<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/NCT04446546</url>
  </required_header>
  <id_info>
    <org_study_id>2020PI096</org_study_id>
    <nct_id>NCT04446546</nct_id>
  </id_info>
  <brief_title>Results of Cold Stored Allografts in Vascular Access</brief_title>
  <acronym>RAVASC</acronym>
  <official_title>Long Term Outcomes of Cold Stored Venous Allografts in Vascular Access for Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>No</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>
      Vascular access creation in patients with renal failure requiring long-term hemodialysis can&#xD;
      be a challenge when there is no more autologous material or in case of infection, in a&#xD;
      population undergoing long term dialysis with a longer life-expectancy. Many types of grafts&#xD;
      have been used, with its advantages and drawbacks, such as prosthetic grafts (PTFE). Over the&#xD;
      past decade, surgeons have used cold stored venous allografts as a biological conduit for&#xD;
      hemodialysis, with the idea of avoiding most of major complications including a lower&#xD;
      incidence of infection and steal syndrome, with patencies at least equivalent to PTFE. There&#xD;
      is only a few data in the litterature, but many surgical teams use it when there is no&#xD;
      autologous material or in case of infection.&#xD;
&#xD;
      The aim of the study is to give the primary patency of vascular access with this technique,&#xD;
      and to assess its long term outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intervention free vascular access survival (in days)</measure>
    <time_frame>30 days</time_frame>
    <description>The interval in days between the vascular access creation and the first successful re intervention (primary patency)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention free vascular access survival (in days)</measure>
    <time_frame>6 months</time_frame>
    <description>The interval in days between the vascular access creation and the first successful re intervention (primary patency)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention free vascular access survival (in days)</measure>
    <time_frame>1 year</time_frame>
    <description>The interval in days between the vascular access creation and the first successful re intervention (primary patency)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention free vascular access survival (in days)</measure>
    <time_frame>2 years</time_frame>
    <description>The interval in days between the vascular access creation and the first successful re intervention (primary patency)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention free vascular access survival (in days)</measure>
    <time_frame>3 years</time_frame>
    <description>The interval in days between the vascular access creation and the first successful re intervention (primary patency)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thrombosis free vascular access survival (in days)</measure>
    <time_frame>30 days</time_frame>
    <description>The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombosis free vascular access survival (in days)</measure>
    <time_frame>90 days</time_frame>
    <description>The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombosis free vascular access survival (in days)</measure>
    <time_frame>6 months</time_frame>
    <description>The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombosis free vascular access survival (in days)</measure>
    <time_frame>1 year</time_frame>
    <description>The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombosis free vascular access survival (in days)</measure>
    <time_frame>2 years</time_frame>
    <description>The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thrombosis free vascular access survival (in days)</measure>
    <time_frame>3 years</time_frame>
    <description>The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abandonment of the vascular access (in days)</measure>
    <time_frame>30 days</time_frame>
    <description>The interval in days between the vascular access creation and its abandonment (secondary patency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abandonment of the vascular access (in days)</measure>
    <time_frame>90 days</time_frame>
    <description>The interval in days between the vascular access creation and its abandonment (secondary patency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abandonment of the vascular access (in days)</measure>
    <time_frame>6 months</time_frame>
    <description>The interval in days between the vascular access creation and its abandonment (secondary patency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abandonment of the vascular access (in days)</measure>
    <time_frame>1 year</time_frame>
    <description>The interval in days between the vascular access creation and its abandonment (secondary patency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abandonment of the vascular access (in days)</measure>
    <time_frame>2 years</time_frame>
    <description>The interval in days between the vascular access creation and its abandonment (secondary patency)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abandonment of the vascular access (in days)</measure>
    <time_frame>3 years</time_frame>
    <description>The interval in days between the vascular access creation and its abandonment (secondary patency)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Early and late complications (in days)</measure>
    <time_frame>30 days</time_frame>
    <description>The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Early and late complications (in days)</measure>
    <time_frame>90 days</time_frame>
    <description>The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Early and late complications (in days)</measure>
    <time_frame>6 months</time_frame>
    <description>The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Early and late complications (in days)</measure>
    <time_frame>1 year</time_frame>
    <description>The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Early and late complications (in days)</measure>
    <time_frame>2 years</time_frame>
    <description>The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Early and late complications (in days)</measure>
    <time_frame>3 years</time_frame>
    <description>The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of the socio-demographic and clinical characteristics of the patients on secondary patency</measure>
    <time_frame>3 years</time_frame>
    <description>Compare the duration of secondary patency according to the socio-demographic and clinical characteristics of the patients</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>End Stage Renal Failure on Dialysis</condition>
  <condition>Hemodialysis Access Failure</condition>
  <arm_group>
    <arm_group_label>Cold Stored Allograft Vascular Access</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vascular access by pass using a cold stored venous allograft</intervention_name>
    <description>Creation or surgical repair of a vascular access for hemodialysis using a cold venous allograft</description>
    <arm_group_label>Cold Stored Allograft Vascular Access</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hemodialysis patient with end-stage renal disease for whom a allograft was used for his&#xD;
        hemodialysis access.&#xD;
&#xD;
          -  The patient can be treated on an ambulatory surgery or in full hospitalization&#xD;
&#xD;
          -  In the surgical departments having given their agreement to participate in our study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  End stage renal failure patient requiring hemodialysis&#xD;
&#xD;
          -  With the placement of a venous allograft for a hemodialysis approach&#xD;
&#xD;
          -  Who underwent a surgery between January 1, 2014 and December 31, 2018 in a vascular&#xD;
             surgery department participating in our study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient &lt;18 years old, or under guardianship / curatorship&#xD;
&#xD;
          -  Patient objecting to the use of his personal data in the context of research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Departement of Vascular Surgery Nancy University Hospital</name>
      <address>
        <city>Nancy</city>
        <state>Lorraine</state>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Schmidli J, Widmer MK, Basile C, de Donato G, Gallieni M, Gibbons CP, Haage P, Hamilton G, Hedin U, Kamper L, Lazarides MK, Lindsey B, Mestres G, Pegoraro M, Roy J, Setacci C, Shemesh D, Tordoir JHM, van Loon M, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Lindholt J, Naylor R, Vega de Ceniga M, Vermassen F, Verzini F, Esvs Guidelines Reviewers, Mohaupt M, Ricco JB, Roca-Tey R. Editor's Choice - Vascular Access: 2018 Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Jun;55(6):757-818. doi: 10.1016/j.ejvs.2018.02.001. Epub 2018 May 2. No abstract available.</citation>
    <PMID>29730128</PMID>
  </reference>
  <reference>
    <citation>Heintjes RJ, Eikelboom BC, Steijling JJ, van Reedt Dortland RW, van der Heijden FH, Bastini M, van der Graaf Y, Blankestijn PJ, Vos J. The results of denatured homologous vein grafts as conduits for secondary haemodialysis access surgery. Eur J Vasc Endovasc Surg. 1995 Jan;9(1):58-63. doi: 10.1016/s1078-5884(05)80226-6.</citation>
    <PMID>7664014</PMID>
  </reference>
  <reference>
    <citation>Schneider M, Barrou B, Cluzel P, Hamani A, Bitker MO, Richard F. [Value of preserved saphenous vein graft for the creation of access ports in hemodialyzed patients: report of 309 cases]. Prog Urol. 2003 Sep;13(4):585-91. French.</citation>
    <PMID>14650287</PMID>
  </reference>
  <reference>
    <citation>Berardinelli L. Grafts and graft materials as vascular substitutes for haemodialysis access construction. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):203-11. doi: 10.1016/j.ejvs.2006.01.001. Epub 2006 Feb 20.</citation>
    <PMID>16490368</PMID>
  </reference>
  <reference>
    <citation>Nedved K, Suchy T, Halova J, Malicky M, Gorun P, Vitvar P. Allogenous vein graft as vascular access for hemodialysis--lost battle? J Vasc Access. 2012 Jul-Sep;13(3):366-73. doi: 10.5301/jva.5000062.</citation>
    <PMID>22367646</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hemodialysis</keyword>
  <keyword>Vascular access</keyword>
  <keyword>Homologous vein</keyword>
  <keyword>Allogenous vein graft</keyword>
  <keyword>Cold stored venous allograft</keyword>
  <keyword>Saphenous vein</keyword>
  <keyword>Haemodialysis</keyword>
  <keyword>Biological graft</keyword>
  <keyword>Patency</keyword>
  <keyword>Primary patency</keyword>
  <keyword>Secondary patency</keyword>
  <keyword>Complication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04446546
org study id: 2020PI096
nct id: NCT04446546
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vascular access creation in patients with renal failure requiring long-term hemodialysis can
      be a challenge when there is no more autologous material or in case of infection, in a
      population undergoing long term dialysis with a longer life-expectancy. Many types of grafts
      have been used, with its advantages and drawbacks, such as prosthetic grafts (PTFE). Over the
      past decade, surgeons have used cold stored venous allografts as a biological conduit for
      hemodialysis, with the idea of avoiding most of major complications including a lower
      incidence of infection and steal syndrome, with patencies at least equivalent to PTFE. There
      is only a few data in the litterature, but many surgical teams use it when there is no
      autologous material or in case of infection.

      The aim of the study is to give the primary patency of vascular access with this technique,
      and to assess its long term outcomes.
observational model: Case-Only
time perspective: Retrospective
measure: Intervention free vascular access survival (in days)
time frame: 30 days
description: The interval in days between the vascular access creation and the first successful re intervention (primary patency)
measure: Intervention free vascular access survival (in days)
time frame: 6 months
description: The interval in days between the vascular access creation and the first successful re intervention (primary patency)
measure: Intervention free vascular access survival (in days)
time frame: 1 year
description: The interval in days between the vascular access creation and the first successful re intervention (primary patency)
measure: Intervention free vascular access survival (in days)
time frame: 2 years
description: The interval in days between the vascular access creation and the first successful re intervention (primary patency)
measure: Intervention free vascular access survival (in days)
time frame: 3 years
description: The interval in days between the vascular access creation and the first successful re intervention (primary patency)
measure: Thrombosis free vascular access survival (in days)
time frame: 30 days
description: The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)
measure: Thrombosis free vascular access survival (in days)
time frame: 90 days
description: The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)
measure: Thrombosis free vascular access survival (in days)
time frame: 6 months
description: The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)
measure: Thrombosis free vascular access survival (in days)
time frame: 1 year
description: The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)
measure: Thrombosis free vascular access survival (in days)
time frame: 2 years
description: The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)
measure: Thrombosis free vascular access survival (in days)
time frame: 3 years
description: The interval in days between the vascular access creation and the first occlusion with a successful re intervention (primary assisted pantency)
measure: Abandonment of the vascular access (in days)
time frame: 30 days
description: The interval in days between the vascular access creation and its abandonment (secondary patency)
measure: Abandonment of the vascular access (in days)
time frame: 90 days
description: The interval in days between the vascular access creation and its abandonment (secondary patency)
measure: Abandonment of the vascular access (in days)
time frame: 6 months
description: The interval in days between the vascular access creation and its abandonment (secondary patency)
measure: Abandonment of the vascular access (in days)
time frame: 1 year
description: The interval in days between the vascular access creation and its abandonment (secondary patency)
measure: Abandonment of the vascular access (in days)
time frame: 2 years
description: The interval in days between the vascular access creation and its abandonment (secondary patency)
measure: Abandonment of the vascular access (in days)
time frame: 3 years
description: The interval in days between the vascular access creation and its abandonment (secondary patency)
measure: Early and late complications (in days)
time frame: 30 days
description: The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)
measure: Early and late complications (in days)
time frame: 90 days
description: The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)
measure: Early and late complications (in days)
time frame: 6 months
description: The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)
measure: Early and late complications (in days)
time frame: 1 year
description: The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)
measure: Early and late complications (in days)
time frame: 2 years
description: The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)
measure: Early and late complications (in days)
time frame: 3 years
description: The interval in days between the vascular access creation and the occurence of complications (stenosis, thrombosis, failure, hyperflow, distal ischemia, aneurysm)
measure: Incidence of the socio-demographic and clinical characteristics of the patients on secondary patency
time frame: 3 years
description: Compare the duration of secondary patency according to the socio-demographic and clinical characteristics of the patients
arm group label: Cold Stored Allograft Vascular Access
intervention type: Procedure
intervention name: Vascular access by pass using a cold stored venous allograft
description: Creation or surgical repair of a vascular access for hemodialysis using a cold venous allograft
arm group label: Cold Stored Allograft Vascular Access
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: Schmidli J, Widmer MK, Basile C, de Donato G, Gallieni M, Gibbons CP, Haage P, Hamilton G, Hedin U, Kamper L, Lazarides MK, Lindsey B, Mestres G, Pegoraro M, Roy J, Setacci C, Shemesh D, Tordoir JHM, van Loon M, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Lindholt J, Naylor R, Vega de Ceniga M, Vermassen F, Verzini F, Esvs Guidelines Reviewers, Mohaupt M, Ricco JB, Roca-Tey R. Editor's Choice - Vascular Access: 2018 Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Jun;55(6):757-818. doi: 10.1016/j.ejvs.2018.02.001. Epub 2018 May 2. No abstract available.
PMID: 29730128
citation: Heintjes RJ, Eikelboom BC, Steijling JJ, van Reedt Dortland RW, van der Heijden FH, Bastini M, van der Graaf Y, Blankestijn PJ, Vos J. The results of denatured homologous vein grafts as conduits for secondary haemodialysis access surgery. Eur J Vasc Endovasc Surg. 1995 Jan;9(1):58-63. doi: 10.1016/s1078-5884(05)80226-6.
PMID: 7664014
citation: Schneider M, Barrou B, Cluzel P, Hamani A, Bitker MO, Richard F. [Value of preserved saphenous vein graft for the creation of access ports in hemodialyzed patients: report of 309 cases]. Prog Urol. 2003 Sep;13(4):585-91. French.
PMID: 14650287
citation: Berardinelli L. Grafts and graft materials as vascular substitutes for haemodialysis access construction. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):203-11. doi: 10.1016/j.ejvs.2006.01.001. Epub 2006 Feb 20.
PMID: 16490368
citation: Nedved K, Suchy T, Halova J, Malicky M, Gorun P, Vitvar P. Allogenous vein graft as vascular access for hemodialysis--lost battle? J Vasc Access. 2012 Jul-Sep;13(3):366-73. doi: 10.5301/jva.5000062.
PMID: 22367646
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic
sharing ipd: No