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/NCT06001827</url>
    </required_header>
    <id_info>
      <org_study_id>VENO-CIP002</org_study_id>
      <nct_id>NCT06001827</nct_id>
    </id_info>
    <brief_title>SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study</brief_title>
    <acronym>SAVE-FistulaS</acronym>
    <official_title>SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VenoStent</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VenoStent</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, randomized, multi-center clinical trial for chronic kidney disease&#xD;
        (CKD) patients referred for creation of a new AVF in order to assess the safety and&#xD;
        effectiveness of SelfWrap, a bioabsorbable perivascular wrap.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-center, prospective, randomized, double-arm, single-blind, evaluator-blinded&#xD;
        clinical trial for CKD patients referred for creation of a new AVF. This study will involve&#xD;
        approximately 200 participants from up to 20 investigational sites, randomized 1:1 to&#xD;
        treatment with the SelfWrap or the untreated AVF control (i.e. standard of care, SOC).&#xD;
        Participants will be followed for a duration of 36 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">December 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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Unassisted Maturation by 180 days</measure>
      <time_frame>Assessed at up to 6 months</time_frame>
      <description>A participant who is either 1) on hemodialysis on or before day 150 and the AVF has been cannulated with two needles for at least 75% of dialysis sessions within any 4 consecutive week period to achieve the prescribed dialysis by the 180 day follow up, and did not require any facilitative endovascular or surgical intervention to achieve this, or 2) is not on hemodialysis on or before day 150, but ultrasound measurements by the 180 day follow up indicate a proximal arterial flow rate of at least 500 mL/min and a vein inner diameter of at least 5.0 mm at 5 - 8 cm from the anastomosis, and did not require any facilitative endovascular or surgical intervention through the 180 day follow up.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of access-related events through 180 days</measure>
      <time_frame>Assessed at up to 6 months</time_frame>
      <description>Rate of access-related events through the 180 day follow up</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Chronic Kidney Diseases</condition>
    <condition>End Stage Renal Disease</condition>
    <condition>Arteriovenous Fistula</condition>
    <condition>Hemodialysis Access Failure</condition>
    <condition>ESRD</condition>
    <condition>Vascular Access Complication</condition>
    <condition>Renal Failure</condition>
    <condition>Catheter Complications</condition>
    <condition>Catheter Dysfunction</condition>
    <condition>Renal Insufficiency</condition>
    <arm_group>
      <arm_group_label>Treatment Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Arm</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>AVF creation surgery without any intervention (untreated AVF control, or standard of care)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SelfWrap Bioabsorbable Perivascular Wrap</intervention_name>
      <description>SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.</description>
      <arm_group_label>Treatment Arm</arm_group_label>
      <other_name>SelfWrap</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Untreated AVF Control</intervention_name>
      <description>AVF creation surgery without any intervention</description>
      <arm_group_label>Control Arm</arm_group_label>
      <other_name>Standard of Care</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age of at least 18 years&#xD;
  &#xD;
            -  Referred for creation of a new AVF&#xD;
  &#xD;
            -  Willing and able to comply with study requirements, communicate with the study team,&#xD;
               and attend follow up visits over a period of 36 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Planned index procedure to revise or repair an existing fistula&#xD;
  &#xD;
            -  Target artery inner diameter &lt; 2.0 mm, as measured by ultrasound while the target arm&#xD;
               is under tourniquet pressure and anesthesia&#xD;
  &#xD;
            -  Target vein inner diameter &lt; 2.0 mm, as measured by ultrasound while the target arm is&#xD;
               under tourniquet pressure and anesthesia&#xD;
  &#xD;
            -  Significant (at least 50%) stenosis at the target vein on the side of surgery (between&#xD;
               the planned anastomosis site and the axillary vein), as diagnosed by preoperative&#xD;
               ultrasound&#xD;
  &#xD;
            -  Known central venous stenosis of at least 50% on the side of surgery&#xD;
  &#xD;
            -  Presence of a stent or a stent graft within the access circuit&#xD;
  &#xD;
            -  Known or suspected coagulation disorder that, in the opinion of the Investigator, puts&#xD;
               too much risk on the patient for AVF creation&#xD;
  &#xD;
            -  Known or suspected active infection at the time of surgery&#xD;
  &#xD;
            -  Congestive heart failure NYHA class 4&#xD;
  &#xD;
            -  Prior steal on the side of surgery;&#xD;
  &#xD;
            -  Enrolled in another investigational drug, device, or biological study, or was&#xD;
               previously enrolled in this study&#xD;
  &#xD;
            -  Life expectancy less than 12 months&#xD;
  &#xD;
            -  Expected to undergo kidney transplant surgery within 6 months of enrollment&#xD;
  &#xD;
            -  Expected to undergo home hemodialysis&#xD;
  &#xD;
            -  Females of childbearing potential (premenopausal and not surgically sterile) without&#xD;
               documented current negative pregnancy test at screening&#xD;
  &#xD;
            -  Presence of a comorbid condition that, in the opinion of the Investigator, may&#xD;
               significantly confound the collection of safety and efficacy data in this study&#xD;
  &#xD;
            -  Unwillingness or inability to give consent and/or comply with the study follow up&#xD;
               schedule&#xD;
  &#xD;
            -  Any health condition, which in the opinion of the Investigator, would interfere with&#xD;
               the safety of the participant or the participant's ability to comply with the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Timothy Boire, PhD</last_name>
      <role>Study Director</role>
      <affiliation>VenoStent, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mark Barakat, MD</last_name>
      <phone>(832) 429-5362</phone>
      <email>mark.barakat@venostent.com</email>
    </overall_contact>
    <link>
      <url>https://www.venostent.com</url>
      <description>VenoStent website</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Vascular Surgery</keyword>
    <keyword>Vascular Access</keyword>
    <keyword>Nephrology</keyword>
    <keyword>Bioabsorbable</keyword>
    <keyword>Perivascular Wrap</keyword>
    <keyword>External Support</keyword>
    <keyword>Hemodialysis</keyword>
    <keyword>Dialysis</keyword>
    <keyword>Chronic Kidney Disease</keyword>
    <keyword>End Stage Renal Disease</keyword>
    <keyword>Arteriovenous Fistula</keyword>
    <keyword>AVF</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
      <mesh_term>Kidney Failure, Chronic</mesh_term>
      <mesh_term>Renal Insufficiency</mesh_term>
      <mesh_term>Arteriovenous Fistula</mesh_term>
      <mesh_term>Fistula</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06001827
  org study id: VENO-CIP002
  nct id: NCT06001827
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  This is a prospective, randomized, multi-center clinical trial for chronic kidney disease
        (CKD) patients referred for creation of a new AVF in order to assess the safety and
        effectiveness of SelfWrap, a bioabsorbable perivascular wrap.
  This is a multi-center, prospective, randomized, double-arm, single-blind, evaluator-blinded
        clinical trial for CKD patients referred for creation of a new AVF. This study will involve
        approximately 200 participants from up to 20 investigational sites, randomized 1:1 to
        treatment with the SelfWrap or the untreated AVF control (i.e. standard of care, SOC).
        Participants will be followed for a duration of 36 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Unassisted Maturation by 180 days
  time frame: Assessed at up to 6 months
  description: A participant who is either 1) on hemodialysis on or before day 150 and the AVF has been cannulated with two needles for at least 75% of dialysis sessions within any 4 consecutive week period to achieve the prescribed dialysis by the 180 day follow up, and did not require any facilitative endovascular or surgical intervention to achieve this, or 2) is not on hemodialysis on or before day 150, but ultrasound measurements by the 180 day follow up indicate a proximal arterial flow rate of at least 500 mL/min and a vein inner diameter of at least 5.0 mm at 5 - 8 cm from the anastomosis, and did not require any facilitative endovascular or surgical intervention through the 180 day follow up.
  measure: Rate of access-related events through 180 days
  time frame: Assessed at up to 6 months
  description: Rate of access-related events through the 180 day follow up
  arm group label: Treatment Arm
  arm group type: Experimental
  description: Treated with SelfWrap Bioabsorbable Perivascular Wrap during AVF creation surgery
  arm group label: Control Arm
  arm group type: Sham Comparator
  description: AVF creation surgery without any intervention (untreated AVF control, or standard of care)
  intervention type: Device
  intervention name: SelfWrap Bioabsorbable Perivascular Wrap
  description: SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.
  arm group label: Treatment Arm
  other name: SelfWrap
  intervention type: Procedure
  intervention name: Untreated AVF Control
  description: AVF creation surgery without any intervention
  arm group label: Control Arm
  other name: Standard of Care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Timothy Boire, PhD
  role: Study Director
  affiliation: VenoStent, Inc.
  last name: Mark Barakat, MD
  phone: (832) 429-5362
  email: mark.barakat@venostent.com
  url: https://www.venostent.com
  description: VenoStent website
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  mesh term: Kidney Failure, Chronic
  mesh term: Renal Insufficiency
  mesh term: Arteriovenous Fistula
  mesh term: Fistula
  sharing ipd: No