: Concentration of blood sugar
  time frame: 12 week, 24 week, 48 week
  measure: Concentration of CRP
  time frame: 12 week, 24 week, 48 week
  measure: blood lipids
  time frame: 12 week, 24 week, 48 week
  description: Concentration of cholesterol, triglyceride, LDL-c, HDL
  arm group label: PCSK9i group
  arm group type: Experimental
  description: treatment group
  arm group label: control group
  arm group type: No Intervention
  description: control group
  intervention type: Biological
  intervention name: pcsk9 inhibitor
  description: The treatment group received postoperative use of 140 mg of Ribavirin, administered every two weeks, with 140 mg administered subcutaneously for a total of 48 weeks. There was no additional intervention with lipid-lowering drugs in the control group.
  arm group label: PCSK9i group
  criteria: 
  gender: All
  minimum age: 17 Years
  maximum age: 76 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: PCSK9 Inhibitors